MedDataX Logo

A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

NCT ID: NCT02946827

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to intestinal distension.

The focus of the study is to evaluate if in celiac patients with persistent abdominal symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms. Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk of nutritional inadequacy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Celiac Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

FODMAPs diet micro-macro nutrients intake IBS (Irritable Bowel Syndrome)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low FODMAPs /balanced gluten free diet

An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.

Group Type EXPERIMENTAL

Balanced low FODMAPs /gluten free diet

Intervention Type DIETARY_SUPPLEMENT

Balanced gluten free diet

An expert in nutrition will give a balanced gluten free diet to patients.

Group Type ACTIVE_COMPARATOR

Balanced gluten free diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Balanced low FODMAPs /gluten free diet

Intervention Type DIETARY_SUPPLEMENT

Balanced gluten free diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Celiac patients assessed through positive serology and histology
* functional patients according IBS Roma III criteria
* subjects with VAS\>5

Exclusion Criteria

* refractory celiac disease
* disaccharide intolerance (fructose an lactose breath test)
* abdominal surgery
* comorbidity
* patients recruited in other clinical trials
* positive patients at lactulose breath test (SIBO)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leda Roncoroni

BS PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Milan

Milan, Milan, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Leda Roncoroni, BS PhD

Role: CONTACT

Phone: +39025503384

Email: [email protected]

Leda Roncoroni

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luca Elli

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016/464

Identifier Type: -

Identifier Source: org_study_id