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

NCT02704728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-06-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • 4D pharma plc

    lead INDUSTRY

Principal Investigators

  • Richard Hansen, MB ChB PhD FRCPCH · South Glasgow University Hospitals NHS Trust

  • David Wilson, MD DCH FRCP(Edin) FRCPCH · Royal Hospital for Sick Children Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02704728 on ClinicalTrials.gov