OPTImization of Inflammatory Bowel Disease Treatment Through Understanding of Gut VIRome Heterogeneity
Observational · No treatment assigned · 1 site · Andreas Munk Petersen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD (Inflammatory Bowel Disease), Crohns Disease and Colitis Ulcerative. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-12-01 (planned).
- Main results expected around 2029-12-31 (estimate from the record).
- 1 study site listed in Denmark.
Main thing being measured
- To characterize gut bacteriophages and bacteria in patients with IBD and in healthy controls (fecal donors), both as before and after fermentation in bioreactors (3 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD (Inflammatory Bowel Disease); Crohns Disease; Colitis Ulcerative |
| Lead sponsor | Andreas Munk Petersen |
| Collaborators | University of Copenhagen |
| Enrollment | 40 (estimated) |
| Start date | 2025-12-01 |
| Primary completion (est.) | 2029-12-31 |
| First posted | 2025-11-20 |
| Last updated | 2025-11-20 |
| Official title | Optimization of Inflammatory Bowel Disease Treatment Through Understanding of Gut Virome Heterogeneity and the Potential for Bacteriophage-based Therapy |
| ClinicalTrials.gov ID | NCT07240181 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hvidovre Hospital | Hvidovre | Denmark |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.