NCT02618239

Brief Summary

Non-absorbable, fermentable residues in the diet increase intestinal gas production and induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however, prebiotics, which are also fermented by colonic bacteria have been shown to improve this type of symptoms. The aim is to demonstrate changes in metabolic activity of gut microbiota and colonic biomass induced by prebiotics. Healthy subjects (n=20) will be administered a prebiotic (Galacto-oligo-saccharide; 2.8 g/d) for 3 weeks; they will also receive a standard diet during three days. The following outcomes will be measured immediately before, at the beginning and at the end of the treatment: a) number of gas evacuations during daytime for 2 days on the standard diet, by means of an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test meal, by means of a barostat; c) microbiota composition by fecal analysis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

December 1, 2015

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

November 11, 2015

Last Update Submit

November 26, 2015

Conditions

Healthy

Keywords

intestinal gasHealthy subjectsmicrobiotaprebiotics

Outcome Measures

Primary Outcomes (1)

  • Number of daily anal gas evacuations

    Change from beginning of treatment (mean of days 2 and 3) to end of treatment (mean of days 20 and 21)

Secondary Outcomes (1)

  • Volume of anal gas evacuation

    Change from beginning of treatment (day 3) to end of treatment (day 21)

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Bimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks

Dietary Supplement: Bimuno Galacto-oligo-saccharide

Interventions

Bimuno Galacto-oligo-saccharideDIETARY_SUPPLEMENT
Healthy subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • gastrointestinal symptoms
  • recent (3 months) antibiotic intake
  • recent (3 months) change of diet
  • recent (3 months) gastroenteritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mego M, Manichanh C, Accarino A, Campos D, Pozuelo M, Varela E, Vulevic J, Tzortzis G, Gibson G, Guarner F, Azpiroz F. Metabolic adaptation of colonic microbiota to galactooligosaccharides: a proof-of-concept-study. Aliment Pharmacol Ther. 2017 Mar;45(5):670-680. doi: 10.1111/apt.13931. Epub 2017 Jan 12.

    PMID: 28078750DERIVED

Study Officials

  • Fernando Azpiroz, MD

    Vall d'Hebron Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2015

First Posted

December 1, 2015

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

December 1, 2015

Record last verified: 2013-11