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

NCT05949411 | Unknown

• 1 other identifier: MICROBOOST
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Exhaled volatile compounds

  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 Outcomes (23)

• Gut microbiota

  Throughout the entire study, approximately during 24 months

• Salivary microbiota

  Throughout the entire study, approximately during 24 months

• Gastrointestinal symptom - discomfort

  Throughout the entire study, approximately during 24 months

• Gastrointestinal symptom - nausea

  Throughout the entire study, approximately during 24 months

• Gastrointestinal symptom - bloating

  Throughout the entire study, approximately during 24 months

Study Arms (5)

Screening

OTHER

D-42 to D-7

Other: Screening visit

Lactulose

OTHER

D0

Other: Lactulose test

Meal 1

OTHER

D14+/-7

Other: Administration of standardized meals with characterized dietary fiber content

Meal 2

OTHER

D16+/-7

Other: Administration of standardized meals with characterized dietary fiber content

Meal 3

OTHER

D18+/-7

Other: Administration of standardized meals with characterized dietary fiber content

Interventions

Screening visit OTHER

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.

Screening

Lactulose test OTHER

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.

Lactulose

Administration of standardized meals with characterized dietary fiber content OTHER

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.

Meal 1; Meal 2; Meal 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (3)

Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN

Ottignies-Louvain-la-Neuve, Brabant Wallon, 1348, Belgium

NOT YET RECRUITING

Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

RECRUITING

Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

RECRUITING

Related Publications (2)

• 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.

  PMID: 35561452 BACKGROUND

• 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.

  PMID: 33461385 BACKGROUND

Study Officials

• Nathalie Delzenne, Prof.

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Delzenne, Prof.

CONTACT

0032 2 764 73 69; nathalie.delzenne@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: July 18, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study
• Access Criteria: Belonging to the project partner (Consortium agreement)

Locations

BE (3)