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

Functional Gastrointestinal Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936713
• Other study ID #: NU362
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: February 8, 2017
• Start date: October 22, 2014
• Est. completion date: December 23, 2016

Study information

• Verified date: February 2017
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 23, 2016
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Other:
• Fermented milk product with probiotics (FMPP)
2 pots of 125g FMPP / day

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	following a 3-day period of controlled diet before and after a 28- day study product consumption period
Primary	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.	following a 3- day period of controlled diet before and after a 28-day study product consumption period
Primary	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.	following a 3-day period of controlled diet before and after a 28-day study product consumption period
Primary	Gas related symptoms (self-completed questionnaire)		3 days
Primary	Digestive well-being (self-completed questionnaire)		3 days
Primary	Composition of gut microbiota (molecular biology methods)		5 days
Primary	Bowel function (self-completed questionnaire; bristol stool scale)		3 days