Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach (BeBiCo)

November 11, 2024 updated by: Insel Gruppe AG, University Hospital Bern

Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood.

Aims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome.

Methods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps.

Species composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content.

Expected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Methods for sample analysis:

For the primary objective and outcome/ endpoint of the study, bacterial content of infant stool will be analyzed by:

  • Mass spectrometry to assess intestinal content (metabolome). Techniques have been established in the laboratory of Prof. U. Sauer who already collaborated with the investigators' group in previous studies.
  • 16S ribosomal ribonucleic acid (rRNA) sequencing for bacterial species composition as well as microbial diversity.
  • Bacterial full genome metagenomics shotgun sequencing to identify bacterial genes present (metabolic potential of the microbiota).
  • Bacterial mRNA sequencing to assess transcription and a functional role of the microbiota (metabolic activity of microbiota).
  • Analysis of the intestinal virome and eukaryotic intestinal populations by appropriate sequencing or culturing techniques.
  • Analysis of IgA antibodies in human milk and stool and the interaction of antibodies with intestinal bacteria.

For the secondary endpoints identical analyses will be performed in skin swabs, maternal milk, maternal vaginal swabs and maternal stool. Parameters for infant growth, neurodevelopment, immune maturation and potential occurrence of pathology will be assessed at every visit. Maternal and infant nutrition, hygiene, socioeconomic status and clinical history will be assessed by questionnaires at every visit. Milk samples will further be analyzed for their cellular contents by flow cytometry and single cell RNA-sequencing, as well as for cytokines and exosome-based miRNAs. All biosamples will be analyzed by mass spectrometry to assess impact of the environment on infant metabolism and physiology.

Further follow-up experiments with the acquired samples are possible. Specifically, individual bacteria strains can be isolated and cultured in vitro and also tested alone or in combination in experimental animals.

Bacterial sequencing by the methods described above will also inevitably identify maternal or infant DNA sequences, since metagenomic shotgun sequencing cannot differentiate between bacterial and human DNA. These human DNA sequences will not be analyzed within the scope of this project. However, these sequences might be the subject of future studies. Study participants will therefore be asked for permission to analyze human DNA from mother and/ or child at the page for "further analyses" within the consent form. An option to "opt out" for human DNA analysis will be provided and refusal will not lead to exclusion from the study.

Any findings of clear relevance to the health of the participant (i.e. mother or child) will be reported to the participant in collaboration with their treating pediatrician. Participants will need to inform the study team if they do not wish to be informed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital of Bern - Insel Spital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

At recruitment: Healthy pregnant women in the area of Bern. On Follow-up: baby-mother pairs in the area of Bern

Description

Inclusion Criteria:

  • Signed informed consent.
  • Ability to understand and follow study procedures and understand informed consent
  • From week 20 of pregnancy until birth
  • General good health, i.e. absence of major severe medical/ surgical/ psychiatric condition requiring ongoing management. Minor well controlled conditions (e.g. medically controlled arterial hypertension, occupational asthma, gestational diabetes mellitus) may be present.
  • Absence of known severe embryonal pathology, expected normal pregnancy (e.g. minor conditions including twin/ triplet pregnancy, final pelvic position may be present)
  • Age 18-45 years.

Exclusion Criteria:

• Participation in another clinical study interfering with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 0-3 days after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 0-3 days after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 10 days after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 10 days after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 6 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 6 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 10 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 10 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 14 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 14 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 24 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 24 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 36 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 36 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 48 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 48 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 96 weeks after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 96 weeks after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 5 years after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 5 years after birth
Maturation of a healthy infant intestinal microbiota regarding complexity of species composition and metabolic activities.
Time Frame: Infant stool samples will be collected 10 years after birth
The investigators are aiming for a deep understanding of the maturation of a healthy infant intestinal microbiota considering composition, diversity and metabolic activities. The investigators will characterise the composition, metabolic potential and activity at various time points by advanced techniques (16S sequencing, metagenomics shotgun sequencing and mRNA sequencing) and the metabolites present by mass spectrometry (see "detailed description") . Using this information, the investigators will estimate networks of metabolic activity of the microbiota. Network analysis can be informed by information regarding small molecules present. The trajectories shared by the microbiota of most healthy infants will be considered normal.
Infant stool samples will be collected 10 years after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transfer of the maternal microbiota to the infant
Time Frame: Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.

