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

NCT07240181 | Not Yet Recruiting

• 1 other identifier: H-25044017
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Bacteriophages; Gut virome; Bacteriophage therapy; Fecal virome transplantation; Fecal filtrate transplantation; Gut microbiome imbalances

Outcome Measures

Primary Outcomes (1)

• To characterize gut bacteriophages and bacteria in patients with IBD and in healthy controls (fecal donors), both as before and after fermentation in bioreactors

  16S rRNA gene and metagenome sequencing

  3 years

Study Arms (4)

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is a non-interventional trial aiming to examine the virome/bacteriophages from stool samples of patients with IBD (UC, CD, and PSC-IBD) and compare these with healthy controls (fecal donors). Study participants The study will include 30 patients with IBD: 10 with ulcerative colitis (UC), 10 with Crohn's disease (CD), and 10 with PSC-IBD. In each subgroup, 5 participants with active disease and 5 in remission will be included (active disease is defined as fecal calprotectin \> 250). In addition, 10 fecal donors will be included as healthy controls.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Andreas Munk Petersen: lead
• University of Copenhagen: collaborator

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Sofie I Halkjær, PhD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Torben S Rasmussen, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas M Petersen, Professor

CONTACT

+4538626199; andreas.munk.petersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)