Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500754
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Persistent Villous Atrophy in Celiac Disease Patients Following an Intentionally Strict Gluten-free Diet
Sponsor:
Hospital Mutua de Terrassa
Organization:
Hospital Mutua de Terrassa
Study Overview
Official Title:
Study of the Causes and Consequences of Persistent Villous Atrophy Despite an Intentionally Strict Gluten-free Diet in Celiac Disease Patients - Effect of an Ultra-strict Gluten-free Diet on Persistent Villous Atrophy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADER2
Brief Summary:
Celiac disease CD is an immune-mediated disease characterized by small intestinal inflammation from gluten ingestion a group of proteins present in various cereals including wheat rye barley spelt and kamut CD is the most common chronic gastrointestinal disease and one of the most common autoimmune disorders estimated to affect 04-17 of the general population Currently a strict lifelong gluten-free diet GFD is the only available treatment to avoid the inappropriate inflammatory response and prevent the shortening of the villi lining the small intestine villous atrophy However a significant proportion of CD patients ranging from 4 to 79 show persistent villous atrophy despite following an intentional GFD The causative factors and the clinical consequences of persistent villous atrophy in CD patients are not well known yet but might resemble untreated CD long-term complications
Interestingly in the precedent study CADER persistent villous atrophy was found to be more present in patients diagnosed at an older age 65 of CD patients diagnosed after 30 years of age than in younger patients Moreover unintentional exposure to gluten was found in 70 of the cases The causative factors of this hypersensitivity to small amounts of gluten present in older patients are unknown The intestinal microbiota and age-related epigenetic changes may help maintaining the dysregulation of the immune response causing older patients to be hypersensitive to small amounts of gluten
The aim of this study CADER2 is to identify the immunological and clinical consequences of persistent villous atrophy in CD and study whether changes in the intestinal microbiome and age-related epigenetic modifications may contribute to it Last the investigators want to assess if an ultra-strict GFD can be a viable and effective alternative to treat this subset of CD patients In order to achieve these objectives the study includes 2 phases 1 Cross-sectional study to assess the causes and the clinical consequences of persistent villous atrophy in CD patients and 2 Longitudinal study to evaluate the potential therapeutic effect of an ultra-strict GFD on persistent villous atrophy and its subtle clinical manifestations
The investigators hypothesize that persistent villous atrophy in CD patients despite an intentional GFD is associated with chronic low-grade inflammation and increased circulating cytokines in blood potentially leading to cognitive deficits fatigue anxiety depression malnutrition sarcopenia and osteoporosis The intestinal microbiota and age-related epigenetic changes may help to maintain the dysregulation of the immune response causing patients to be hypersensitive to small amounts of gluten This subset of CD patient could highly benefit from an ultra-strict GFD
To date six centers have been recruited Hospital Universitari Mutua Terrassa Barcelona Hospital Clínico San Carlos Madrid Hospital Fundación Jiménez Díaz Madrid Hospital Universitario de La Princesa Madrid Hospital Universitario Ramón y Cajal Madrid and Hospital Universitario Virgen Macarena Sevilla Digestive endocrine nutritional and clinical psychology experts will be involved in the monitoring of the patients Microbiome analysis will be performed at the Genomics Unit Microbiota Laboratory LABMIC of the IdISSC Madrid The methylation studies age-related epigenetic modifications will be hired externally
Overall the results of this study CADER2 may help identify new therapeutic strategies as well as improve the management of chronicity and care of CD patients who do not respond to the current treatment Furthermore it will contribute to a deeper understanding of the pathophysiological relationships between diet microbiome genetics and immunology in CD
Interestingly in the precedent study CADER persistent villous atrophy was found to be more present in patients diagnosed at an older age 65 of CD patients diagnosed after 30 years of age than in younger patients Moreover unintentional exposure to gluten was found in 70 of the cases The causative factors of this hypersensitivity to small amounts of gluten present in older patients are unknown The intestinal microbiota and age-related epigenetic changes may help maintaining the dysregulation of the immune response causing older patients to be hypersensitive to small amounts of gluten
The aim of this study CADER2 is to identify the immunological and clinical consequences of persistent villous atrophy in CD and study whether changes in the intestinal microbiome and age-related epigenetic modifications may contribute to it Last the investigators want to assess if an ultra-strict GFD can be a viable and effective alternative to treat this subset of CD patients In order to achieve these objectives the study includes 2 phases 1 Cross-sectional study to assess the causes and the clinical consequences of persistent villous atrophy in CD patients and 2 Longitudinal study to evaluate the potential therapeutic effect of an ultra-strict GFD on persistent villous atrophy and its subtle clinical manifestations
The investigators hypothesize that persistent villous atrophy in CD patients despite an intentional GFD is associated with chronic low-grade inflammation and increased circulating cytokines in blood potentially leading to cognitive deficits fatigue anxiety depression malnutrition sarcopenia and osteoporosis The intestinal microbiota and age-related epigenetic changes may help to maintain the dysregulation of the immune response causing patients to be hypersensitive to small amounts of gluten This subset of CD patient could highly benefit from an ultra-strict GFD
To date six centers have been recruited Hospital Universitari Mutua Terrassa Barcelona Hospital Clínico San Carlos Madrid Hospital Fundación Jiménez Díaz Madrid Hospital Universitario de La Princesa Madrid Hospital Universitario Ramón y Cajal Madrid and Hospital Universitario Virgen Macarena Sevilla Digestive endocrine nutritional and clinical psychology experts will be involved in the monitoring of the patients Microbiome analysis will be performed at the Genomics Unit Microbiota Laboratory LABMIC of the IdISSC Madrid The methylation studies age-related epigenetic modifications will be hired externally
Overall the results of this study CADER2 may help identify new therapeutic strategies as well as improve the management of chronicity and care of CD patients who do not respond to the current treatment Furthermore it will contribute to a deeper understanding of the pathophysiological relationships between diet microbiome genetics and immunology in CD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None