NCT02210572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

August 1, 2014

Enrollment Period

9 months

First QC Date

August 5, 2014

Last Update Submit

November 27, 2015

Conditions

Functional Gastrointestinal Disorders

Keywords

Intestinal microbiotaIntestinal gasDietary interventionLow-FODMAPs dietPrebiotics

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition

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

    28 days

Secondary Outcomes (2)

  • Microbiota activity (intestinal gas production)

    28 days

  • Digestive symptoms

    28 days

Study Arms (2)

Bimuno Galacto-oligosaccharide

EXPERIMENTAL

Dietary intervention

Dietary Supplement: Bimuno Galacto-oligosaccharide 1.37 g/d

Low- FODMAPs diet

PLACEBO COMPARATOR

Dietary intervention

Dietary Supplement: Low- FODMAPs diet

Interventions

Bimuno Galacto-oligosaccharide 1.37 g/dDIETARY_SUPPLEMENT

Prebiotic versus low-FODMAPs diet

Bimuno Galacto-oligosaccharide
Low- FODMAPs dietDIETARY_SUPPLEMENT
Low- FODMAPs diet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Functional digestive disorder with flatulence
  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron Research Institute

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29964041DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Fernando Azpiroz, MD

    Vall d'Hebron Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

August 1, 2014

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

November 30, 2015

Record last verified: 2014-08

Locations

ES(1)