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CompletedNCT02618239Updated Dec 1, 2015

Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

An interventional study of Bimuno Galacto-oligo-saccharide in Healthy, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-01.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Healthy

Keywords

  • intestinal gas
  • Healthy subjects
  • microbiota
  • prebiotics
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In context

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

-

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Healthy subjects

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

    Dietary Supplement: Bimuno Galacto-oligo-saccharide

Interventions

  • Dietary supplementBimuno Galacto-oligo-saccharide
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What researchers measure

Primary outcomes

  1. Number of daily anal gas evacuations

    Time frame: 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

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28078750 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02618239
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Responsible party
Sponsor
First posted
Dec 1, 2015
Start date
Nov 2013
Primary completion
Apr 2014
Completion
May 2014
Last update
Dec 1, 2015

Study contacts

Fernando Azpiroz, MD
principal investigator · Vall d'Hebron Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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