Clinical trial NCT02936713: Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms
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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: flatulence
gas
probiotics
fermented milk
diet
functional gastrointestinal disorders
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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
measure: Change in intestinal gas volume
timeFrame: following a 3-day period of controlled diet before and after a 28- day study product consumption period
measure: Change in intestinal gas composition
timeFrame: following a 3- day period of controlled diet before and after a 28-day study product consumption period
measure: 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
measure: Gas related symptoms (self-completed questionnaire)
timeFrame: 3 days
measure: Digestive well-being (self-completed questionnaire)
timeFrame: 3 days
measure: Composition of gut microbiota (molecular biology methods)
timeFrame: 5 days
measure: Bowel function (self-completed questionnaire; bristol stool scale)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT
Study officials:
References: