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

NCT02936713 | Completed

• 1 other identifier: NU362
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Gastrointestinal Disorders

Keywords

flatulence; gas; probiotics; fermented milk; diet; functional gastrointestinal disorders

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

1=Functional Gastro-Intestinal Disorder (FGID)

EXPERIMENTAL

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=Non-FGID

EXPERIMENTAL

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)

Interventions

Fermented milk product with probiotics (FMPP) OTHER

2 pots of 125g FMPP / day

1=Functional Gastro-Intestinal Disorder (FGID); 2=Non-FGID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• =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;
• =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

You may not qualify if:

• =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

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Hospital Vall d'Hebron - DIGESTIVE SYSTEM RESEARCH UNIT

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Flatulence; Mucopolysaccharidosis IV

Interventions

Cultured Milk Products; Probiotics

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages; Dietary Supplements

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: October 18, 2016
• Study Start: October 22, 2014
• Primary Completion: December 23, 2016
• Study Completion: December 23, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

ES (1)