Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD

Study Overview
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Brief Summary
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The objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. To this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (IBD) with and without associated primary sclerosing cholangitis (PSC-IBD).

Official Title
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Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD

Conditions
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Reduction of Intestinal Inflammatory Activity

Intervention / Treatment
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* Dietary Supplement: Gluten-free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of UC, CD or PSC-IBD Willingness, to follow a gluten-free diet for 78 weeks Stable therapeutic treatment for more 8 weeks For CD: Harvey Bradshaw index (HBI) of more 5 points, corresponding to a minimum of mild intestinal inflammation in CD For UC: Mayo Score of more 2 points, corresponding to a minimum of mild intestinal inflammation in UC Patient signed informed consent Exclusion Criteria: Antibiotics during last 4 weeks Intake of probiotics Gluten-free diet is already practiced Concomitant diagnosis of celiac disease Positive serology for transglutaminase IgA / IgG antibody or deamidated gliadin IgA / IgG Breast feeding Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gluten-free diet in Crohn disease<br> | Dietary Supplement: Gluten-free diet<br>* Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).<br>|
| Active Comparator: Gluten-free diet in ulcerative colitis<br> | Dietary Supplement: Gluten-free diet<br>* Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).<br>|
| Active Comparator: Gluten-free diet in Primary sclerosing cholangitis<br> | Dietary Supplement: Gluten-free diet<br>* Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in crohn´s disease (CD) | Change of Harvey bradshaw index (HBI) for CD following 78 weeks of long-term gluten free dietary intervention. HBI range from 0 to 18 points + number of daily liquid stools (remission: HBI < 5, active disease: HBI ≥ 5, severe disease: HBI ≥ 8) | 78 Weeks + 12 Month follow-up | 
| Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in ulcerative colitis (UC) and PSC-IBD | Change of partial Mayo Score (pMS) for UC and PSC-IBD following 78 weeks of long-term gluten free dietary intervention. pMS range from 0 to 12 points (remission: pMS < 2, mild activity: pMS 2-4, moderate activity: pMS 5-7, severe activity: pMS > 7). | 78 Weeks + 12 Month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients | Changes between baseline and end of dietary period in TNF-alpha of mucosal transcript profiles. | 78 Weeks + 12 Month follow-up | 
| The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients | Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles. | 78 Weeks + 12 Month follow-up | 
| The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients | Changes between baseline and end of dietary period in IL-6 mucosal transcript profiles. | 78 Weeks + 12 Month follow-up | 
| Long-term dietary influence on intestinal microbiome in IBD patient cohorts | Changes between baseline and end of dietary period in luminal microbiome dynamics from faecal samples identified by 16S RNA sequencing. | 78 Weeks + 12 Month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, PSC