A study of Thetanix in young people with stable Crohn's disease
Research type
Research Study
Full title
A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease.
IRAS ID
186590
Contact name
Douglas Thomson
Contact email
Sponsor organisation
4D Pharma
Eudract number
2014-005666-29
Clinicaltrials.gov Identifier
NCT 02704728
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a study to assess the safety and tolerability of Thetanix in young people with stable Crohn's disease. The study will start with a single dose of Thetanix administered to ten subjects between 16 and 18 years of age who have stable Crohns' disease i.e. are in remission. Once safety in this group is established by a review of the safety data by a Safety Review Committee, the study will be expanded to administer multiple doses (15 doses)to subjects who are between 16 and 18 years of age. We are not looking for any benefit from the intervention in this study- this will be addressed in a future study if the intervention is well tolerated here. We are however planning to explore both the logistics of collecting further samples for analysis and preliminary signals of microbial effect during this study, hence we will be collecting samples for analysis at different points during the study.
REC name
West of Scotland REC 1
REC reference
15/WS/0166
Date of REC Opinion
22 Sep 2015
REC opinion
Further Information Favourable Opinion