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OpenTrials
Completed

NCT Number: NCT02210572

Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms

It has been shown that patients complaining of gas-related symptoms significantly improve on a diet low in fermentable residues. However, other studies suggest that some non-absorbable, fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce beneficial effects to the host, including improvement of abdominal symptoms. The aim of the study is to compare the effects of a diet low in fermentable residues versus a diet suplemented with prebiotics on intestinal microbiota composition, microbiota activity (intestinal gas production) and digestive symptoms.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Functional digestive disorder with flatulence
  • Women and men between the ages of 18 and 80 years (bounds included at the inclusion visit).
  • Normal body weight or with overweight (body mass index between 18.0 and 30.0 kg/m2 (bounds included)).
  • Women of childbearing potential should be using or complying with one of the medically approved methods of contraception such as, but not exclusively, one of the following:
  • Birth control pill
  • Intra-uterine device (IUD)
  • Double barrier methods (such as condoms and spermicide)
  • Abstinence
  • Willing to follow strict dietary instructions for the duration of the study
  • Able to communicate well with the investigator and to comply with the requirements for the study.

Exclusion criteria

  • Significant illness other than functional bowel disorders
  • Disease/disorders which can interfere with the collection of the gas (hemorrhoids,..etc)
  • Antecedents of digestive surgery, excluding appendicectomy
  • Intake of antibiotics in the month (within 30 days) preceding the inclusion visit.
  • Current use of any medications with potential central nervous system effects as judged by the investigator (including but not limited to antidepressants, anxiolytics, opiate pain medications)
  • Taking drugs that might modify gastrointestinal function
  • Change of dietary habits within the preceding 4 weeks (for instance start of a diet high in fiber) or planned change (For example to start a diet) during the period of the study

Treatment and study plan

Bimuno Galacto-oligosaccharide 1.37 g/d

Dietary Supplement

Prebiotic versus low-FODMAPs diet

Low- FODMAPs diet

Dietary Supplement

Primary outcomes

  1. Gut microbiota composition

    Time frame: 28 days

    Effect of treatment on the response of microbiota to 3-day challenge diet

Secondary outcomes

  1. Microbiota activity (intestinal gas production)

    Time frame: 28 days

    Intestinal gas evacuation on standardized diet

  2. Digestive symptoms

    Time frame: 28 days

    Digestive sensations measured by scales

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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