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

NCT02704728 | Completed

• 1 other identifier: Theta 001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief 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

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Part A (single dose): Day 7. Part B (15 doses over 7.5 days): Day 14

Secondary Outcomes (4)

• Physician Global Assessment

  Part B: Day 14

• Weighted Paediatric Crohn's Disease Activity Index

  Part B; Day 14

• The number of subjects with abnormal clinically and non-clinically significant or out of expected range tests.

  Part A: Day 7; Part B: Day 14

• Part A: Faecal Microbiome Part B Microbiome and faecal calprotectin concentrations

  Part B: Day 14

Study Arms (2)

Thetanix

EXPERIMENTAL

In Part A, 8 subjects will receive a single dose and in Part B, 8 subjects will receive twice daily doses for 7.5 days (a total of 15 doses). Each dose consists of three capsules

Other: Thetanix

Placebo

PLACEBO COMPARATOR

In Part A, 2 subjects will receive a single dose and in Part B, 2 subjects will receive twice daily doses for 7.5 days (a total of 15 doses). Each dose consists of three capsules.

Other: Placebo

Interventions

Thetanix OTHER

Thetanix is an encapsulated lyophilised formulation of a pure culture of Bacteroides thetaiotaomicron with excipients.

Also known as: B. theta

Thetanix

Placebo OTHER

Placebo is encapsulated microcrystalline cellulose without Bacteroides thetaiotaomicron.

Placebo

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects aged 16 to 18 years inclusive, with confirmed diagnosis of Crohn's disease who are currently in clinical remission\* in the opinion of the investigator and who are otherwise healthy.
• Subjects who are able and willing to give written informed consent to participate. If applicable, a parent/carer may also give consent to their participation.

You may not qualify if:

• Subjects who are pregnant or breastfeeding.
• Subject who are experiencing an exacerbation at the time of screening or up to the time of the first dose.
• Subjects who have undergone previous surgery for resection of bowel.
• Subjects who have fistulisation.
• Subjects who have had a significant change in their immune-modulating maintenance medication in the 3 months prior to screening and/or the start of dosing.
• Subjects who have taken systemic steroids in the last 3 months.
• Subjects who are unable to take any oral feeding.
• Subjects with feeding gastrostomies.
• Subjects who have non-food dietary supplementation for any reason changed within 1 month prior to dosing.
• Subjects who have received monoclonal antibodies in the 6 months prior to dosing.
• Subjects who have received antibiotics or probiotic dietary supplementation in the two weeks before dosing. Subjects who have received foods with probiotics e.g. yoghurts will be permitted to volunteer for the study.
• Subjects who are receiving exclusive enteral feeding or have completed a course of exclusive enteral feeding in the 3 months prior to dosing.
• Subjects with concomitant autoimmune diseases.
• Female Subjects of child bearing potential unwilling to use effective contraception from the signing of the consent form until completion of two periods after the last dose. An effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, Intrauterine Device (IUD), condoms, occlusive caps (cervical/vault caps) with spermicidal foam/gel/film/cream/pessary. True sexual abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject.
• Subjects with clinically significantly, in the opinion of the investigator, elevated platelets, white cell count, C-reactive protein, erythrocyte sedimentation rate (ESR), low albumin or haemoglobin.

Sponsors & Collaborators

• 4D pharma plc: lead

Study Sites (5)

Birmingham Children's Hospital

Birmingham, Birmimgham, B46NH, United Kingdom

Location

Clinical Research Facility

Edinburgh, EH6 1LF, United Kingdom

Location

Clinical Research Faciity

Glasgow, G514TF, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, L12 2AP, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (1)

• Hansen R, Sanderson IR, Muhammed R, Allen S, Tzivinikos C, Henderson P, Gervais L, Jeffery IB, Mullins DP, O'Herlihy EA, Weinberg JD, Kitson G, Russell RK, Wilson DC. A Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability of (Thetanix) Bacteroides thetaiotaomicron in Adolescent Crohn's Disease. Clin Transl Gastroenterol. 2020 Dec 18;12(1):e00287. doi: 10.14309/ctg.0000000000000287.

  PMID: 33464732 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Richard Hansen, MB ChB PhD FRCPCH

  South Glasgow University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• David Wilson, MD DCH FRCP(Edin) FRCPCH

  Royal Hospital for Sick Children Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: March 10, 2016
• Study Start: December 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)