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Metabolic Response of Intestinal Microbiota to Guar Gum Consumption

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ClinicalTrials.gov Identifier: NCT05195255
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Prebiotic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prebiotic Properties of Phenolic Compounds
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : April 29, 2022

Arm Intervention/treatment
Experimental: Healthy subjects
Prebiotic administration
Dietary Supplement: Prebiotic
Guar gum (8 g/d) will be administered for 18 days




Primary Outcome Measures :
  1. Number of daily anal gas evacuations [ Time Frame: 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 :
  1. Microbiota composition by fecal analysis [ Time Frame: 18 days ]
    Change from beginning of treatment to end of treatment

  2. Sensation of flatulence by scales [ Time Frame: 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

  3. Sensation of abdominal bloating by scales [ Time Frame: 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.

  4. Sensation of digestive well-being by scales [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195255


Contacts
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Contact: Fernando Azpiroz, MD +34932746259 azpiroz.fernando@gmail.com
Contact: Gloria Santaliestra +34932746259 gsantaliestra@vhebron.net

Locations
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Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Gloria Santaliestra    932746259    gsantaliestra@vhebron.net   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT05195255    
Other Study ID Numbers: PR(AG)33/2021B
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
intestinal gas
healthy subjects
microbiota
prebiotic