A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms
Primary Purpose
Celiac Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Balanced low FODMAPs /gluten free diet
Balanced gluten free diet
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring FODMAPs diet, micro-macro nutrients intake, IBS (Irritable Bowel Syndrome)
Eligibility Criteria
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)
Sites / Locations
- University of MilanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low FODMAPs /balanced gluten free diet
Balanced gluten free diet
Arm Description
An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.
An expert in nutrition will give a balanced gluten free diet to patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02946827
First Posted
October 18, 2016
Last Updated
October 26, 2016
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT02946827
Brief Title
A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms
Official Title
The Efficacy of a Low FODMAPs (Fermentable Oligo- di- and Monosaccharides and Polyols) Diet in Celiac Patients With Persistent Gastrointestinal Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
FODMAPs diet, micro-macro nutrients intake, IBS (Irritable Bowel Syndrome)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low FODMAPs /balanced gluten free diet
Arm Type
Experimental
Arm Description
An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.
Arm Title
Balanced gluten free diet
Arm Type
Active Comparator
Arm Description
An expert in nutrition will give a balanced gluten free diet to patients.
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced low FODMAPs /gluten free diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced gluten free diet
Primary Outcome Measure Information:
Title
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
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.
Description
Evaluated IBS symptoms are: abdominal pain, bloating, satisfaction with stool consistency, epigastric pain, postprandial fullness, early satiety.
Time Frame
21 days
Title
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.
Time Frame
21 days
Title
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.
Time Frame
21 days
Title
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leda Roncoroni, BS PhD
Phone
+39025503384
Email
leda.roncoroni@unimi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Leda Roncoroni
Email
leda.roncoroni@unimi.it
Facility Information:
Facility Name
University of Milan
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Elli
Email
dottorlucaelli@gmail.com
First Name & Middle Initial & Last Name & Degree
Luca Elli, MD PhD
First Name & Middle Initial & Last Name & Degree
Francesca Ferretti, MD
First Name & Middle Initial & Last Name & Degree
Federica Branchi, MD
First Name & Middle Initial & Last Name & Degree
Vincenza Lombardo, BS
First Name & Middle Initial & Last Name & Degree
Zaira Tuccitto, BS student
12. IPD Sharing Statement
Plan to Share IPD
No
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A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms
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