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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07240181
Acronym
OPTIVIR
Enrollment
40
Registered
2025-11-20
Start date
2025-12-01
Completion date
2029-12-31
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

University of Copenhagen
CollaboratorOTHER
Andreas Munk Petersen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
To characterize gut bacteriophages and bacteria in patients with IBD and in healthy controls (fecal donors), both as before and after fermentation in bioreactors3 years16S rRNA gene and metagenome sequencing

Countries

Denmark

Contacts

Primary ContactAndreas M Petersen, Professor
andreas.munk.petersen@regionh.dk+4538626199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026