Back to resultsProof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
Primary Purpose
Reduction of Intestinal Inflammatory Activity
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
About this trial
This is an interventional treatment trial for Reduction of Intestinal Inflammatory Activity focused on measuring IBD, PSC
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
Sites / Locations
- Universitätsklinikum Hamburg EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Gluten-free diet in Crohn disease
Gluten-free diet in ulcerative colitis
Gluten-free diet in Primary sclerosing cholangitis
Arm Description
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05867537
First Posted
April 3, 2023
Last Updated
May 10, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
University Medical Centre Schleswig-Holstein, Lithuanian University of Health Sciences, University Medical Center Groningen, Netherland, Weizmann Institute of Science, Israel, Sacred Heart Catholic University, Italy, Eurice European Research and project office GMBH, Germany, Orebro University, Sweden, Region Hovedstaden, Denmark, European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT05867537
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
University Medical Centre Schleswig-Holstein, Lithuanian University of Health Sciences, University Medical Center Groningen, Netherland, Weizmann Institute of Science, Israel, Sacred Heart Catholic University, Italy, Eurice European Research and project office GMBH, Germany, Orebro University, Sweden, Region Hovedstaden, Denmark, European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Intestinal Inflammatory Activity
Keywords
IBD, PSC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gluten-free diet in Crohn disease
Arm Type
Active Comparator
Arm Title
Gluten-free diet in ulcerative colitis
Arm Type
Active Comparator
Arm Title
Gluten-free diet in Primary sclerosing cholangitis
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten-free diet
Intervention Description
Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
78 Weeks + 12 Month follow-up
Title
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
Description
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).
Time Frame
78 Weeks + 12 Month follow-up
Secondary Outcome Measure Information:
Title
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients
Description
Changes between baseline and end of dietary period in TNF-alpha of mucosal transcript profiles.
Time Frame
78 Weeks + 12 Month follow-up
Title
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients
Description
Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles.
Time Frame
78 Weeks + 12 Month follow-up
Title
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients
Description
Changes between baseline and end of dietary period in IL-6 mucosal transcript profiles.
Time Frame
78 Weeks + 12 Month follow-up
Title
Long-term dietary influence on intestinal microbiome in IBD patient cohorts
Description
Changes between baseline and end of dietary period in luminal microbiome dynamics from faecal samples identified by 16S RNA sequencing.
Time Frame
78 Weeks + 12 Month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehra Oguz-Cöloglu
Phone
040741053863
Email
z.oguz-coeloglu@uke.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
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