AzTrials
AzTrials

Crohn's DiseaseNCT02704728

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

A study testing Thetanix in people with Crohn's Disease, run by 4D pharma plc at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 18 years
Conditions the study is for
Crohn's Disease
What is being tested?
Thetanix
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
5 sitesUnited Kingdom
Study dates
Dec 2015to Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • Subjects who are positive for the following viruses: HIV, hepatitis B and hepatitis C.
  • Subjects who smoke cigarettes or use other tobacco or nicotine containing products, including e-cigarettes.
  • Subjects who have a known sensitivity to any of the constituents of the investigational medicinal compound.
  • 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.
  • Subjects with clinically significantly abnormal ECGs or structural cardiac abnormalities e.g. valvular heart disease, patent foramen ovale.
  • 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.
  • Any condition that, in the opinion of the Investigator, might interfere with the primary study objective.
  • Subjects allergic to metronidazole and co-amoxiclav

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Birmingham Children's Hospital

    Birmingham, Birmimgham, B46NH

  • Clinical Research Facility

    Edinburgh, EH6 1LF

  • Clinical Research Faciity

    Glasgow, G514TF

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP

  • Barts Health NHS Trust

    London, E1 1BB

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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
Being tested
Thetanix, Placebo
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThetanixOther

    Also called B. theta

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

  • PlaceboOther

    Placebo is encapsulated microcrystalline cellulose without Bacteroides thetaiotaomicron.

Study groups in NCT02704728
Study groupRoleWhat they receive
ThetanixExperimentalIn 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
Receives: Other: Thetanix
PlaceboPlacebo comparatorIn 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Physician Global Assessment

    Change in Physician Global Assessment

    Measured: Part B: Day 14

  2. Weighted Paediatric Crohn's Disease Activity Index

    Change in Weighted Paediatric Disease Activity Index

    Measured: Part B; Day 14

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

    Tests include: Serum biochemistry and haematology; physical examinations, blood pressure, pulse rate, respiratory rate and oral temperature, weight, height, ECG parameters.

    Measured: Part A: Day 7; Part B: Day 14

  4. Part A: Faecal Microbiome Part B Microbiome and faecal calprotectin concentrations

    Stool samples will be collected and analysed for faecal calprotectin and microbial communities with specific interest in B. theta.

    Measured: Part B: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704728
Sponsor's protocol ID
Theta 001
Status last verified
Jun 2018
First submitted
12 Jan 2016
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33464732

Questions about this trial

What is this clinical trial studying?

A study testing Thetanix in people with Crohn's Disease, run by 4D pharma plc at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (time frame: Part A (single dose): Day 7. Part B (15 doses over 7.5 days): Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in