Clinical trial NCT02210572: Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms
Official title: Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: Intestinal microbiota
Intestinal gas
Dietary intervention
Low-FODMAPs diet
Prebiotics
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

  1. Birth control pill
  2. Intra-uterine device (IUD)
  3. Double barrier methods (such as condoms and spermicide)
  4. 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

Primary outcomes:
measure: Gut microbiota composition
timeFrame: 28 days
Secondary outcomes:
measure: Microbiota activity (intestinal gas production)
timeFrame: 28 days
measure: Digestive symptoms
timeFrame: 28 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
Study officials:
affiliation: Vall d'Hebron Research Institute
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huaman JW, Mego M, Manichanh C, Canellas N, Canueto D, Segurola H, Jansana M, Malagelada C, Accarino A, Vulevic J, Tzortzis G, Gibson G, Saperas E, Guarner F, Azpiroz F. Effects of Prebiotics vs a Diet Low in FODMAPs in Patients With Functional Gut Disorders. Gastroenterology. 2018 Oct;155(4):1004-1007. doi: 10.1053/j.gastro.2018.06.045. Epub 2018 Jun 30.