VANCOMYCIN HYDROCHLORIDE for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- 6-16 years old with established diagnosis of atypical UC (presenting right-sided colitis, backwash ileitis, or rectal sparing, and/or positive atypical pANCA or PR3-ANCA) with confirmed PSC in MRCP (PSC-UC) or without detectable PSC (aUC-non-PSC), and children with typical UC without PSC\n- Has nor received OVT preciously, but patients and/or their guardians has given an informed consent to commence OVT for at least 3 months for treating PSC-UC or aUC-non-PSC\n- Able to swallow capsules\n- Do not have active infection (such as clostridium or other bacteria) if the clinical stool screening before starting OVT\n- No new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT • May use contraceptives or other medications that are not antibiotics\n- May use contraceptives or other medications that are not antibiotics\n- For healthy participant: no symptoms or suspicion of inflammatory bowel diseases but are scheduled for endoscopy for other reasons"}

Exclusion criteria

• {"criterion_text":"- PSC without UC; Crohn’s disease type of inflammatory bowel diseases.\n- Under the age of 6 years old\n- Is unable to swallow capsules\n- Had a previous allergic reactions to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin\n- Presence of malignant disease or potential need for liver transplantation within the following 12 months\n- Pregnancy\n- For healthy controls: presence of chronic illness requiring long-term medications, use of antibiotics within the past 6 months"}

Primary endpoints

• {"endpoint_text":"- Suolen tervehtyminen (remissio eli lapsi on oireeton ja ulosteen kalprotektiini on alle 100)","definition_or_measurement_approach":"Remission defined as the child being asymptomatic and faecal calprotectin below 100 (as stated in parentheses)."}
• {"endpoint_text":"- Miltä suolen bakteeristo näyttää ennen vankomysiinihoitoa tai tavanomaista hoitoa tulehduksen aikana ja remissiossa hoidon aloittamisen jälkeen","definition_or_measurement_approach":"Assessment of gut microbiota composition and function before vancomycin therapy or conventional treatment during inflammation and in remission after treatment initiation (microbiota composition/function analysis as stated)."}

Finland

Earliest CTIS Part Ii Submission Date

25-02-2026

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

34

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Pirkanmaan hyvinvointialue

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland