National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 99, any sex, with Clostridial Infection or Dysbiosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a New Onset of Related Chronic Medical Condition After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)Primary· Day 1 through Day 365
New onset of related chronic medical conditions (NOCMCs) through 365 days after completing treatment for recurrent CDAD were reported. NOCMCs were defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study agent, that is expected to continue for at least 3 months and requires continued health care intervention.
Group
Value
95% CI
FMPE Group
0
FMPP Group
0
Number of Participants With a Serious Adverse Event (SAE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)Primary· Day 1 through Day 365
SAEs included any adverse event or suspected adverse reaction which, in the view of the investigator or sponsor, resulted in any of the following: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a congenital anomaly/birth defect, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life function.
Group
Value
95% CI
FMPE Group
3
FMPP Group
2
Number of Participants With an Adverse Event (AE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)Primary· Day 1 through Day 30
Adverse events were defined as any noxious, pathologic, or unintended change in anatomic, physiologic, or metabolic functions, as indicated by physical signs, symptoms, and/or laboratory changes occurring in any phase of the clinical trial, regardless of their relationship to investigational product.
Group
Value
95% CI
FMPE Group
4
FMPP Group
0
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)Primary· Day 1 through Day 365
Adverse Events of Special Interest were defined as newly acquired transmissible infectious agents or infectious diseases related to study product and the following agents: HIV type 1 and 2, Hepatitis A, B, C, Treponema pallidum, HTLV-1, -2, Cyclospora, Salmonella, Shigella, Campylobacter, E. coli 0157:H7, Shiga-toxin producing E. coli, Ova and enteric parasites including Isospora, Vancomycin-resistant Enterococcus (VRE), extended spectrum beta-lactamase (ESBL), carbapenemase producing gram-negative rods, methicillinresistant Staphylococcus aureus (MRSA), Helicobacter pylori, Rotavirus, Adenovi
Group
Value
95% CI
FMPE Group
0
FMPP Group
0
Proportion of Participants With Clinical Response (Defined as no Recurrence of Clostridium Difficile-Associated Diarrhea (CDAD))Primary· Day 1 through Day 30
Clinical response was defined as those subjects who have no recurrence of CDAD through Day 30 after completing treatment for recurrent CDAD. CDAD was defined as bowel movements as determined by \>=3 unformed stools (soft or watery) within 24 consecutive hours and a positive PCR test for Clostridium difficile.
Group
Value
95% CI
FMPE Group
0.80
0.38 – 0.96
FMPP Group
0.75
0.30 – 0.95
Number of Recurrences of Clostridium Difficile-Associated Diarrhea (CDAD) After Completing Treatment for Recurrent CDADSecondary· Day 1 through Day 30
Recurrence was defined as the re-establishment of diarrhea (frequency of passed unformed stools, \>=3 unformed stools within 24 consecutive hours) with a positive PCR test for C. difficile.
Group
Value
95% CI
FMPE Group
0.2
± 0.4
FMPP Group
0.3
± 0.5
Number of Recurrences of Clostridium Difficile-Associated Diarrhea (CDAD) After Completing Treatment for Recurrent CDADSecondary· Day 1 through Day 60
Recurrence was defined as the re-establishment of diarrhea (frequency of passed unformed stools, \>=3 unformed stools within 24 consecutive hours) with a positive PCR test for C. difficile.
Group
Value
95% CI
FMPE Group
0.2
± 0.4
FMPP Group
0.3
± 0.5
Proportion of Participants With Sustained Clinical ResponseSecondary· Day 1 through Day 60
Sustained clinical response is defined as those subjects who responded by Day 30 with no recurrence of CDAD through Day 60 after randomization.
Group
Value
95% CI
FMPE Group
0.80
0.38 – 0.96
FMPP Group
0.75
0.30 – 0.95
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)Secondary· Day 1 through Day 60 visit windows reported as Weeks 1 through 8, respectively
The time (in weeks) until first CDAD recurrence was calculated as time from randomization to the end of the interval of ascertainment. Participants without a recurrence were censored at their last known contact date or their Day 60 visit, whichever occurred first.
Week 1 at Risk
Group
Value
95% CI
FMPE Group
5
FMPP Group
4
Week 1 with CDAD
Group
Value
95% CI
FMPE Group
0
FMPP Group
0
Week 1 Censored
Group
Value
95% CI
FMPE Group
0
FMPP Group
0
Week 2 at Risk
Group
Value
95% CI
FMPE Group
5
FMPP Group
4
Week 2 with CDAD
Group
Value
95% CI
FMPE Group
1
FMPP Group
1
Week 2 Censored
Group
Value
95% CI
FMPE Group
0
FMPP Group
0
Week 3 at Risk
Group
Value
95% CI
FMPE Group
4
FMPP Group
3
Week 3 with CDAD
Group
Value
95% CI
FMPE Group
0
FMPP Group
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS)
· Phase 1
· not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of
· Phase 1, PHASE2
· not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 2 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03548051.