Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
| Lithuanian University of Health Sciences | OTHER |
| University Medical Center Groningen, Netherland | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluten-free diet in Crohn disease | Active Comparator |
| |
| Gluten-free diet in ulcerative colitis | Active Comparator |
| |
| Gluten-free diet in Primary sclerosing cholangitis | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten-free diet | Dietary Supplement | Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD). |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
Not provided
Not provided
| Weizmann Institute of Science, Israel |
| UNKNOWN |
| Catholic University of the Sacred Heart | OTHER |
| Eurice European Research and project office GMBH, Germany | UNKNOWN |
| Orebro University, Sweden | UNKNOWN |
| Region Capital Denmark | OTHER |
| European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |