OPTImization of Inflammatory Bowel Disease Treatment Through Understanding of Gut VIRome Heterogeneity

NCT ID: NCT07240181

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-12-31

Brief Summary

Title: The Role of Good Viruses in Inflammatory Bowel Disease

Background An imbalance in the bacteria in the gut - called gut dysbiosis - is linked to chronic bowel diseases such as Crohn's disease and ulcerative colitis (IBD). A special and more severe form of IBD, called primary sclerosing cholangitis-associated IBD (PSC-IBD), affects both the gut and the bile ducts, and in serious cases can lead to liver failure. There is currently no cure for IBD.

Research suggests that microorganisms in the gut, especially bacteria and viruses called bacteriophages, play an important role in how the disease develops. Treatment with stool from healthy donors, known as fecal microbiota transplantation (FMT), has proven effective against certain infections and has shown promising results in IBD. A newer and possibly safer method is fecal virome transplantation (FVT), where only the virus part (the gut virome) of the stool is used.

Bacteriophages can kill harmful bacteria and help restore balance in the gut, but their use is still experimental. Therefore, we aim to develop a new treatment by growing bacteriophages from healthy individuals in the lab and using them to restore a healthy balance of bacteria and viruses in the gut of patients with IBD.

Purpose of the study The long-term goal of the study is to improve treatment for IBD by gaining a better understanding of differences in the gut virome between IBD patients and healthy people. We also want to explore whether "fermented" bacteriophages from donor stool can be developed into a future bacteriophage-based therapy.

This will be studied using experimental lab setups and animal models. The study will include 10 healthy stool donors and 30 IBD patients (10 with ulcerative colitis, 10 with Crohn's disease, and 10 with PSC-IBD). The study does not involve any treatments - only the collection of biological samples and access to information about your health from your medical record.

Conditions

IBD (Inflammatory Bowel Disease); Crohns Disease; Colitis Ulcerative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ulcerative colitis (UC)

• Confirmed diagnosis of UC for at least 6 months
• Age ≥ 18 years
• Stable medical treatment for IBD during the past 3 months
• Stable lifestyle within the past month (including diet, physical activity, and sleep habits)
• Verbal and written informed consent

No interventions assigned to this group

Crohns disease (CD)

• Confirmed diagnosis of CD for at least 6 months
• Age ≥ 18 years
• Stable medical treatment for IBD during the past 3 months
• Stable lifestyle within the past month (including diet, physical activity, and sleep habits)
• Verbal and written informed consent

No interventions assigned to this group

Primary Sclerosing Cholangitis and Inflammatory Bowel Disease (PSC-IBD)

• Confirmed diagnosis of PSC-IBD for at least 6 months
• Age ≥ 18 years
• Stable medical treatment for PSC-IBD during the past 3 months
• Stable lifestyle within the past month (including diet, physical activity, and sleep habits)
• Verbal and written informed consent

No interventions assigned to this group

Healthy controls (fecal donors)

Donors who are already part of the existing donor program at the Department of Infectious Diseases, Hvidovre Hospital, will serve as healthy controls. Verbal and written informed consent

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of UC, CD, or PSC-IBD for at least 6 months
• Age ≥ 18 years
• Stable medical treatment for IBD (and PSC-IBD) within the past 3 months
• Stable lifestyle within the past month (including diet, exercise, and sleep habits)
• Verbal and written informed consent

Exclusion Criteria

• Use of antibiotics within the past 3 months
• Pregnancy or breastfeeding
• Substance abuse or excessive alcohol consumption (according to Danish Health Authority guidelines)
• Other known comorbidities that may affect the gut microbiome (e.g., type 1 diabetes, other autoimmune diseases, cancer, severe obesity, etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Andreas Munk Petersen

OTHER

Sponsor Role: lead

Responsible Party

Andreas Munk Petersen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sofie I Halkjær, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Torben S Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Hvidovre Hospital

Hvidovre, , Denmark

Countries

Denmark

Central Contacts

Andreas M Petersen, Professor

Role: CONTACT

andreas.munk.petersen@regionh.dk

+4538626199

Facility Contacts

Andreas M. Petersen, Professor

Role: primary

Andreas.Munk.Petersen@regionh.dk

+4538626199

Other Identifiers

H-25044017

Identifier Type: -

Identifier Source: org_study_id