Reduction of Intestinal Inflammatory Activity
Conditions
Keywords
IBD, PSC
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).
Interventions
DIETARY_SUPPLEMENTGluten-free diet
Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).
Sponsors
University Medical Centre Schleswig-Holstein
Lithuanian University of Health Sciences
University Medical Center Groningen, Netherland
Weizmann Institute of Science, Israel
Catholic University of the Sacred Heart
Eurice European Research and project office GMBH, Germany
Orebro University, Sweden
Region Capital Denmark
European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Changes between baseline and end of dietary period in TNF-alpha of mucosal transcript profiles. |
| 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 | Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles. |
| 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 | Changes between baseline and end of dietary period in IL-6 mucosal transcript profiles. |
| Long-term dietary influence on intestinal microbiome in IBD patient cohorts | 78 Weeks + 12 Month follow-up | Changes between baseline and end of dietary period in luminal microbiome dynamics from faecal samples identified by 16S RNA sequencing. |
Countries
Germany
Outcome results
None listed