Carbapenem-Resistant Enterobacteriaceae InfectionPhase 2/3NCT04746222
Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization
A Phase 2/3 study testing Oral capsule faecal microbiota transplantation in people with Carbapenem-Resistant Enterobacteriaceae Infection, run by Tan Tock Seng Hospital.
Trial summary
Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enterobacteriaceae (CPE) intestinal decolonisation compared with placebo. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection
- What is being tested?
- Oral capsule faecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Jul 2023
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted as inpatient at the study site at the time of screening.
- Aged ≥21 years at the time of screening.
- Sufficiently ambulant to return for outpatient clinic study visit.
- Detection of CPE (result reported by clinical microbiology laboratory).
- Ability to provide informed consent.
- Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use at least one method of effective contraception for the duration of the trial.
Show all 10Show fewer
- Colonisation of the gastrointestinal tract with CPE, confirmed by at least one positive rectal swab taken ≤7 days before randomisation (direct PCR testing using Xpert Carba-R, performed by study team independent of the hospital screening protocol).
- Ability to swallow "safety test" capsule (one test capsule given during pre-randomisation evaluation).
- Antibiotics ceased for at least 48 hours before pre-randomisation evaluation.
- Negative urine pregnancy test for pre-menopausal women taken ≤7 days before randomisation
Who cannot join
- Presence of acute diarrhoeal illness (e.g. gastroenteritis, C. difficile colitis) or chronic diarrhoeal illness (e.g. irritable bowel syndrome or inflammatory bowel disease, unless they are in remission for at least 3 months prior to enrolment).
- Current use or planned use of an investigational drug within 3 months of enrolment.
- Presence of significant immunosuppression, including but not limited to: use of monoclonal antibody, use of prolonged steroids equivalent to prednisolone dose of ≥20mg/day for ≥28 days, solid organ transplantation, bone marrow transplantation, HIV infection with CD4 count of ≤200, bone marrow transplant, ongoing chemotherapy or radiation therapy, and congenital immunodeficiency.
- Oropharyngeal dysphagia, significant oesophageal dysphagia, or other inability to swallow.
- History of surgery altering gastrointestinal anatomy (e.g. colostomy, colectomy).
- Ileus or small bowel obstruction.
Show all 13Show fewer
- Risk of aspiration.
- History of gastroparesis.
- Severe food allergy (anaphylaxis or anaphylactoid reaction).
- Adverse event attributable to previous FMT.
- Those who are pregnant or plan to be pregnant within 3 months of enrolment.
- Those who are breastfeeding or plan to breastfeed during the trial.
- Life expectancy <3 months.
Trial locations and contacts
No sites are listed yet.
Kalisvar Marimuthu, MBBS contact
About this study
Official title: Oral Capsule-administered Faecal Microbiota Transplantation for Intestinal Carbapenemase-producing Enterobacteriaceae Decolonization
Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enterobacteriaceae (CPE) intestinal decolonisation compared with placebo. Primary outcome is the proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks after FMT treatment compared with placebo.
- Being tested
- Oral capsule faecal microbiota transplantation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral capsule faecal microbiota transplantationBiological
Single dose of 30 oral capsules containing healthy donor stool from a stool bank
PlaceboOther
Single dose of 30 oral placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Single dose of 30 oral capsules containing FMT from a stool bank Receives: Biological: Oral capsule faecal microbiota transplantation |
| Placebo | Placebo comparator | Single dose of 30 oral placebo capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks.
Decolonisation is determined by the following test outcomes:
- Negative PCR result (CP genes undetected) for rectal swab sample subjected to direct PCR (Xpert Carba-R) ii. Negative PCR result (CP genes undetected) for rectal swab sample subjected to culture on ChromID CARBA SMART media followed by PCR for suspected CPE colonies (Xpert Carba-R) iii. Negative PCR result (CP genes undetected) for stool sample subjected to direct PCR (Xpert Carba-R) iv. Negative PCR result (CP genes undetected) for stool sample subjected to culture on ChromID CARBA SMART media followed by PCR for suspected CPE colonies (Xpert Carba-R)
At least two of the four tests must be evaluable (clear positive or negative result obtained). Subject not meeting these criteria will be considered not-decolonised.
If any one of the PCR results are positive, the subject is considered not-decolonised.
Measured: 12 weeks
Secondary outcomes (4)
Proportion of patients successfully decolonised of CPE intestinal carriage at 1, 2, 6, 24, 36 and 48 weeks.
Decolonisation is determined by the following test outcomes:
- Negative PCR result (CP genes undetected) for stool sample subjected to direct PCR (Xpert Carba-R) ii. Negative PCR result (CP genes undetected) for stool sample subjected to culture on ChromID CARBA SMART media followed by PCR for suspected CPE colonies (Xpert Carba-R)
At least one of the two tests have to be evaluable (clear positive or negative result obtained). Subject not meeting these criteria will be considered not-decolonised.
If any one of the PCR results are positive, the subject is considered not-decolonised.
Measured: 1, 2, 6, 24, 36 and 48 weeks
Progression to CPE infection
Proportion of patients who progressed to CPE infection within 48 weeks, defined by isolation of CPE in a clinical isolate, compatible with an infective syndrome, as assessed by the study investigators.