To understand the transfer of the maternal microbiota to the infant. The investigators will identify bacterial species (or operational taxonomic units, OTU) in the maternal microbiota in maternal stool, maternal skin, vaginal environment, maternal placenta, as well as maternal milk at various points in time and correlate these parameters to identified species/ OTU in the intestinal and skin microbiota of the infant at various points in time (for methodology see "detailed description").

Biological samples will be collected at:

  • Maternal vaginal swab: Enrolment.
  • Placenta swab: Birth.
  • Maternal stool and skin swabs: Enrolment, 10 days, 6 months and 1 year after birth.
  • Maternal milk samples, if nursing: 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks after birth.
  • Infant stool and skin probes: 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
Impact of low resources with poor nutrition and poor hygiene in developing countries on the maturation of the intestinal microbiota
Time Frame: 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
To understand the impact of low resources with poor nutrition and poor hygiene in developing countries on the maturation of the intestinal microbiota. Children from the University of Zimbabwe birth cohort were followed in a similar manner as planned for the children from the Bern infant microbiota study with the same acquisition of biological samples. The investigators will use microbiota characteristics from endpoint 1 to compare microbiota maturation in healthy Swiss infants to microbiota maturation in healthy Zimbabwean children as well as children with environmental enteropathy and stunted growth.
0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
Impact of variations of the normal environment in Switzerland on microbiota development.
Time Frame: Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
To understand the impact of variations of the normal environment in Switzerland on microbiota development. To this end we will use parameters for nutrition and socioeconomic status, microbiota characteristics, and metabolomics and correlate those with parameters for infant development and immunity.
Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
Impact of the microbiota on child development and health.
Time Frame: Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.

To understand the impact of the microbiota on child development and health. The investigators will correlate infant microbiota characteristics from the primary endpoint with

  1. Parameters for physical development (size, weight, percentiles, head circumference, mid upper arm circumference, waist to hip ratio)
  2. Parameters for neurodevelopment and child behaviour
  3. Onset/ occurrence of pathology (obesity, abdominal pain, new onset of allergies, asthma, eczema, number of infectious complications, physician consultations outside regular preventive medical checkups).

Using questionnaires, the investigators will assess clinical parameters and parameters for child development but also acquire information regarding infectious complications, allergies and abdominal pain at enrolment and on the same follow-up dates as stated in the primary outcome section.
Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
Effects of maternal microbiota on immunomodulatory properties of breast milk and immune maturation in the newborn
Time Frame: Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.
5) To understand the extent to which the maternal microbiota and maternal diet affects the immunomodulatory properties of breast milk and how those properties in turn influence immune maturation in the newborn, we will analyse the composition of stool and breast milk samples in regard to metabolites, cellular components, cytokines and miRNA. We will further use the material to test the impact of maternal milk in vitro (cell culture) and in vivo (mice). Immunomodulatory mechanisms will be identified and correlating changes in development and maturation of the immune system of the newborn will be analysed. (For methodology see " detailed description")
Enrolment, 0-3 days, 10 days, 6 weeks, 10 weeks, 14 weeks, 24 weeks, 36 weeks, 48 weeks, 96 weeks, 5 years and 10 years after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin Misselwitz, Professor, University Hospital of Bern - Insel Spital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-00510
  • 3962 (Direktion Lehre und Forschung Insel Spital Bern)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Participant level-data and statistical code will be published together with the results of our analyses. However, some restrictions regarding sharing of individual participant data apply according to Swiss law.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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