NCT07240181
OPTImization of Inflammatory Bowel Disease Treatment Through Understanding of Gut VIRome Heterogeneity
Not Yet Recruiting · Not specified · Andreas Munk Petersen · registry updated 2025-11-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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
- 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.)