Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249763
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-31
Brief Title:
Effects of Gluten Free Diet in Ulcerative Colitis
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Effects of Dietary Gluten on Gastrointestinal Symptoms in Ulcerative Colitis a Randomised Crossover Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet The main questions the project aims to answer are
What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis
What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis
What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms
During two study periods of one week each participants will be eating gluten free supplemented with daily granola bars without and with high gluten content respectively During each active week participants are asked to
Eat gluten free and two daily granola bars delivered by the research team
Collect blood stool and urine samples
Answer questionnaires about their symptoms disease course habitual lifestyle and compliance to the protocol
What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis
What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis
What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms
During two study periods of one week each participants will be eating gluten free supplemented with daily granola bars without and with high gluten content respectively During each active week participants are asked to
Eat gluten free and two daily granola bars delivered by the research team
Collect blood stool and urine samples
Answer questionnaires about their symptoms disease course habitual lifestyle and compliance to the protocol
Detailed Description:
Introduction To meet the growing demand for lifestyle recommendations among patients Ulcerative Colitis UC for managing their symptoms and wellbeing this study aims to evaluate the use of the gluten free diet in the management of UC Exposure to gluten can activate pro-inflammatory signals in the epithelium that induce mucosal damage and the protein has previously been associated with disease activity in inflammatory bowel disease including UC A suggested pathway for the interaction between disease course and gluten intake is via mucosal damage followed by a flow of pathogens across the intestinal barrier
To our knowledge the effect of gluten on UC disease course is not fully understood and clinical characteristics of patients benefitting from the gluten free diet has not yet been studied To the patients fatigue and pain from the gastrointestinal tract are the most burdensome symptoms of UC affecting life quality and restricting everyday activities for the patients Hence this study aims to evaluate the effects of dietary gluten in the management of gastrointestinal symptoms and fatigue in UC and to identify clinical characteristics of patients with UC benefitting from eating gluten free
Design In this crossover randomized trial the outcomes will be assessed after a one-week period of a high-gluten diet and a one-week period of a gluten free diet Participants and study personnel will be blinded to the dietary intake by granola bars supplementing a complete gluten free diet The intake of dietary fibres and fructans will be controlled and monitored and controlled for
Setting Participants will be recruited from the outpatient clinics for Gastrointestinal Diseases at Hospital Sønderjylland Hospital of Southern Jutland in the city of Aabenraa from from January to May 2024 Data collection will be completed in 2024
Clinical data consist of personal data patient-reported data on disease activity gastrointestinal symptoms fatigue level health related quality of life and dietary intake biomarkers in blood urine and faeces and protocol compliance measures Information registered by clinicians and technicians will be transferred from paper format to electronic format using either double entry of data or automated forms processing
Biologic material consist of blood faeces and urine samples All data are treated confidentially and stored according to the Danish Data Protection Regulation and Data Protection Law
Sample size considerations Sample size estimation was based on a 100 difference in the gastrointestinal symptoms score with a standard deviation SD of 180 which at a 5 significance level two-sided and with 80 statistical power would require a sample size of 28 completing participants Consequently it was decided to aim for a total sample size of 30 participants corresponding to a statistical power of 84
Project organization The project is part of a PhD doctor of philosophy study Collaborators are specialists from the gastrointestinal biochemical and microbiology departments involved in the project and professors in biostatistics and food sciences
The study is approved by the local Ethics Committee S-20210174 and the local Data Agency 2239335 The study findings will be disseminated in peer-reviewed journals via patient associations and presented at national and international conferences
To our knowledge the effect of gluten on UC disease course is not fully understood and clinical characteristics of patients benefitting from the gluten free diet has not yet been studied To the patients fatigue and pain from the gastrointestinal tract are the most burdensome symptoms of UC affecting life quality and restricting everyday activities for the patients Hence this study aims to evaluate the effects of dietary gluten in the management of gastrointestinal symptoms and fatigue in UC and to identify clinical characteristics of patients with UC benefitting from eating gluten free
Design In this crossover randomized trial the outcomes will be assessed after a one-week period of a high-gluten diet and a one-week period of a gluten free diet Participants and study personnel will be blinded to the dietary intake by granola bars supplementing a complete gluten free diet The intake of dietary fibres and fructans will be controlled and monitored and controlled for
Setting Participants will be recruited from the outpatient clinics for Gastrointestinal Diseases at Hospital Sønderjylland Hospital of Southern Jutland in the city of Aabenraa from from January to May 2024 Data collection will be completed in 2024
Clinical data consist of personal data patient-reported data on disease activity gastrointestinal symptoms fatigue level health related quality of life and dietary intake biomarkers in blood urine and faeces and protocol compliance measures Information registered by clinicians and technicians will be transferred from paper format to electronic format using either double entry of data or automated forms processing
Biologic material consist of blood faeces and urine samples All data are treated confidentially and stored according to the Danish Data Protection Regulation and Data Protection Law
Sample size considerations Sample size estimation was based on a 100 difference in the gastrointestinal symptoms score with a standard deviation SD of 180 which at a 5 significance level two-sided and with 80 statistical power would require a sample size of 28 completing participants Consequently it was decided to aim for a total sample size of 30 participants corresponding to a statistical power of 84
Project organization The project is part of a PhD doctor of philosophy study Collaborators are specialists from the gastrointestinal biochemical and microbiology departments involved in the project and professors in biostatistics and food sciences
The study is approved by the local Ethics Committee S-20210174 and the local Data Agency 2239335 The study findings will be disseminated in peer-reviewed journals via patient associations and presented at national and international conferences
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