Ulcerative Colitis (UC)Phase 2VERDANCT07646223
Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis
A Phase 2 study testing Oral Vancomycin in people with Ulcerative Colitis (UC) and Primary Sclerosing Cholangitis (PSC), run by Tampere University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC), Pediatric Inflammatory Bowel Diseases
- What is being tested?
- Oral Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2026to 31 Dec 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6-15 years
- able to swallow capsules
- are scheduled for diagnostic endoscopy at Tampere University
- has not received oral vancomycin before
- do not have active infection (such as clostridium or other bacteria)
- has not received new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT.
Who cannot join
- The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases.
- Under the age of 6 years old.
- Is unable to swallow capsules.
- Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin.
- Presence of malignant disease or potential need for liver transplantation within the following 12 months.
- Pregnancy
- Known renal insufficiency or chronic renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Tampere University Hospital
Tampere
Saara Ojala, saara.ojala@pirha.fi
About this study
Official title: The Efficacy of Oral Vancomycin Therapy in Managing Different Phenotypes of Paediatric Inflammatory Bowel Diseases by Correlating Treatment Response to Commensal Microbiota Composition and Function
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:
Read more
- Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)?
- How does oral vancomycin change gut metabolism?
- Does different types of colitis respond differently to oral vancomycin?
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:
- Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response
- Visit the clinic approximately every 3 months for checkups, tests, and monitoring
- Provide blood, stool, and saliva samples to study disease activity and microbiota activity
- Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy
- Complete questionnaires about quality of life
- Be monitored for side effects and treatment response throughout the study period
Read the detailed description
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:
- Does oral vancomycin improve disease activity and lead to remission based on clinical symptoms (PUCAI score), biomarkers (such as faecal calprotectin), imaging, and endoscopy findings?
- How does oral vancomycin change the gut microbiota and hut metabolism, and are these changes linked to treatment response?
- Does oral vancomycin improve liver-related outcomes in children with PSC-UC (e.g., liver enzymes and liver stiffness)?
- Does treatment improve the quality of life of children and their families?
- What medical problems, side effects, or risks do participants have when taking oral vancomycin, including the development of antibiotic-resistant bacteria?
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:
- Be children aged 6-15 years who are planned for colonoscopy due to suspected inflammatory bowel disease
- Be assigned to different groups based on their colonoscopy results (e.g., PSC-UC, atypical UC without PSC, typical UC, or healthy controls); children with atypical UC will be randomly assigned to receive oral vancomycin plus conventional treatment or conventional treatment alone
- Take oral vancomycin capsules (if assigned) in addition to standard therapy, typically three times per day, for at least 3 months and up to 12 months depending on treatment response
- Continue standard treatments for IBD (such as mesalazine, thiopurines, or biologics) as part of routine care
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:
- Symptom assessment using the Paediatric Ulcerative Colitis Activity Index (PUCAI)
- Blood tests to monitor inflammation, liver function, and general health
- Stool samples to measure faecal calprotectin and analyse gut microbiota
- Saliva samples to study microbiota composition
- Imaging tests such as intestinal ultrasound (to measure bowel wall thickness) and liver elastography (to assess liver stiffness)
- Magnetic resonance imaging (MRCP) in selected patients to assess bile duct disease
- Endoscopy and biopsies (at baseline and, if needed, during follow-up) to evaluate intestinal inflammation and healing
- Quality-of-life questionnaires completed by the child and/or their parents
Participants taking oral vancomycin will also be closely monitored for:
- side effects, including gastrointestinal symptoms such as nausea or diarrhoea
- Blood and stool testing will help identify potential complications, including development of vancomycin-resistant bacteria
- Treatment may be stopped early if the participant does not respond or if significant side effects occur
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.
- Conditions
- Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC), Pediatric Inflammatory Bowel Diseases
- Being tested
- Oral Vancomycin
- Keywords
- PSC-UC, atypical UC, oral vancomycin, colitis, PIBD
- Medical subject headings
- Colitis, Ulcerative, Cholangitis, Sclerosing, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral VancomycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Oral Vancomycin |
| 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. Receives: Drug: Oral Vancomycin |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 to 6 months
Secondary outcomes (4)
Change in ALT levels
Measured: 6 to 12 months
Change in the GGT levels
Measured: 6-12 months
Change in the liver stiffness
Measured using shear wave elastography
Measured: 6-12 months
Changes in the MRCP findings pre-post OVT
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fimlab laboratories, University of Helsinki
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646223
- Sponsor's protocol ID
- R26052M
- Other IDs
- 2025-524543-12-00, 2025
- Acronym
- VERDA
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical restriction
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Oral Vancomycin Therapy in Managing Different Phenotypes of Paediatric Inflammatory Bowel Diseases by Correlating Treatment Response to Commensal Microbiota Composition and Function
- ClinicalTrials.gov ID
- NCT07646223
- Acronym / sponsor ID
- VERDA / R26052M
- Conditions
- Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC), Pediatric Inflammatory Bowel Diseases
- Keywords
- PSC-UC, atypical UC, oral vancomycin, colitis, PIBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Fimlab laboratories, University of Helsinki
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)?
