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Completed

NCT Number: NCT02936713

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

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

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Key information

Conditions

Functional Gastrointestinal Disorders Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Digestive System Diseases Flatulence Gastrointestinal Diseases Genetic Diseases, Inborn Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis IV Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT

Barcelona, 08035, Spain

About this study

To select among different dietary (mild or high flatulogenic diet) and clinical conditions (FGID or non-FGID population) as well as different measured parameters (self-completed questionnaires assessing gas related symptoms, digestive well-being and bowel functions, gas volume distribution in the colon by MRI, volume and composition of gas collected per anus and frequency of gas evacuations per anus), the most appropriate to assess the impact of a fermented milk product on gas-related symptoms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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; Subject taking drugs that might modify gastrointestinal function

Treatment and study plan

Fermented milk product with probiotics (FMPP)

Other

2 pots of 125g FMPP / day

Primary outcomes

  1. Change in number of gas evacuations per anus

    Time frame: 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 number of gas evacuations per anus: number of events will be recorded daily using a gas event counter, 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.

  2. Change in intestinal gas volume

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

    Change in intestinal gas volume: gas volume evacuated per anus will be continuously collected and measured every 15 minutes during 4 hours by a specific device, at the time of a standardized breakfast and following a 3-day period of controlled diet before and after a 28- day study product consumption period.

  3. Change in intestinal gas composition

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

    Change in intestinal gas composition: amount of different types of gas (H2, CO2, CH4, O2, N2, H2S, mercaptans) from the 4-hours intestinal gas collection sample will be determined by gas chromatography following a 3- day period of controlled diet before and after a 28-day study product consumption period.

  4. Change in colonic gas volume/segmental distribution

    Time frame: 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: total gas volume and distribution in the different regions of the colon (ascending, transverse, descending, sigmoid/rectum) will be determined using intestinal MRI following a 3-day period of controlled diet before and after a 28-day study product consumption period.

  5. Gas related symptoms (self-completed questionnaire)

    Time frame: 3 days

  6. Digestive well-being (self-completed questionnaire)

    Time frame: 3 days

  7. Composition of gut microbiota (molecular biology methods)

    Time frame: 5 days

  8. Bowel function (self-completed questionnaire; bristol stool scale)

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Exploratory Study Aiming at Assessing the Impact of Specific and Controlled Diets Combined With a Fermented Milk Product on Gas-related Symptoms and Associated Measurements in FGID and Non-FGID Subjects

Acronym: FLATBACK

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2016
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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