Impact of a Low-FODMAP Gluten-free Diet on Gut Microbiota and Circulating miRNAs in Celiac Disease Patients
FODMAP2019
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
February 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2023
CompletedJanuary 18, 2023
January 1, 2023
11 months
November 17, 2020
January 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microbiota alpha and beta diversity
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 Outcomes (5)
miRNAs
28 days
IBS symptoms
28 days
SF-36
28 days
SCL 90
28 days
Dietary intake
28 days
Study Arms (2)
Low FODMAPs /balanced gluten free diet
EXPERIMENTALDietary Supplement: Balanced low FODMAPs /gluten free diet. An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.
Balanced gluten free diet
ACTIVE COMPARATORBalanced gluten free diet. An expert in nutrition will give a balanced gluten free diet to patients.
Interventions
Dietary Supplement: Balanced low FODMAPs /gluten free diet
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leda Roncoroni
Milan, 20100, Italy
Related Publications (2)
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.
PMID: 26725064RESULTWacklin 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.
PMID: 25403367RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2020
First Posted
December 7, 2020
Study Start
February 6, 2022
Primary Completion
January 9, 2023
Study Completion
January 9, 2023
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share