NCT05949411

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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 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	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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

3 sites across 1 country: Belgium