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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524543-12-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Fimlab laboratories | UNKNOWN |
| University of Helsinki | OTHER |
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The goal of this clinical trial is to learn how oral vancomycin therapy may contribute in treating paediatric inflammatory bowel disease, particularly atypical ulcerative colitis and PSC-associated colitis. It will also give more information on how this treatment affects gut microbiota and metabolism.
The main questions it aims to answer are:
Researchers will compare children receiving oral vancomycin plus standard therapy to those receiving standard therapy alone. The gut metabolisim before and after oral vancmycin will also be compared, as well as to healthy controls and children with typical ulcerative colitis.
Participants will:
The goal of this clinical trial is to learn whether oral vancomycin therapy could be used to treat paediatric inflammatory bowel diseases (IBD), particularly atypical ulcerative colitis and ulcerative colitis associated with primary sclerosing cholangitis (PSC-UC). This trial will also investigate how oral vancomycin may affect gut microbiota (the community of bacteria in the gut) and change gut metabolism, influence disease progression, and exhibit overall safety during long-term use.
The main questions it aims to answer are:
Researchers will compare groups of children receiving oral vancomycin together with conventional medical treatment (CMT) to those receiving conventional treatment alone in certain patient groups. They will also compare stool and gut metabolims findings with children who have typical ulcerative colitis, and with healthy controls.
The participants will:
Participants will attend clinic visits and follow-ups at baseline (before treatment) and then approximately every 3 months (at 3, 6, 9, and 12 months) while receiving oral vancomycin. After ceasing oral vancomycin, they will be followed-up for another 12 months - up to 2 years after the start of the study
During the study, participants will undergo a range of clinical assessments and tests, including:
Participants taking oral vancomycin will also be closely monitored for:
Researchers will analyse changes over time in clinical outcomes, microbiota composition, gut metabolism, and laboratory findings to determine whether oral vancomycin is effective and safe. They will also investigate whether changes in the microbiome can predict which patients respond to treatment.
Overall, this study aims to improve understanding of paediatric IBD, especially atypical forms linked to PSC, and to evaluate whether modifying gut bacteria with oral vancomycin can lead to better disease control, improved quality of life, and more personalised treatment strategies for children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment | Experimental | PSC is confirmed with MRCP and/or biopsy, will receive oral vancomycin (OVT) for 3-6-(12) months depending on the clinical response |
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| Children with atypical UC without confirmed PSC receiving OVt and conventional treatment | Active Comparator | PSC is not seen in MRCP, will receive oral vancomycin for 3-6-(12) months depending on the clinical response. |
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| Children with atypical UC without confirmed PSC receiving conventional treatment only | No Intervention | PSC is not seen in MRCP, will not receive oral vancomycin | |
| Children with typical UC without confirmed PSC receiving conventional treatment only | No Intervention | Typical UC in colonoscopy, will not receive oral vancomycin | |
| Children without IBD | No Intervention | Control group for healthy gut microbiota and non-inflammatory gut metabolism |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Vancomycin | Drug | Oral vancomycin will be given 50 mg/ kg in three divided doses up to 500 mg x 3/ day for at least 3 months. In responding children, the treatment will be continued for 6(-12) months depending on the timing if possible follow-up colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Colitis remission | Remission is defined as PUCAI < 10, fecal calprotectin < 100 ug/g, and normal bowel wall thickness in all segments of the colon at intestinal ultrasound | 3 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ALT levels | 6 to 12 months | |
| Change in the GGT levels | 6-12 months | |
| Change in the liver stiffness |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut microbiota and gut metabolism | Stool samples will be analyzed for gut microbiota diversity and biopsy samples for gut metabolism (using Olink proteomics) | 6 to 12 months |
Inclusion criteria.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Räisänen, PhD | Contact | +358444735309 | laura.raisanen@pirha.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | Finland |
Ethical restriction
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015209 | Cholangitis, Sclerosing |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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Measured using shear wave elastography |
| 6-12 months |
| Changes in the MRCP findings pre-post OVT | 12 months |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |