A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's disease

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2014-005666-29-GB
• Date of registration: 11/09/2015
• Prospective Registration: Yes
• Primary sponsor: 4D Pharma
• Public title: A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's disease
• Scientific 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. - A study of Thetanix in young people with stable Crohn's disease
• Date of first enrolment: 16/10/2015
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005666-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Study management
• Affiliation: Ascot Research Consulting

• Name: Study management
• Affiliation: Ascot Research Consulting

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects aged 16 to 18 years 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.
Remission is defined as:
Physician's global assessment that subject is in remission; Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) less than or equal to 12.5; no clinically significant, in the opinion of the Investigator, elevations of platelets, white cell count, C-reactive protein or ESR and no clinically significant decrease in albumin or haemoglobin.
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1. Subjects who are pregnant or breastfeeding
2. Subjects who are experiencing an exacerbation at the time of screening or up to the time of the first dose.
3. Subjects who have undergone surgery for resection of bowel in the last 12 months or subjects who have undergone resection of bowel more than 12 months ago, and have experienced an exacerbation in the last 12 months or developed fistulae. (Subjects who have had resection of bowel more than 12 months ago, with no further requirement for surgery within the last 12 months, with stable medications as per other inclusion/exclusion criteria; and subjects who have surgery for perianal abscess more than 6 months prior to dosing remain eligible.)
4. Subjects who have fistulisation.
5. Subjects who have a significant change in their immune-modulating maintenance 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 (rectal and inhaled steroid use is permitted.)
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 are receiving a dose of monoclonal antibodies that has required adjustment, due to clinical indications relating to their underlying CD, and therefore has not been within a stable dosing range (e.g. 5mg/kg 8 weekly, allowing for changes in patient weight) for the past 12 months, or who have evidence of an exacerbation. (Note: subjects who have missed doses of monoclonal antibodies due to intercurrent illness unavailability, exams, holidays, other extraneous or non-clinical reasons are eligible).
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 (e.g. Type 1 diabetes, juvenile arthritis, psoriasis).
14. Female subjects of child bearing potential unwilling to use effective contraception. 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, IUDs (Intrauterine device), 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 (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial and withdrawal are not acceptable methods of contraception).
15. Subjects with clinically significant, in the opinion of the Investigator, elevated platelets, white cell count, C-reactive protein, ESR, low albumin or haemoglobin.
16. Subjects who are positive for the following viruses: HIV, hepatitis B and hepatitis C.
17. Subjects who

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Crohn's disease in young persons
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: Thetanix
Product Code: B. theta
Pharmaceutical Form: Capsule
INN or Proposed INN: Colony-purified Bacteroides thetaiotaomicron (B.theta)
Current Sponsor code: MRx1233 (previously LBP001)
Other descriptive name: B. theta
Concentration unit: CFU/g colony forming unit(s)/gram
Concentration type: range
Concentration number: 1E+7 to 1E+10-CFU/g
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective is to assess the tolerability and safety of B. theta when administered as a single dose and in multiple doses.

Timepoint(s) of evaluation of this end point: Adverse events will be assessed:
Part A: Day 0 (day of dosing) pre-dose, 2, 4 and 8 hours post dose; Day 1 (24 hours post-dose) and Day 7.
Part B: Day 0 pre, 2 and 4 hours post-first dose; Day 1, Day 7 pre, 2 and 4 hours post last dose, Day 14 and Day 56.
In addition, subjects will be required to complete an electronic diary to record adverse events and body temperature.

Secondary Objective: The exploratory objective is to assess the effect of administering single and multiple doses of B. theta on the gastrointestinal microbiome and the effect of multiple doses on faecal calprotectin as a non-invasive test to obtain a marker of intestinal inflammation.

Primary end point(s): The primary outcome measure is the incidence of adverse events assessed by treatment,severity and relationship to study medication.

Secondary Outcome(s)

Secondary end point(s): Secondary Safety measures: laboratory safety tests, physical examination, vital signs (blood pressure, pulse rate, respiratory rate, oral temperature), 12 lead ECG, BMI Z-score (Part B only), physician global assessment; weighted Paediatric Crohn's Disease Activity Index (wPCDAI). Blood cultures if clinically indicated due to fever.
Exploratory: Microbiome constituents and faecal calprotectin concentrations.

Timepoint(s) of evaluation of this end point: Lab safety tests: screen, Day 1; Day 7, Day 56
Physical examination: screen, Day 0, Day 7, Day 56
Vital signs: screen, Day 0, Day 1, Day 7, Day 14, Day 56
12 lead ECG: screen, Day 7
BMI Z score : screen, Day 0, Day 7, Day 14, Day 56
Physician global assessment: screen,Day 0, Day 7, Day 56
wPCDAI: screen, Day 0, Day 1, Day 7, Day 14, Day 56
Exploratory evaluations: Day 0;Day 1, Day 7, Day 56

Secondary ID(s)

NCT02704728

Theta001

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 01/11/2018
• Date Completed: 10/04/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005666-29/results