Measured: Up to 48 weeks
Changes in stool microbiome
Projected output from metagenomics analysis (i and ii) and culture-based assays (iii):
- Comparison of gut microbial composition at 1, 2, 6, 12, 24, 36, and 48 weeks after treatment with FMT or placebo with composition at pre-randomisation (including Shannon Diversity Index) ii. Comparison of relative abundance of CP producing and non-CP producing species at 1, 2, 6, 12, 24, 36, and 48 weeks after treatment with FMT versus placebo iii. CPE load in stool at 1, 2, 6, 12, 24, 36, and 48 weeks post-treatment
Measured: 1, 2, 6, 12, 24, 36, and 48 weeks
Frequency and severity of adverse events
Comparison of the incidence and severity of all adverse events reported post-randomisation up to 48 weeks between the intervention and placebo groups.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomised controlled trial to evaluate the clinical efficacy of oral capsule administered FMT for CPE-intestinal decolonisation compared with placebo (1:1)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Oon Tek Ng, MBBS, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746222
- Sponsor's protocol ID
- CSAINV18nov-006
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Capsule-administered Faecal Microbiota Transplantation for Intestinal Carbapenemase-producing Enterobacteriaceae Decolonization
- ClinicalTrials.gov ID
- NCT04746222
- Acronym / sponsor ID
- CSAINV18nov-006
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enterobacteriaceae (CPE) intestinal decolonisation compared with placebo. Primary outcome is the proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks after FMT treatment compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomised controlled trial to evaluate the clinical efficacy of oral capsule administered FMT for CPE-intestinal decolonisation compared with placebo (1:1)
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Oral capsule faecal microbiota transplantationSingle dose of 30 oral capsules containing FMT from a stool bank |
| Placebo | Placebo comparator | Other: PlaceboSingle dose of 30 oral placebo capsules |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admitted as inpatient at the study site at the time of screening.
- Aged ≥21 years at the time of screening.
- Sufficiently ambulant to return for outpatient clinic study visit.
- Detection of CPE (result reported by clinical microbiology laboratory).
- Ability to provide informed consent.
Key exclusion criteria (13 listed)
- Presence of acute diarrhoeal illness (e.g. gastroenteritis, C. difficile colitis) or chronic diarrhoeal illness (e.g. irritable bowel syndrome or inflammatory bowel disease, unless they are in remission for at least 3 months prior to enrolment).
- Current use or planned use of an investigational drug within 3 months of enrolment.
- Presence of significant immunosuppression, including but not limited to: use of monoclonal antibody, use of prolonged steroids equivalent to prednisolone dose of ≥20mg/day for ≥28 days, solid organ transplantation, bone marrow transplantation, HIV infection with CD4 count of ≤200, bone marrow transplant, ongoing chemotherapy or radiation therapy, and congenital immunodeficiency.
- Oropharyngeal dysphagia, significant oesophageal dysphagia, or other inability to swallow.
- History of surgery altering gastrointestinal anatomy (e.g. colostomy, colectomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral capsule faecal microbiota transplantationSingle dose of 30 oral capsules containing healthy donor stool from a stool bank | Biological | Treatment |
| PlaceboSingle dose of 30 oral placebo capsules | Other | Placebo |
Primary outcome
Proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks.
Time frame: 12 weeks
Decolonisation is determined by the following test outcomes: i. Negative PCR result (CP genes undetected) for rectal swab sample subjected to direct PCR (Xpert Carba-R) ii. Negative PCR result (CP genes undetected) for rectal swab sample subjected to culture on ChromID CARBA SMART media followed by PCR for suspected CPE colonies (Xpert Carba-R) iii. Negative PCR result (CP genes undetected) for stool sample subjected to direct PCR (Xpert Carba-R) iv. Negative PCR result (CP genes undetected) for stool sample subjected to culture on ChromID CARBA SMART media followed by PCR for suspected CPE colonies (Xpert Carba-R) At least two of the four tests must be evaluable (clear positive or negative result obtained). Subject not meeting these criteria will be considered not-decolonised. If any one of the PCR results are positive, the subject is considered not-decolonised.
4 secondary outcomes
Proportion of patients successfully decolonised of CPE intestinal carriage at 1, 2, 6, 24, 36 and 48 weeks.
Time frame: 1, 2, 6, 24, 36 and 48 weeks
Progression to CPE infection
Time frame: Up to 48 weeks
Changes in stool microbiome
Time frame: 1, 2, 6, 12, 24, 36, and 48 weeks
Frequency and severity of adverse events
Time frame: Up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingObservational study
Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
Hemato-oncologic Patients, Colonization
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
Active, not recruiting
Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
Enterobacteriaceae Infections, Carrier State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalisvar Marimuthu, MBBS contact
Oon Tek Ng, MBBS principal investigator
Tan Tock Seng Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral capsule faecal microbiota transplantation in people with Carbapenem-Resistant Enterobacteriaceae Infection, run by Tan Tock Seng Hospital.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oon Tek Ng, MBBS (+65 6357 7318, Oon_Tek_NG@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.