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

Reduction of Intestinal Inflammatory Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867537
• Other study ID #: miGut Health
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: January 2028

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Reduction of Intestinal Inflammatory Activity

Intervention

Dietary Supplement:
• Gluten-free diet
Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg

Sponsors (10)

Lead Sponsor

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Eurice European Research and project office GMBH, Germany, European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium, Lithuanian University of Health Sciences, Orebro University, Sweden, Region Hovedstaden, Denmark, Sacred Heart Catholic University, Italy, University Medical Center Groningen, Netherland, University Medical Centre Schleswig-Holstein, Weizmann Institute of Science, Israel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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.	78 Weeks + 12 Month follow-up
Secondary	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
Secondary	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