Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD

Not Applicable

Recruiting

• Conditions: Reduction of Intestinal Inflammatory Activity
• Interventions: Dietary Supplement: Gluten-free diet

• Registration Number: NCT05867537
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-18
• Study First Submitted: 2023-04-03
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten-free diet in ulcerative colitis	Gluten-free diet	-
Gluten-free diet in Primary sclerosing cholangitis	Gluten-free diet	-
Gluten-free diet in Crohn disease	Gluten-free diet	-

Primary Outcome Measures

Name	Time	Method
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).
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)

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Universitätsklinikum Hamburg Eppendorf; 🇩🇪 Hamburg, Germany