A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

Celiac Disease Clinical Trial

Official title:

The Efficacy of a Low FODMAPs (Fermentable Oligo- di- and Monosaccharides and Polyols) Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02946827
• Other study ID #: 2016/464
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 26, 2016
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Leda Roncoroni, BS PhD
• Phone: +39025503384
• Email: leda.roncoroni[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Dietary Supplement:
• Balanced low FODMAPs /gluten free diet

• Balanced gluten free diet

Locations

Country	Name	City	State
Italy	University of Milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.		21 days	No
Secondary	Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.	Evaluated IBS symptoms are: abdominal pain, bloating, satisfaction with stool consistency, epigastric pain, postprandial fullness, early satiety.	21 days	No
Secondary	Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.		21 days	No
Secondary	Improvement of psychological problems and symptoms of psychopathology through the symptom checklist 90 R (SCL 90 R) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.		21 days	No
Secondary	Evaluation of the dietary intake in micro and macro-nutrients before and after a Low FODMAP diet or a balanced Gluten Free diet through questionnaire.		21 days	No