Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions

July 13, 2023 updated by: Université Catholique de Louvain
The aim of this study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. For this purpose, breath volatile metabolites (BVM) will be analyzed throughout test days in fasting state and after standardized meals using selected ion flow tube mass spectrometry (SIFT-MS). In addition, gut microbial functions linked notably to hydrogen/methane production, carbohydrates utilization (CAZymes), and in the production of other volatile metabolites of interest (i.e. indole, fatty acid derivatives, ...) will be unraveled through microbiome sequencing data analysis (in silico), metabolomic analyses and measurement of enzymatic activities from saliva, urine and/or fecal samples.

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.

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.
100

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.

Study Locations

  • Belgium
    • Brabant Wallon
      • Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
        • Not yet recruiting
        • Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN
        • Contact:
          • Louise Deldicque, Prof.
    • Brussels
      • Woluwe-Saint-Lambert, Brussels, Belgium, 1200
        • Recruiting
        • Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain
        • Contact:
          • Nathalie Delzenne, Prof.
      • Woluwe-Saint-Lambert, Brussels, Belgium, 1200
        • Recruiting
        • Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS
        • Contact:
          • Louise Deldicque, Prof.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Woman or man, aged of 18 to 65 years;
  • Body mass index (BMI) between 18 and 30 kg/m2;
  • Non-smoker;
  • Provision of signed and dated informed consent form;
  • Stated willingness to comply with all study procedures and availability for the duration of the study;
  • Speaking French.

Exclusion Criteria:

  • Subject with severe systemic disease (renal or hepatic failure, cancer, pancreatic cancer, chronic pancreatitis, asthma …)
  • Subject with a history or current chronic/severe gastrointestinal disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the digestive tract disease (Crohn's disease, ulcerative colitis), celiac disease or irritable bowel syndrome;
  • Subjects with a history of digestive tract surgery (except appendectomy);
  • Subject who had surgery within the two months prior to the study
  • Subjects with psychiatric problems and/or using antipsychotics
  • Current or recent (< 4 weeks) intake of antibiotics, fiber supplement, and/or any products modulating gut transit (laxative, anti-diarrheal, ...) or gut microbiota composition; these products will also be avoided for the duration of the study;
  • Chronic intake of drugs, except contraceptive drug;
  • Subject following a low-calorie diet and followed by a doctor or dietician in progress or recently (< 6 weeks);
  • Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, intrauterine device (IUD), abstinence, ...);
  • Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day);
  • Subjects having participated to another clinical trial two weeks before the screening test visit;
  • Subjects who practice an intense sport activity (more than 10 hours per week of intense activity);
  • Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate to the study.

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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.
Other: Screening
D-42 to D-7
Other: Screening visit
Subjects will be invited to perform the screening visit to sign the informed consent and then to ensure that they are able to participate in this study.
Other: Lactulose
D0
Other: Lactulose test
Fasted subjects (at least 10 hours) will receive on oral load of 10 g of lactulose. Then, exhaled H2 will be measured every 30 minutes during 4 hours.
Other: Meal 1
D14+/-7
Other: Administration of standardized meals with characterized dietary fiber content
Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.
Other: Meal 2
D16+/-7
Other: Administration of standardized meals with characterized dietary fiber content
Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.
Other: Meal 3
D18+/-7
Other: Administration of standardized meals with characterized dietary fiber content
Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.

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
Exhaled volatile compounds
Time Frame: Throughout the entire study, approximately during 24 months
Selected Ion flow tube mass spectrometry (SIFT-MS) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months

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
Gut microbiota
Time Frame: Throughout the entire study, approximately during 24 months
Illumina sequencing of 16S ribosomal deoxyribonucleic acid (rDNA), quantitative polymerase chain reaction (PCR)
Throughout the entire study, approximately during 24 months
Salivary microbiota
Time Frame: Throughout the entire study, approximately during 24 months
Illumina sequencing of 16SrDNA, quantitative PCR
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - discomfort
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - nausea
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - bloating
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - flatulences
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - gastrointestinal reflux
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - cramps
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - rumbling
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - burps
Time Frame: Throughout the entire study, approximately during 24 months
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom)
Throughout the entire study, approximately during 24 months
Gut microbiota metabolic capacity
Time Frame: Throughout the entire study, approximately during 24 months
Enzymatic analysis via in-vitro studies, incubation of fecal extracts
Throughout the entire study, approximately during 24 months
Exhaled hydrogen (H2)
Time Frame: Throughout the entire study, approximately during 24 months
Lactotest 202 - Area under the curve (calculated on 4 hours following lactulose ingestion)
Throughout the entire study, approximately during 24 months
Exhaled methane (CH4)
Time Frame: Throughout the entire study, approximately during 24 months
Lactotest 202 - Area under the curve (calculated on 8 hours following breakfast ingestion)
Throughout the entire study, approximately during 24 months
Exhaled carbon dioxide (CO2)
Time Frame: Throughout the entire study, approximately during 24 months
Lactotest 202 - Area under the curve (calculated on 4 hours following lactulose ingestion)
Throughout the entire study, approximately during 24 months
Carbohydrates utilization - Carbohydrate active enzymes (CAZymes)
Time Frame: Throughout the entire study, approximately during 24 months
Saliva enzymatic activities
Throughout the entire study, approximately during 24 months
Nutrient intake
Time Frame: Throughout the entire study, approximately during 24 months
Food diary (daily log of what the volunteer eats and drinks each day)
Throughout the entire study, approximately during 24 months
Dietary habits
Time Frame: Throughout the entire study, approximately during 24 months
Food frequency questionnaire (FFQ) (record the volunteers' usual diet and dietary habits)
Throughout the entire study, approximately during 24 months
Well-being
Time Frame: Throughout the entire study, approximately during 24 months
The short form (36) health survey (SF36) (0 = worse physical and mental health functioning, 100 = best physical and mental health functioning)
Throughout the entire study, approximately during 24 months
Transit - frequency
Time Frame: Throughout the entire study, approximately during 24 months
Questionnaire on stool frequency (record each defecation time)
Throughout the entire study, approximately during 24 months
Transit - type of stool
Time Frame: Throughout the entire study, approximately during 24 months
Bristol stools scale (BSS) (classify the form of feces into 7 categories; type 1 = severe constipation, type 2 = mild constipation, types 3 and 4 = normal, type 5 = lacking fiber, type 6 = mild diarrhea, type 7 = severe diarrhea)
Throughout the entire study, approximately during 24 months
Transit - ease of passage
Time Frame: Throughout the entire study, approximately during 24 months
5-point Likert's scale (1 = very difficult to defecate, 5 = very easy to defecate)
Throughout the entire study, approximately during 24 months
Transit - level of emergency
Time Frame: Throughout the entire study, approximately during 24 months
5-point Likert's scale (1 = very urgent need to defecate, 5 = very nonurgent need to defecate)
Throughout the entire study, approximately during 24 months
Transit - empty feeling
Time Frame: Throughout the entire study, approximately during 24 months
5-point Likert's scale (1 = very nonempty feeling after defecation, 5 = very empty feeling after defecation)
Throughout the entire study, approximately during 24 months

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.
Université Catholique de Louvain

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: Nathalie Delzenne, Prof., Université Catholique de Louvain

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.
July 1, 2023

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.
December 31, 2024

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, 2024

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).
April 17, 2023

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.
July 13, 2023

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.
July 18, 2023

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.
July 18, 2023

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.
July 13, 2023

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.
July 1, 2023

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.
  • MICROBOOST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be shared by the partners from the Consortium agreement.

  • Gut and salivary microbiota composition;
  • Urinary, salivary and fecal metabolites;
  • Visual analogue scales data;
  • Gut microbial functions;
  • Nutrient intake and dietary habits;
  • Well-being;
  • Transit;
  • Concomitant medication;
  • Inclusion/exclusion criteria;
  • Adverse event.

Data will be shared at the end of the study.

IPD Sharing Time Frame

At the end of the study

IPD Sharing Access Criteria

Belonging to the project partner (Consortium agreement)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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