Effect of Probiotics on Infant's Fecal Microbiota Composition (BABYCARE)

February 10, 2025 updated by: AB Biotics, SA

Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants

Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.

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.
Interventional

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.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.
  • Name: Gerardo Rodríguez Martínez, MD
  • Phone Number: +34 654633910
  • Email: gerard@unizar.es

Study Contact Backup

Study Locations

  • Mexico
    • Puebla
      • Alcaldía Coyoacán, Puebla, Mexico, 04530
        • Not yet recruiting
        • Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
        • Contact:
  • Spain
    • Aragón
      • Zaragoza, Aragón, Spain, 50012
        • Recruiting
        • Clínica Viamed Montecanal
        • Contact:
          • Gerardo Rodríguez Martínez, MD
          • Phone Number: +34 654633910
          • Email: gerard@unizar.es

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

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy infants
  • Age between 1 and 90 days
  • Gestational age between 37 and 42 weeks
  • Appropiate birth weight for gestational age (between P10 and P90)
  • APGAR test score for birth normal at 1' and 5' of 7-10
  • Whose parents accept the follow-up of the study procedures and sign the informed consent

Exclusion Criteria:

  • Infants participating in other clinical study
  • Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
  • Infants who have taken antibiotics 4 weeks prior the start study
  • Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
  • Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
  • Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
  • TORCH complex infections
  • Every other diseases related with the immune system
  • Parents who can not accomplish the follow-up of the study (medical criterium)

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental 1
Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Dietary supplement: Food Supplement 1
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Experimental: Experimental 2
Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.
Dietary supplement: Food Supplement 2
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
Placebo Comparator: Placebo
Sunflower oil
Dietary supplement: Placebo
5 drops/day for 3 months of sunflower oil

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
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
Time Frame: day 0, month 3
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
day 0, month 3

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
Weight change
Time Frame: day 0, month 1, month 2, month 3
Change in weight (g per day) between day 0 and month 3
day 0, month 1, month 2, month 3
Length change
Time Frame: day 0, month 1, month 2, month 3
Change in length (cm) between day 0 and month 3
day 0, month 1, month 2, month 3
Head circumference change
Time Frame: day 0, month 1, month 2, month 3
Change in head circumference (cm) between day 0 and month 3
day 0, month 1, month 2, month 3
BMI change
Time Frame: day 0, month 1, month 2, month 3
Change in BMI (kg/m2) between day 0 and month 3
day 0, month 1, month 2, month 3
Frequency of depositions
Time Frame: day 0, month 1, month 2, month 3
Frequency of depositions (number stools/day) documented in participants diary
day 0, month 1, month 2, month 3
Consistency of stools
Time Frame: day 0, month 1, month 2, month 3
Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid
day 0, month 1, month 2, month 3
Infant colic
Time Frame: day 0, month 1, month 2, month 3
Incidence of infant colic, defined as prolonged and recurrent periods of crying, agitation, or irritability without apparent cause that cannot be prevented or resolved by your caregivers, for three or more hours daily for three or more days a week
day 0, month 1, month 2, month 3
Vomiting
Time Frame: day 0, month 1, month 2, month 3
Incidence of vomiting (n/day)
day 0, month 1, month 2, month 3
Sleeping habits
Time Frame: day 0, month 1, month 2, month 3
Nocturnal sleeping (min/day), total sleeping hours (min/day)
day 0, month 1, month 2, month 3
Incidence of infections
Time Frame: day 0, month 1, month 2, month 3
Number and duration (in days) of any type of infectious episodes
day 0, month 1, month 2, month 3
Fever
Time Frame: day 0, month 1, month 2, month 3
Number of days with fever (axial body temperature higher than 37.5 ºC)
day 0, month 1, month 2, month 3
Antibiotics
Time Frame: day 0, month 1, month 2, month 3
Number of days with antibiotic treatment
day 0, month 1, month 2, month 3
Change in fecal microbiota composition
Time Frame: day 0, month 3
Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing
day 0, month 3
sIgA in stool samples
Time Frame: day 0, month 3
Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA
day 0, month 3
Calprotectin
Time Frame: day 0, month 3
Analysis of fecal calprotectin through ELISA
day 0, month 3

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.
AB Biotics, SA

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.
Ministry of Science and Innovation, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
June 1, 2022

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.
August 31, 2025

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.
December 31, 2025

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).
August 26, 2022

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.
August 30, 2022

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.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

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.
March 25, 2025

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.
February 10, 2025

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.
October 1, 2024

More Information

Terms related to this study

Keywords

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.
  • AB-BABYCARE-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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