Efficacy of Oral Vancomycin in Paediatric Inflammatory Bowel Disease: Correlating Clinical Response with Commensal Microbiota Composition and Function

The primary objective of this study is to evaluate the efficacy of oral vancomycin therapy in the management of various phenotypes of paediatric inflammatory bowel disease, specifically focusing on ulcerative colitis. The investigation involves comparing pre-treatment and post-treatment clinical findings in correlation with alterations in the composition and function of commensal microbiota. This evaluation aims to determine how microbial profiles influence therapeutic response. 5, 3, 4.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients and healthy individuals. The pediatric cohort includes children aged 6 to 16 years diagnosed with ulcerative colitis. Specifically, the study includes patients with atypical ulcerative colitis, characterized by right-sided colitis, backwash ileitis, rectal sparing, or positive pANCA or PR3-ANCA, both with and without primary sclerosing cholangitis confirmed via MRCP. Typical cases of ulcerative colitis without primary sclerosing cholangitis are also included. Participants must be able to swallow capsules and must not have an active infection, such as Clostridium, at the time of stool screening. Inclusion requires that no new medications or conventional therapies for inflammatory bowel disease have been administered within four weeks prior to oral vitamin therapy. Healthy participants are defined as individuals without symptoms or suspicion of inflammatory bowel disease who are scheduled for endoscopy for other reasons. The population includes both males and females.

This Phase II clinical trial evaluates the efficacy of oral vancomycin therapy in managing various phenotypes of ulcerative colitis in paediatric patients. The research methodology focuses on comparing pre-treatment and post-treatment clinical findings in correlation with changes in commensal microbiota composition and function. Participants must be between 6 and 16 years of age with an established diagnosis of atypical or typical ulcerative colitis. The primary endpoints include the achievement of clinical remission, defined by the absence of symptoms and a fecal calprotectin level below 100, as well as assessments of the intestinal microbiota. The study involves an initial screening to confirm diagnosis, ensure the absence of active infections such as Clostridium, and verify that no new inflammatory bowel disease interventions were administered within 4 weeks. Following screening, patients undergo oral vancomycin therapy for a minimum duration of 3 months. The trial is expected to conclude recruitment by 2030. Participant involvement may be subject to early termination based on clinical requirements or protocol adherence.

The experimental treatment consists of vancomycin hydrochloride administered as a hard capsule. The total daily dosage is 1500 mg, which is delivered via the oral route.

The efficacy of oral vancomycin therapy in managing ulcerative colitis is evaluated by comparing pre- and post-treatment clinical findings. The primary endpoint is defined as clinical remission, characterized by the absence of symptoms and a fecal calprotectin level of less than 100. Additionally, the assessment includes analyzing the composition and function of the commensal microbiota before the initiation of vancomycin or standard treatment during inflammation and following the achievement of remission.