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

Primary Purpose

Functional Gastrointestinal Disorders

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Bimuno Galacto-oligosaccharide 1.37 g/d

Low- FODMAPs diet

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Intestinal microbiota, Intestinal gas, Dietary intervention, Low-FODMAPs diet, Prebiotics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vall d'Hebron Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bimuno Galacto-oligosaccharide

Low- FODMAPs diet

Arm Description

Dietary intervention

Outcomes

Primary Outcome Measures

Gut microbiota composition

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

Secondary Outcome Measures

Microbiota activity (intestinal gas production)

Intestinal gas evacuation on standardized diet

Digestive symptoms

Digestive sensations measured by scales

Full Information

NCT ID

NCT02210572

First Posted

August 5, 2014

Last Updated

November 27, 2015

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02210572

Brief Title

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

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Gastrointestinal Disorders

Keywords

Intestinal microbiota, Intestinal gas, Dietary intervention, Low-FODMAPs diet, Prebiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bimuno Galacto-oligosaccharide

Arm Type

Experimental

Arm Description

Dietary intervention

Arm Title

Low- FODMAPs diet

Arm Type

Placebo Comparator

Arm Description

Dietary intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Bimuno Galacto-oligosaccharide 1.37 g/d

Intervention Description

Prebiotic versus low-FODMAPs diet

Intervention Type

Dietary Supplement

Intervention Name(s)

Low- FODMAPs diet

Primary Outcome Measure Information:

Title

Gut microbiota composition

Description

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Microbiota activity (intestinal gas production)

Description

Intestinal gas evacuation on standardized diet

Time Frame

28 days

Title

Digestive symptoms

Description

Digestive sensations measured by scales

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Azpiroz, MD

Organizational Affiliation

Vall d'Hebron Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vall d'Hebron Research Institute

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

29964041

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.

Results Reference

derived

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

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