Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Reduction of Intestinal Inflammatory Activity
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Investigators
Samuel Huber
Director of the I. Department of Medicine, Prof. Dr. med.
Universitätsklinikum Hamburg-Eppendorf
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Time Frame: 78 Weeks + 12 Month follow-up
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).
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)
Time Frame: 78 Weeks + 12 Month follow-up
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)
Secondary Outcomes
- The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients(78 Weeks + 12 Month follow-up)
- Long-term dietary influence on intestinal microbiome in IBD patient cohorts(78 Weeks + 12 Month follow-up)
- The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients(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(78 Weeks + 12 Month follow-up)