OPTImization of Inflammatory Bowel Disease Treatment Through Understanding of Gut VIRome Heterogeneity (OPTIVIR)

Optimization of Inflammatory Bowel Disease Treatment Through Understanding of Gut Virome Heterogeneity and the Potential for Bacteriophage-based Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohns Disease; Colitis Ulcerative; IBD (Inflammatory Bowel Disease)

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Andreas M Petersen, Professor; Phone Number: +4538626199; Email: andreas.munk.petersen@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
    • Contact: Andreas M. Petersen, Professor; Phone Number: +4538626199; Email: Andreas.Munk.Petersen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion criteria for patients:

• 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 for patients:

• 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.)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Andreas Munk Petersen
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Sofie I Halkjær, PhD, Hvidovre University Hospital; Principal Investigator: Torben S Rasmussen, PhD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Bacteriophage therapy; Bacteriophages; Gut virome; Fecal virome transplantation; Fecal filtrate transplantation; Gut microbiome imbalances
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: H-25044017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No