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

N/AActive Not RecruitingNCT05867537

Universitätsklinikum Hamburg-Eppendorf20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Reduction of Intestinal Inflammatory Activity

Interventions

Gluten-free dietDIETARY_SUPPLEMENT

Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: 78 Weeks + 12 Month follow-up

Secondary Outcomes

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.

Time frame: 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

Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.