A Phase 2 interventional study of LFMT and LSFF in Enterocolitis and Recurrent Clostridium Difficile Infection, sponsored by Dina Kao. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Dina Kao · Phase 2, Interventional, and Treatment
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
21 studies on the registry are indexed under Enterocolitis; 3 are open to participants now.
This study's enrollment of 11 is below the median of 75 across 14 interventional studies indexed under Enterocolitis.
Browse Enterocolitis studies →This is the only study on the registry with Dina Kao as lead sponsor.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lyophilized fecal microbiota transplant capsules
Biological: LFMT
Lyophilized sterile fecal filtrate capsules
Biological: LSFF
Lyophilized fecal microbiota transplant
Lyophilized sterile fecal filtrate
Resolution of RCDI
Proportion of subjects without RCDI
Time frame: 8 weeks
Resolution of RCDI
Proportion of subjects with sustained cure
Time frame: 24 weeks
Serious Adverse Events
Mortality directly attributable to CDI or treatment
Time frame: 8 weeks
Serious Adverse Events
Infection directly attributable to treatment
Time frame: 8 weeks
Minor Adverse Events
nausea
Time frame: 1 week
Minor Adverse Events
vomiting
Time frame: 1 week
Minor Adverse Events
abdominal pain
Time frame: 1 week
Difficulty in swallowing capsules
Reported by subjects as ranging between none, moderate or severe
Time frame: 1 week
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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