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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Subjec

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 Summary: 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.
Sponsor: Danone Research

Current Primary Outcome:

  • Change in number of gas evacuations per anus [ 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 ]
    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 [ Time Frame: following a 3-day period of controlled diet before and after a 28- day study product consumption period ]
    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 [ Time Frame: following a 3- day period of controlled diet before and after a 28-day study product consumption period ]
    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 [ Time Frame: following a 3-day period of controlled diet before and after a 28-day study product consumption period ]
    Ch

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Danone Research

    Dates:
    Date Received: June 12, 2015
    Date Started: October 22, 2014
    Date Completion:
    Last Updated: February 8, 2017
    Last Verified: February 2017