- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04655495
Impact of a Low-FODMAP Gluten-free Diet on Gut Microbiota and Circulating miRNAs in Celiac Disease Patients (FODMAP2019)
Impact of a Low-FODMAP Gluten-free Diet on Gut Microbiota and Circulating miRNAs in Different Phenotypes of Celiac Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Celiac disease (CD) is a chronic, autoimmune, multisystemic disorder caused by ingestion of gluten contained in wheat. A chronic gluten-free diet (GFD) is the only therapy for CD, however a small subgroup of patients is refractory to a GFD, in fact the pathology does not regress even with a strict diet. The microbiota plays a fundamental role in the CD, in fact, especially intestinal homeostasis requires balanced interactions between the microbiota, food antigens and the host. It is widely recognized that intestinal microbiota plays a role in the initiation and progression of intestinal inflammation in numerous chronic conditions, but recent studies have shown that even the blood microbiota plays a fundamental role in autoimmune diseases. Also microRNAs (miRNAs), RNA sequences of 20-22 non-coding nucleotides that post-transcriptionally regulate gene expression, are molecules of interest in many common diseases and therefore also in CD. Fermentable, Oligo-, Di-, Mono-saccharides And Polyol (FODMAP) are short-chain carbohydrates with poor absorption in the small intestine which increases gas production and intestinal osmolarity, which can trigger gastrointestinal symptoms in sensitive individuals. A diet low in FODMAPs is a new dietary option for the treatment of persistent gastrointestinal symptoms in celiac patients. Evaluating the effect of this type of diet on intestinal microbiota changes and miRNA expression in celiac patients with persistent gastroenterological symptoms and in patients with refractory celiac disease represents an opportunity to understand how this dietary modification could contribute to the development of this disease.
15 patients with refractory celiac disease (RCD) and 15 patients with CD responsive to the GFD between the ages of 21 and 60 will be enrolled. The aim of the research will be: 1) to characterize the intestinal, blood and duodenal microbiota, then to evaluate both the taxonomy of the identified bacteria and their relative abundance 2) to analyse the profile of miRNAs from biopsy and fibroblasts isolated in the first duodenal portion, highlighting any basal deregulation and, for fibroblasts, after treatment with the 33-mer immunogenic peptide 3) quantify and know the composition of the fecal microbiota in celiac patients with persistent symptoms and in refractory celiac patients before (T0) and after (T28) treatment with a low-FODMAP diet. The aim of the study is to observe a diversification of the microbiota pattern of refractory patients vs. normoresponsive celiac patients and to observe a deregulation in the expression of miRNAs, both basally on biopsies and after treatment with the immunogenic peptide in primary fibroblast cultures.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Leda Roncoroni, MS, PhD
- Phone Number: +390255033384
- Email: leda.roncoroni@unimi.it
Study Locations
-
-
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Milan, Italy, 20100
- Recruiting
- Leda Roncoroni
-
Sub-Investigator:
- Vincenza Lombardo, BS
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Principal Investigator:
- Luca Elli, MD, PhD
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Principal Investigator:
- Leda Roncoroni, MS, PhD
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Sub-Investigator:
- Alice Scricciolo, MS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients on a proper gluten-free diet (assessing adherence to the gluten-free diet using the Celiac Dietary Adherence Test (CDAT)
- celiac subjects diagnosed through a positive serological test of anti-endomysium antibodies (EMA) and tissue transglutaminase antibodies (TTG) evaluated through a histological abnormality in duodenal biopsies in accordance with Marsh's modified classification
- refractory celiac disease (CD)
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Subjects who follow special diets: vegetarianism, veganism
- Subjects with psychiatric disorders, diabetes mellitus, autoimmune systemic diseases, previous anaphylactic episodes, systemic disorders
- individual intolerance to disaccharides evaluated through the expired hydrogen test (lactose and fructose)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low FODMAPs /balanced gluten free diet
Dietary Supplement: Balanced low FODMAPs /gluten free diet.
An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.
|
Dietary Supplement: Balanced low FODMAPs /gluten free diet
|
Active Comparator: Balanced gluten free diet
Balanced gluten free diet.
An expert in nutrition will give a balanced gluten free diet to patients.
|
Dietary Supplement: Balanced low FODMAPs /gluten free diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota alpha and beta diversity
Time Frame: 28 days
|
Evaluate both the biodiversity and the relative abundance of haematic, intestinal and duodenal bacteria in the refractory celiac population of type I and II compared to normoresponsive celiac patients
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
miRNAs
Time Frame: 28 days
|
Evaluate the regulation of duodenal miRNAs in RCD patients and compare them with the miRNAs expressed in normoresponsive patients
|
28 days
|
IBS symptoms
Time Frame: 28 days
|
Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced.
Evaluated IBS symptoms are: abdominal pain, bloating, satisfaction with stool consistency, epigastric pain, postprandial fullness, early satiety.
|
28 days
|
SF-36
Time Frame: 28 days
|
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.
|
28 days
|
SCL 90
Time Frame: 28 days
|
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
|
28 days
|
Dietary intake
Time Frame: 28 days
|
Evaluation of the dietary intake in micro and macro-nutrients before and after following the assigned diet through questionnaire.
|
28 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Marasco G, Di Biase AR, Schiumerini R, Eusebi LH, Iughetti L, Ravaioli F, Scaioli E, Colecchia A, Festi D. Gut Microbiota and Celiac Disease. Dig Dis Sci. 2016 Jun;61(6):1461-72. doi: 10.1007/s10620-015-4020-2. Epub 2016 Jan 2.
- Wacklin P, Laurikka P, Lindfors K, Collin P, Salmi T, Lahdeaho ML, Saavalainen P, Maki M, Matto J, Kurppa K, Kaukinen K. Altered duodenal microbiota composition in celiac disease patients suffering from persistent symptoms on a long-term gluten-free diet. Am J Gastroenterol. 2014 Dec;109(12):1933-41. doi: 10.1038/ajg.2014.355. Epub 2014 Nov 18.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- parere 89_2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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