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

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

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

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Other: Fermented milk product with probiotics (FMPP)

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1=Functional Gastro-Intestinal Disorder (FGID); 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)	Other: Fermented milk product with probiotics (FMPP); 2 pots of 125g FMPP / day
Experimental: 2=Non-FGID; 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)	Other: Fermented milk product with probiotics (FMPP); 2 pots of 125g FMPP / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Gas related symptoms (self-completed questionnaire)		3 days
Digestive well-being (self-completed questionnaire)		3 days
Composition of gut microbiota (molecular biology methods)		5 days
Bowel function (self-completed questionnaire; bristol stool scale)		3 days

Collaborators and Investigators

• Sponsor: Danone Research

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2014
• Primary Completion (Actual): December 23, 2016
• Study Completion (Actual): December 23, 2016

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: probiotics; diet; gas; functional gastrointestinal disorders; flatulence; fermented milk
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: NU362