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Clostridium Difficile InfectionPhase 2NCT01398969

Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI

A Phase 2 study testing Fresh FMT and Frozen-and-Thawed FMT in people with Clostridium Difficile Infection, run by McMaster University at 4 sites in Canada.

Completed

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

Official record
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Trial summary

The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clostridium Difficile Infection
What is being tested?
Fresh FMT and Frozen-and-Thawed FMT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
4 sitesCanada
Study dates
Jul 2012to Mar 2015
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Patient inclusion criteria

  1. Age 18 years or older.
  2. Able to provide informed consent.
  3. Laboratory or pathology: confirmed diagnosis of recurrent CDI with symptoms (defined below) within the previous 180 days.
  4. ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for at least 5 days.

Symptoms of CDI, diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea. Subjects will be required to have laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection where recurrence is defined as return of diarrhea and positive stool test after a period of symptom resolution within 8 weeks of the first episode and has received at least a 10-day course of standard antibiotic therapy.

Patient exclusion criteria

  1. Planned or actively participating in another clinical trial.
  2. Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
  3. Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
  4. Peripheral white blood cell count > 30.0 x 10E9/L AND temperature > 38.0 oC
  5. Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
  6. Presence of colostomy
  7. Unable to tolerate HBT or enema for any reason.
  8. Requiring systemic antibiotic therapy for more than 7 days.
  9. Actively taking Saccharomyces boulardii
  10. Severe underlying disease such that the patient is not expected to survive for at least 30 days.
  11. Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Donor inclusion

  1. Able to provide and sign informed consent.
  2. Able to complete and sign the donor questionnaire
  3. Able to adhere to fecal transplantation stool collection standard operating procedure.

Donor exclusion

  1. Tested positive for any of the following: Human Immunodeficiency virus (HIV) 1/2, hepatitis IgM, hepatitis B (HBsAg), hepatitis C antibody, syphilis, human T- lymphotrophic virus (HTLV) 1/II and vancomycin resistant Enterococcus (VRE), methicillin resistant S. aureus (MRSA), Salmonella, Shigella, E.coli O157 H7, Yersinia and Campylobacter.
  2. Detection of ova, parasites, C. difficile toxin, norovirus, adenovirus, rotavirus on stool examination
  3. History of any type of active cancer or autoimmune disease
  4. History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire, appendix B.
  5. History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
  6. Receipt of blood transfusion from a country other than Canada in preceding 6 months
  7. Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
  8. Receipt of any type of live vaccine within 3 months prior to stool donation
  9. Ingestion of nut or shell fish 3 days preceding donation if the recipient has known allergies to these food.
  10. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the donor

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • St. Joseph's Hospital

    Hamilton, Ontario, L8N4A6

  • Hamilton Health Sciences

    Hamilton, Ontario

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Vancouver Coastal Health (VCHRI/VCHA) - Diamond Health Care Centre and Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection

The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.

Being tested
Fresh FMT, Frozen-and-Thawed FMT
Keywords
Randomized, Double Blind, Fecal Transplant, Recurrent, Clostridium difficile infection, CDI, HBT, Diarrhea, Frozen HBT, Thawed HBT, Fecal Enema
Medical subject headings
Clostridium Infections, Recurrence, Diarrhea

What participants receive

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

  • Fresh FMTBiological

    Also called Fresh Fecal Transplantation (FMT)

    Participants will receive fresh FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed

  • Frozen-and-Thawed FMTBiological

    Also called Frozen-and-Thawed Fecal Transplantation (FMT)

    Participants will receive frozen-and-thawed FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed

Study groups in NCT01398969
Study groupRoleWhat they receive
Fresh FMTExperimentalParticipants in this arm will receive Fresh FMT via rectal administration. They will be followed for 13 weeks to assess the cure or recurrence of CDI. All other procedures between the two arms will be identical.
Receives: Biological: Fresh FMT
Frozen-and-Thawed FMTExperimentalParticipants in this arm will receive Frozen-and-Thawed FMT via rectal administration. They will be followed 13 weeks to assess the cure or recurrence of CDI. All other procedures between the two arms will be identical.
Receives: Biological: Frozen-and-Thawed FMT

What is being measured

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

  1. The evaluation of the safety of HBT

    Assessment for adverse reactions in each study group by history, physical examination, blood work at baseline, day 12, week 5 and at completion (week 13) of the study period.

    Measured: 13 Weeks post HBT

  2. To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT.

    Measured: 13 Weeks post HBT

Secondary outcomes (2)

  1. To determine the relapse rate of clinical and laboratory evidence of CDI within the 13-week study period in participants treated with fresh HBT in comparison to frozen thawed HBT.

    Measured: 13 Weeks post HBT

  2. Assessment of the functional health and well-being of patients

    Patients will be asked to fill in the self-administered Health Survey at baseline, week 5, week 13 and 1 year from last HBT

    Measured: Up to 1 year

Timeline

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

  1. First posted21 Jul 2011 (estimated)
  2. Study startJul 2012
  3. Primary completionJan 2015
  4. Study completionMar 2015

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants received either FMT or placebo to prevent further episode of CDI following FMT
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01398969
Sponsor's protocol ID
CDI.HBT.1
Status last verified
Mar 2015
First submitted
19 Jul 2011
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.

    PubMed 26757463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fresh FMT and Frozen-and-Thawed FMT in people with Clostridium Difficile Infection, run by McMaster University at 4 sites in Canada.

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

Who may be eligible to take part?

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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The evaluation of the safety of HBT (time frame: 13 Weeks post HBT). The study lists 2 primary outcomes in all. 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 NCT01398969, 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 7 Jun 2021.

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