Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis

NCT07646223 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: R26052M2025-524543-12-00
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 1.Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)?
2. 2.How does oral vancomycin change gut metabolism?
3. 3.Does different types of colitis respond differently to oral vancomycin?
4. 4.Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response
5. 5.Visit the clinic approximately every 3 months for checkups, tests, and monitoring
6. 6.Provide blood, stool, and saliva samples to study disease activity and microbiota activity
7. 7.Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy
8. 8.Complete questionnaires about quality of life
9. 9.Be monitored for side effects and treatment response throughout the study period

Conditions

Ulcerative Colitis (UC); Primary Sclerosing Cholangitis (PSC); Pediatric Inflammatory Bowel Diseases

Keywords

PSC-UC; atypical UC; oral vancomycin; colitis; PIBD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in ALT levels

  6 to 12 months

• Change in the GGT levels

  6-12 months

• Change in the liver stiffness

  6-12 months

• Changes in the MRCP findings pre-post OVT

  12 months

Other Outcomes (1)

• Changes in gut microbiota and gut metabolism

  6 to 12 months

Study Arms (5)

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

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.

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

Interventions

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.

Children with atypical UC without confirmed PSC receiving OVt and conventional treatment; Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Fimlab laboratories: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Cholangitis, Sclerosing; Colitis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Laura Räisänen, PhD

CONTACT

+358444735309; laura.raisanen@pirha.fi

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)