HealthyNCT02618239
Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
A study testing Bimuno Galacto-oligo-saccharide in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bimuno Galacto-oligo-saccharide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- gastrointestinal symptoms
- recent (3 months) antibiotic intake
- recent (3 months) change of diet
- recent (3 months) gastroenteritis
About this study
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.
- Conditions
- Healthy
- Being tested
- Bimuno Galacto-oligo-saccharide
- Keywords
- intestinal gas, Healthy subjects, microbiota, prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimuno Galacto-oligo-saccharideDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Bimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks Receives: Dietary Supplement: Bimuno Galacto-oligo-saccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of daily anal gas evacuations
Measured: 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
Measured: Change from beginning of treatment (day 3) to end of treatment (day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Azpiroz, MD, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618239
- Sponsor's protocol ID
- PR(AG)296/2013
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2015
- Last updated
- 1 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
- ClinicalTrials.gov ID
- NCT02618239
- Acronym / sponsor ID
- PR(AG)296/2013
- Conditions
- Healthy
- Keywords
- intestinal gas, Healthy subjects, microbiota, prebiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Dietary Supplement: Bimuno Galacto-oligo-saccharideBimuno Galacto-oligo-saccharide administration 2.7 g/d x 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- gastrointestinal symptoms
- recent (3 months) antibiotic intake
- recent (3 months) change of diet
- recent (3 months) gastroenteritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bimuno Galacto-oligo-saccharide | Dietary supplement | Healthy subjects |
Primary outcome
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)
1 secondary outcome
Volume of anal gas evacuation
Time frame: Change from beginning of treatment (day 3) to end of treatment (day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
- Derived from this study: PubMed 28078750Mego 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Azpiroz, MD principal investigator
Hospital Universitari Vall d'Hebron Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Bimuno Galacto-oligo-saccharide in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.