NCT02704728

Study of Bacteroides Thetaiotaomicron in Young People Aged 16 to 18 Years With Stable Crohn's Disease

A 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: 4D pharma plc · Industry
• Sex: All
• Age: 16 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Thetanix	Thetanix is an encapsulated lyophilised formulation of a pure culture of Bacteroides thetaiotaomicron with excipients.
OTHER	Placebo	Placebo is encapsulated microcrystalline cellulose without Bacteroides thetaiotaomicron.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-03-10
• Last updated: 2018-06-28

Locations

5 sites across 1 country: United Kingdom