TerminatedPhase 1/2

Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)

Stopped: Low enrollment

United States10 participantsStarted 2019-01-11

Plain-language summary

Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be randomized at each site to receive either FMT by enema or placebo by enema in a 2:1 ratio. Study duration is 3 years, subject participation duration is approximately 1 year. The primary study objectives are: 1) to evaluate the safety of FMT(s) delivered by enema vs. placebo delivered by enema and 2) to determine efficacy of FMT delivered by enema vs. placebo delivered by enema.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Providing permission to access the medical record.
. Male or non-pregnant female 18 years or older at the time of enrollment.
. Able to provide signed and dated informed consent.
. = / \> 2 episodes of Clostridium difficile Associated Disease (CDAD) in the past 12 months, including the last episode if present at screening\*.
. Completed treatment course of at least 10 days of oral vancomycin, oral/IV metronidazole, or oral fidaxomicin for the most recent episode prior to enrollment.
. Controlled diarrheal symptoms (\<3 unformed stools per 24 consecutive hour period).
. Deemed likely to survive for 1 year after enrollment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a New Onset of Related Chronic Medical Condition After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 365

Number of Participants With a Serious Adverse Event (SAE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 365

Number of Participants With an Adverse Event (AE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 30

Number of Participants With Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI), After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 365

Proportion of Participants With Clinical Response (Defined as no Recurrence of Clostridium Difficile-Associated Diarrhea (CDAD))

Timeframe: Day 1 through Day 30

Trial details

NCT IDNCT03548051

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2021-01-13

Results submitted2021-12-30

View on ClinicalTrials.gov More Clostridial Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Providing permission to access the medical record.
. Male or non-pregnant female 18 years or older at the time of enrollment.
. Able to provide signed and dated informed consent.
. = / \> 2 episodes of Clostridium difficile Associated Disease (CDAD) in the past 12 months, including the last episode if present at screening\*.
. Completed treatment course of at least 10 days of oral vancomycin, oral/IV metronidazole, or oral fidaxomicin for the most recent episode prior to enrollment.
. Controlled diarrheal symptoms (\<3 unformed stools per 24 consecutive hour period).
. Deemed likely to survive for 1 year after enrollment.

What they're measuring

Number of Participants With a New Onset of Related Chronic Medical Condition After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 365

Number of Participants With a Serious Adverse Event (SAE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 365

Number of Participants With an Adverse Event (AE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)

Timeframe: Day 1 through Day 30

Timeframe: Day 1 through Day 365

Proportion of Participants With Clinical Response (Defined as no Recurrence of Clostridium Difficile-Associated Diarrhea (CDAD))

Timeframe: Day 1 through Day 30

Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria