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

June 27, 2018 updated by: 4D pharma plc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH6 1LF
        • Clinical Research Facility
      • Glasgow, United Kingdom, G514TF
        • Clinical Research Faciity
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust
    • Birmimgham
      • Birmingham, Birmimgham, United Kingdom, B46NH
        • Birmingham Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

  1. Subjects who are pregnant or breastfeeding.
  2. Subject who are experiencing an exacerbation at the time of screening or up to the time of the first dose.
  3. Subjects who have undergone previous surgery for resection of bowel.
  4. Subjects who have fistulisation.
  5. 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.
  6. Subjects who have taken systemic steroids in the last 3 months.
  7. Subjects who are unable to take any oral feeding.
  8. Subjects with feeding gastrostomies.
  9. Subjects who have non-food dietary supplementation for any reason changed within 1 month prior to dosing.
  10. Subjects who have received monoclonal antibodies in the 6 months prior to dosing.
  11. 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.
  12. Subjects who are receiving exclusive enteral feeding or have completed a course of exclusive enteral feeding in the 3 months prior to dosing.
  13. Subjects with concomitant autoimmune diseases.
  14. 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.
  15. 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.
  16. Subjects who are positive for the following viruses: HIV, hepatitis B and hepatitis C.
  17. Subjects who smoke cigarettes or use other tobacco or nicotine containing products, including e-cigarettes.
  18. Subjects who have a known sensitivity to any of the constituents of the investigational medicinal compound.
  19. Diastolic blood pressure <50 or >90 mmHg, a systolic blood pressure <100 or >150 mmHg, a pulse <40 or >100 beats per minute (bpm) after resting for 5 minutes.
  20. Subjects with clinically significantly abnormal ECGs or structural cardiac abnormalities e.g. valvular heart disease, patent foramen ovale.
  21. BMI Z SCORE less than -2.6 or greater than 2.6 (0 ± 2.6); i.e. below the 2nd centile or greater than the 98th centile.
  22. Any condition that, in the opinion of the Investigator, might interfere with the primary study objective.
  23. Subjects allergic to metronidazole and co-amoxiclav

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thetanix
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
Thetanix is an encapsulated lyophilised formulation of a pure culture of Bacteroides thetaiotaomicron with excipients.
Other Names:
  • B. theta
Placebo Comparator: Placebo
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
Placebo is encapsulated microcrystalline cellulose without Bacteroides thetaiotaomicron.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment emergent adverse events
Time Frame: Part A (single dose): Day 7. Part B (15 doses over 7.5 days): Day 14
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physician Global Assessment
Time Frame: Part B: Day 14
Change in Physician Global Assessment
Part B: Day 14
Weighted Paediatric Crohn's Disease Activity Index
Time Frame: Part B; Day 14
Change in Weighted Paediatric Disease Activity Index
Part B; Day 14
The number of subjects with abnormal clinically and non-clinically significant or out of expected range tests.
Time Frame: Part A: Day 7; Part B: Day 14
Tests include: Serum biochemistry and haematology; physical examinations, blood pressure, pulse rate, respiratory rate and oral temperature, weight, height, ECG parameters.
Part A: Day 7; Part B: Day 14
Part A: Faecal Microbiome Part B Microbiome and faecal calprotectin concentrations
Time Frame: Part B: Day 14
Stool samples will be collected and analysed for faecal calprotectin and microbial communities with specific interest in B. theta.
Part B: Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4D pharma plc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Theta 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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