Clinical trial NCT05949411: Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions
Official title: Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


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.

Primary outcomes:
measure: Exhaled volatile compounds
timeFrame: Throughout the entire study, approximately during 24 months
Secondary outcomes:
measure: Gut microbiota
timeFrame: Throughout the entire study, approximately during 24 months
measure: Salivary microbiota
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - discomfort
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - nausea
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - bloating
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - flatulences
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - gastrointestinal reflux
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - cramps
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - rumbling
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gastrointestinal symptom - burps
timeFrame: Throughout the entire study, approximately during 24 months
measure: Gut microbiota metabolic capacity
timeFrame: Throughout the entire study, approximately during 24 months
measure: Exhaled hydrogen (H2)
timeFrame: Throughout the entire study, approximately during 24 months
measure: Exhaled methane (CH4)
timeFrame: Throughout the entire study, approximately during 24 months
measure: Exhaled carbon dioxide (CO2)
timeFrame: Throughout the entire study, approximately during 24 months
measure: Carbohydrates utilization - Carbohydrate active enzymes (CAZymes)
timeFrame: Throughout the entire study, approximately during 24 months
measure: Nutrient intake
timeFrame: Throughout the entire study, approximately during 24 months
measure: Dietary habits
timeFrame: Throughout the entire study, approximately during 24 months
measure: Well-being
timeFrame: Throughout the entire study, approximately during 24 months
measure: Transit - frequency
timeFrame: Throughout the entire study, approximately during 24 months
measure: Transit - type of stool
timeFrame: Throughout the entire study, approximately during 24 months
measure: Transit - ease of passage
timeFrame: Throughout the entire study, approximately during 24 months
measure: Transit - level of emergency
timeFrame: Throughout the entire study, approximately during 24 months
measure: Transit - empty feeling
timeFrame: Throughout the entire study, approximately during 24 months
Other outcomes:
Locations:
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN
state: Brabant Wallon
city: Woluwe-Saint-Lambert
country: Belgium
facility: Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain
state: Brussels
city: Woluwe-Saint-Lambert
country: Belgium
facility: Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS
state: Brussels
Study officials:
affiliation: Université Catholique de Louvain
name: Nathalie Delzenne, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neyrinck AM, Rodriguez J, Zhang Z, Nazare JA, Bindels LB, Cani PD, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Breath volatile metabolome reveals the impact of dietary fibres on the gut microbiota: Proof of concept in healthy volunteers. EBioMedicine. 2022 Jun;80:104051. doi: 10.1016/j.ebiom.2022.104051. Epub 2022 May 10.
citation: Neyrinck AM, Rodriguez J, Zhang Z, Seethaler B, Mailleux F, Vercammen J, Bindels LB, Cani PD, Nazare JA, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Noninvasive monitoring of fibre fermentation in healthy volunteers by analyzing breath volatile metabolites: lessons from the FiberTAG intervention study. Gut Microbes. 2021 Jan-Dec;13(1):1-16. doi: 10.1080/19490976.2020.1862028.