Metabolic Response of Intestinal Microbiota to Guar Gum Consumption

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Prebiotic

• Registration Number: NCT05195255
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Some components of the diet are not absorbed in the small intestine and pass into the colon, where they may be fermented by the microbiota, releasing gas. A series of recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate to colonic bacteria and change their composition, thereby producing beneficial effects to the host. These products are fermented by bacteria and at initial intake increase gas production; however, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production. Hence, intestinal gas production may serve as an index of microbiota metabolic activity. Gas production may induce gas-related symptoms, such as flatulence, abdominal bloating and distention, and the symptoms improve when the microbiota adapts to the prebiotic and gas production declines. Guar gum is classified as a fiber, but it remains uncertain whether and to what extent it is fermented by colonic microbiota and whether it has prebiotic properties. Aim: to determine the metabolic reaction of intestinal microbiota in response to guar gum consumption, specifically, the extent of initial fermentation and subsequent adaptation.Design: Single-centre, single arm, open label, proof-of-concept study testing the effect of guar gum on microbiota metabolism and adaptation in healthy subjects Intervention: guar gum (8 g/d) will be administered for 18 days. Outcomes: during 4 days immediately before, at the beginning and at the end of the administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) perception of digestive sensations by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-18
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-29
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Exclusion Criteria

• gastrointestinal symptoms
• recent (3 months) antibiotic intake
• change in dietary habits 4 weeks before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Prebiotic	Prebiotic administration

Primary Outcome Measures

Name	Time	Method
Number of daily anal gas evacuations	18 days	Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment

Secondary Outcome Measures

Name	Time	Method
Sensation of flatulence by scales	18 days	Sensation of flatulence measured on a 0-10 scale graded from 0 (no flatulence) to 10 (very intense sensation). Change from beginning of treatment to end of treatment
Sensation of digestive well-being by scales	18 days	Sensation of digestive well-being measured on a -5 to +5 scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation). Change from beginning of treatment to end of treatment.
Microbiota composition by fecal analysis	18 days	Change from beginning of treatment to end of treatment
Sensation of abdominal bloating by scales	18 days	Sensation of abdominal bloating measured on a 0-10 scale graded from 0 (no bloating) to 10 (very intense sensation). Change from beginning of treatment to end of treatment.

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain