Back to resultsEffect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms (FLATBACK)
Primary Purpose
Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fermented milk product with probiotics (FMPP)
Sponsored by
About this trial
This is an interventional other trial for Functional Gastrointestinal Disorders focused on measuring flatulence, gas, probiotics, fermented milk, diet, functional gastrointestinal disorders
Eligibility Criteria
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
Sites / Locations
- Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1=Functional Gastro-Intestinal Disorder (FGID)
2=Non-FGID
Arm Description
1=FGID study group: 40 evaluable FGID subjects with a functional gastrointestinal disorder (FGID) complaining of excessive gas evacuation per anus (i.e excessive flatulence), aged from 18 to 75 years that will consume a 3-day specific and controlled mild flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product)
2=Non-FGID study group: 60 evaluable non-FGID subjects aged from 18 to 75 years that will consume a 3-day specific controlled high flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product)
Outcomes
Primary Outcome Measures
Change in number of gas evacuations per anus
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.
Change in intestinal gas volume
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.
Change in intestinal gas composition
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.
Change in colonic gas volume/segmental distribution
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.
Gas related symptoms (self-completed questionnaire)
Digestive well-being (self-completed questionnaire)
Composition of gut microbiota (molecular biology methods)
Bowel function (self-completed questionnaire; bristol stool scale)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02936713
Brief Title
Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms
Acronym
FLATBACK
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 22, 2014 (Actual)
Primary Completion Date
December 23, 2016 (Actual)
Study Completion Date
December 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
Keywords
flatulence, gas, probiotics, fermented milk, diet, functional gastrointestinal disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1=Functional Gastro-Intestinal Disorder (FGID)
Arm Type
Experimental
Arm Description
1=FGID study group: 40 evaluable FGID subjects with a functional gastrointestinal disorder (FGID) complaining of excessive gas evacuation per anus (i.e excessive flatulence), aged from 18 to 75 years that will consume a 3-day specific and controlled mild flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product)
Arm Title
2=Non-FGID
Arm Type
Experimental
Arm Description
2=Non-FGID study group: 60 evaluable non-FGID subjects aged from 18 to 75 years that will consume a 3-day specific controlled high flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product)
Intervention Type
Other
Intervention Name(s)
Fermented milk product with probiotics (FMPP)
Intervention Description
2 pots of 125g FMPP / day
Primary Outcome Measure Information:
Title
Change in number of gas evacuations per anus
Description
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.
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
Title
Change in intestinal gas volume
Description
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.
Time Frame
following a 3-day period of controlled diet before and after a 28- day study product consumption period
Title
Change in intestinal gas composition
Description
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.
Time Frame
following a 3- day period of controlled diet before and after a 28-day study product consumption period
Title
Change in colonic gas volume/segmental distribution
Description
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.
Time Frame
following a 3-day period of controlled diet before and after a 28-day study product consumption period
Title
Gas related symptoms (self-completed questionnaire)
Time Frame
3 days
Title
Digestive well-being (self-completed questionnaire)
Time Frame
3 days
Title
Composition of gut microbiota (molecular biology methods)
Time Frame
5 days
Title
Bowel function (self-completed questionnaire; bristol stool scale)
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
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Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms
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