The purpose of this study is to assess the safety and tolerability of Bacteroides thetaiotaomicron (Thetanix®)) capsules in young people aged 16 to 18 years with stable Crohn's disease.
This study is a single (Part A) and multiple (Part B) dose study. Following informed consent and screening, 10 eligible subjects will receive a single dose of Thetanix or placebo in the clinic. A Safety Review Committee will review the safety data up to Day 7 from these first ten subjects and determine if it is appropriate to continue into Part B in which 10 subjects will receive 15 doses of Thetanix or placebo in a twice daily dosing regimen over 7.5 days. In both parts of the study, 8 of the 10 subjects will randomly receive Thetanix and 2 subjects will randomly receive placebo. Each dose consists of three capsules. Subjects in Part B will receive the first and last dose in the clinic and will take 13 doses at home. While at home, subjects will be required to answer questions about their health, record their body temperature and when they take the capsules in an electronic diary. Subjects developing a fever will undergo further assessments, including blood cultures. Subjects will provide stool samples for analysis of microbiota and faecal calprotectin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Birmingham Children's Hospital
Birmingham, Birmimgham, United Kingdom
Clinical Research Facility
Edinburgh, United Kingdom
Clinical Research Faciity
Glasgow, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Incidence of treatment emergent adverse events
The change from baseline will be assessed at Day 7 (Part A) and at Day 14 (Part B). Part A and Part B will be analysed separately as they are of different duration. The primary endpoint for each part is taken as 7 days after the last dose.
Time frame: Part A (single dose): Day 7. Part B (15 doses over 7.5 days): Day 14
Physician Global Assessment
Change in Physician Global Assessment
Time frame: Part B: Day 14
Weighted Paediatric Crohn's Disease Activity Index
Change in Weighted Paediatric Disease Activity Index
Time frame: Part B; Day 14
The number of subjects with abnormal clinically and non-clinically significant or out of expected range tests.
Tests include: Serum biochemistry and haematology; physical examinations, blood pressure, pulse rate, respiratory rate and oral temperature, weight, height, ECG parameters.
Time frame: Part A: Day 7; Part B: Day 14
Part A: Faecal Microbiome Part B Microbiome and faecal calprotectin concentrations
Stool samples will be collected and analysed for faecal calprotectin and microbial communities with specific interest in B. theta.
Time frame: Part B: Day 14
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Barts Health NHS Trust
London, United Kingdom