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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Children with atypical UC without confirmed PSC receiving OVt and conventional treatment
PSC is not seen in MRCP, will receive oral vancomycin for 3-6-(12) months depending on the clinical response.
干预措施: Oral Vancomycin (Drug)
Children with atypical UC without confirmed PSC receiving conventional treatment only
PSC is not seen in MRCP, will not receive oral vancomycin
Children without IBD
Control group for healthy gut microbiota and non-inflammatory gut metabolism
Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment
PSC is confirmed with MRCP and/or biopsy, will receive oral vancomycin (OVT) for 3-6-(12) months depending on the clinical response
干预措施: Oral Vancomycin (Drug)
Children with typical UC without confirmed PSC receiving conventional treatment only
Typical UC in colonoscopy, will not receive oral vancomycin