- How does oral vancomycin change gut metabolism?
- Does different types of colitis respond differently to oral vancomycin?
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:
- Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response
- Visit the clinic approximately every 3 months for checkups, tests, and monitoring
- Provide blood, stool, and saliva samples to study disease activity and microbiota activity
- Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy
- Complete questionnaires about quality of life
- Be monitored for side effects and treatment response throughout the study period
Detailed description
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:
- Does oral vancomycin improve disease activity and lead to remission based on clinical symptoms (PUCAI score), biomarkers (such as faecal calprotectin), imaging, and endoscopy findings?
- How does oral vancomycin change the gut microbiota and hut metabolism, and are these changes linked to treatment response?
- Does oral vancomycin improve liver-related outcomes in children with PSC-UC (e.g., liver enzymes and liver stiffness)?
- Does treatment improve the quality of life of children and their families?
- What medical problems, side effects, or risks do participants have when taking oral vancomycin, including the development of antibiotic-resistant bacteria?
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:
- Be children aged 6-15 years who are planned for colonoscopy due to suspected inflammatory bowel disease
- Be assigned to different groups based on their colonoscopy results (e.g., PSC-UC, atypical UC without PSC, typical UC, or healthy controls); children with atypical UC will be randomly assigned to receive oral vancomycin plus conventional treatment or conventional treatment alone
- Take oral vancomycin capsules (if assigned) in addition to standard therapy, typically three times per day, for at least 3 months and up to 12 months depending on treatment response
- Continue standard treatments for IBD (such as mesalazine, thiopurines, or biologics) as part of routine care
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:
- Symptom assessment using the Paediatric Ulcerative Colitis Activity Index (PUCAI)
- Blood tests to monitor inflammation, liver function, and general health
- Stool samples to measure faecal calprotectin and analyse gut microbiota
- Saliva samples to study microbiota composition
- Imaging tests such as intestinal ultrasound (to measure bowel wall thickness) and liver elastography (to assess liver stiffness)
- Magnetic resonance imaging (MRCP) in selected patients to assess bile duct disease
- Endoscopy and biopsies (at baseline and, if needed, during follow-up) to evaluate intestinal inflammation and healing
- Quality-of-life questionnaires completed by the child and/or their parents
Participants taking oral vancomycin will also be closely monitored for:
- side effects, including gastrointestinal symptoms such as nausea or diarrhoea
- Blood and stool testing will help identify potential complications, including development of vancomycin-resistant bacteria
- Treatment may be stopped early if the participant does not respond or if significant side effects occur
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment | Experimental | Drug: Oral VancomycinPSC is confirmed with MRCP and/or biopsy, will receive oral vancomycin (OVT) for 3-6-(12) months depending on the clinical response |
| Children with atypical UC without confirmed PSC receiving OVt and conventional treatment | Active comparator | Drug: Oral VancomycinPSC is not seen in MRCP, will receive oral vancomycin for 3-6-(12) months depending on the clinical response. |
| 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 |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children aged 6-15 years
- able to swallow capsules
- are scheduled for diagnostic endoscopy at Tampere University
- has not received oral vancomycin before
- do not have active infection (such as clostridium or other bacteria)
Key exclusion criteria (7 listed)
- The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases.
- Under the age of 6 years old.
- Is unable to swallow capsules.
- Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin.
- Presence of malignant disease or potential need for liver transplantation within the following 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral VancomycinOral 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. | Drug | Children with atypical UC without confirmed PSC receiving OVt and conventional treatment, Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment |
Primary outcome
Colitis remission
Time frame: 3 to 6 months
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
4 secondary outcomes
Change in ALT levels
Time frame: 6 to 12 months
Change in the GGT levels
Time frame: 6-12 months
Change in the liver stiffness
Time frame: 6-12 months
Changes in the MRCP findings pre-post OVT
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Ethical restriction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Vancomycin in people with Ulcerative Colitis (UC) and Primary Sclerosing Cholangitis (PSC), run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Räisänen, PhD (+358444735309, laura.raisanen@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colitis remission (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.