NCT03644602

Brief Summary

Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Patients with Inflammatory Bowel Diseases (IBD) and celiac disease (CD) can experience functional gastrointestinal symptoms not related to inflammation, but data about the use of low FODMAPs diet in these settings are still scarce. The aim of the present study was to evaluate the usefulness of a low FODMAPs diet in patients with IBS, non-active IBD and CD on strict gluten-free diet (GFD). A low FODMAPs diet could be a valid option to contrast abdominal symptoms in patients with IBS, non-active IBD and CD on GFD, thus improving the quality of life and the social relations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

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

July 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 4, 2017

Last Update Submit

August 22, 2018

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeCoeliac Disease

Keywords

low FODMAPs dietAdherenceInflammatory Bowel DiseasesIrritable Bowel SyndromeCoeliac Disease

Outcome Measures

Primary Outcomes (1)

  • Improvement of IBS-SSS after 3 months

    to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission. Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaire on quality of life and symptoms (IBS-SSS). The questionnaire was re-administered after 1 month and 3 months of low FODMAPs diet.

    1 month and 3 months

Secondary Outcomes (1)

  • Improvement of SF-36 after 3 months

    1 month and 3 months

Study Arms (3)

IBD patients

ACTIVE COMPARATOR

All subjects with Crohn's disease in clinical remission (defined in the presence of a Crohn's Disease Activity Index, CDAI \<150), and with Ulcerative colitis in clinical remission (defined in the presence of \<3 evacuations / day without blood, in the absence of endoscopic alterations) received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months.

Dietary Supplement: low FODMAPs diet

Coeliac patients

ACTIVE COMPARATOR

Celiac patients on a gluten free diet for at least one year received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months.

Dietary Supplement: low FODMAPs diet

IBS patients

ACTIVE COMPARATOR

Patients with Irritable Bowel Syndrome received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months.

Dietary Supplement: low FODMAPs diet

Interventions

low FODMAPs dietDIETARY_SUPPLEMENT

Low FODMAPs diet was a diet containing low amount of poorly absorbed short-chain carbohydrates (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols)

Coeliac patientsIBD patientsIBS patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • IBS patients
  • IBD patients in remission
  • Coeliac patients on gluten free diet

You may not qualify if:

  • Active IBD
  • Coeliac patients non compliant to gluten free diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aou Federico Ii

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeCeliac Disease

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic DiseasesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Elimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Fabiana Castiglione

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

August 23, 2018

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)