CompletedNot Applicable

Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms

Spain126 participantsStarted 2014-10-22

Plain-language summary

To select among different dietary and clinical conditions the most appropriate to assess the impact of a fermented milk product on gas-related symptoms

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1=FGID group: Subject with body mass index (BMI) between 18.5 and 30.0 kg/m2 (bounds excluded); Subject with a functional gastrointestinal disorder according to ROME III criteria; Subject complaining of excessive intestinal gas evacuation (i.e. flatulence); Subject willing to follow strict dietary instructions; Subject who normally consumes dairy products; * 2=Non-FGID group: Subject with body mass index (BMI) between 18.5 and 30.0 kg/m2 (bounds excluded); Subject with no functional gastrointestinal disorder according to ROME III criteria; Subject with no gastrointestinal disorders according to investigator's medical assessment; Subject willing to follow strict dietary instructions; Subject who normally consumes dairy products Exclusion Criteria: * 1=FGID group: Subject with any disease/disorder which can interfere with the gas collection; Subject with any antecedents of digestive surgery; Subject with any intake of antibiotics in the previous 2 months; Subject with any current use of any medication with potential central nervous system effects (except for chronic treatment with anxiolytics and antidepressants started at least 3 months before inclusion in the study); Subject taking drugs that might modify gastrointestinal function (except for chronic treatment with laxatives, started at least 3 months before inclusion in the study) ; * 2=Non-FGID group: Subject with any disease/disorder which can interfere with the gas collection; Subject with any ant…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in number of gas evacuations per anus

Timeframe: during a 3-day baseline period and during two 3-day periods of controlled diet before and after a 28-day study product consumption period

Change in intestinal gas volume

Timeframe: following a 3-day period of controlled diet before and after a 28- day study product consumption period

Change in intestinal gas composition

Timeframe: following a 3- day period of controlled diet before and after a 28-day study product consumption period

Change in colonic gas volume/segmental distribution

Timeframe: following a 3-day period of controlled diet before and after a 28-day study product consumption period

Gas related symptoms (self-completed questionnaire)

Timeframe: 3 days

Digestive well-being (self-completed questionnaire)

Timeframe: 3 days

Composition of gut microbiota (molecular biology methods)

Trial details

NCT IDNCT02936713

SponsorDanone Global Research & Innovation Center

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-23

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in number of gas evacuations per anus

Timeframe: during a 3-day baseline period and during two 3-day periods of controlled diet before and after a 28-day study product consumption period

Change in intestinal gas volume

Timeframe: following a 3-day period of controlled diet before and after a 28- day study product consumption period

Change in intestinal gas composition

Timeframe: following a 3- day period of controlled diet before and after a 28-day study product consumption period

Change in colonic gas volume/segmental distribution

Timeframe: following a 3-day period of controlled diet before and after a 28-day study product consumption period

Gas related symptoms (self-completed questionnaire)

Timeframe: 3 days

Digestive well-being (self-completed questionnaire)

Timeframe: 3 days

Composition of gut microbiota (molecular biology methods)