Clinical trial NCT05867537: Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
Official title: Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Reduction of Intestinal Inflammatory Activity
Keywords: IBD
PSC
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University Medical Centre Schleswig-Holstein
name: Lithuanian University of Health Sciences
name: University Medical Center Groningen, Netherland
name: Weizmann Institute of Science, Israel
name: Catholic University of the Sacred Heart
name: Eurice European Research and project office GMBH, Germany
name: Orebro University, Sweden
name: Region Hovedstaden, Denmark
name: European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
First posted: 2023-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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)
timeFrame: 78 Weeks + 12 Month follow-up
measure: 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
timeFrame: 78 Weeks + 12 Month follow-up
Secondary outcomes:
measure: The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients
timeFrame: 78 Weeks + 12 Month follow-up
measure: The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients
timeFrame: 78 Weeks + 12 Month follow-up
measure: The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients
timeFrame: 78 Weeks + 12 Month follow-up
measure: Long-term dietary influence on intestinal microbiome in IBD patient cohorts
timeFrame: 78 Weeks + 12 Month follow-up
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
Study officials:
References: