Developing non-invasive methods to study gut microbiome interactions with nutrition

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

This study is testing a new way to see how what we eat affects our gut health by measuring breath samples from healthy adults before and after meals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Université Catholique de Louvain (Academic / other)
• Locations: 3 sites (Ottignies-Louvain-la-Neuve, Brabant Wallon and 2 other locations)
• Trial ID: NCT05949411 on ClinicalTrials.gov

What this trial studies

This study aims to create and validate a protocol for measuring volatile metabolites in the breath of healthy volunteers aged 18 to 65. Participants will undergo breath analysis during fasting and after consuming standardized meals to explore gut microbiome interactions with nutrition. The study will utilize selected ion flow tube mass spectrometry (SIFT-MS) and microbiome sequencing to analyze gut microbial functions related to metabolite production. The goal is to better understand how nutrition affects gut health and microbiome activity.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18 and 30 who can speak French.

Not a fit: Patients with severe systemic diseases or chronic gastrointestinal disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dietary recommendations and interventions for enhancing gut health.

How similar studies have performed: While the approach of using breath analysis for gut microbiome studies is emerging, this specific methodology is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Ottignies-Louvain-la-Neuve, Brabant Wallon and 2 other locations

• Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN — Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium (Not_yet_recruiting)
• Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain — Woluwe-Saint-Lambert, Brussels, Belgium (Recruiting)
• Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS — Woluwe-Saint-Lambert, Brussels, Belgium (Recruiting)

Study contacts

• Principal investigator: Nathalie Delzenne, Prof. — Université Catholique de Louvain
• Study coordinator: Nathalie Delzenne, Prof.

Conditions Healthy