Clostridium Difficile Clinical Trial
Official title:
Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis
This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for
CDI. The weight of the evidence in the literature suggests that FMT is the most effective
treatment for ambulatory outpatients affected by recurrent CDI who fail conventional
therapy.
The anticipated benefits to research patients enrolled in this study include resolution of
chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of
chronic recurrent CDI.
FMT involves the endoscopic instillation of freshly obtained stool with millions of live
bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure,
there is a risk of perforated viscous. This is very rare, but the risk is increased with
severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears
to be negligible.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02896244 -
AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
|
||
| Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
| Terminated |
NCT01048567 -
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|
Phase 2 | |
| Completed |
NCT01066221 -
Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile
|
N/A | |
| Not yet recruiting |
NCT03586206 -
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
|
||
| Completed |
NCT02563106 -
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
|
Phase 2 | |
| Completed |
NCT02207140 -
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
|
Phase 0 | |
| Completed |
NCT02857582 -
Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
|
Phase 2 | |
| Not yet recruiting |
NCT01942447 -
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
|
N/A | |
| Active, not recruiting |
NCT01703494 -
Fecal Transplant for Relapsing C. Difficile Infection
|
Phase 2 | |
| Completed |
NCT01813500 -
Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients
|
N/A | |
| Completed |
NCT01087892 -
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
|
N/A | |
| Suspended |
NCT00591357 -
Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy
|
Phase 4 | |
| Recruiting |
NCT00377078 -
Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.
|
N/A | |
| Completed |
NCT02254967 -
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
|
Phase 4 | |
| Terminated |
NCT01775397 -
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
|
Phase 4 | |
| Terminated |
NCT03617172 -
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
|
Phase 2 | |
| Recruiting |
NCT05622721 -
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
|
||
| Completed |
NCT02437487 -
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
|
Phase 2 | |
| Completed |
NCT02127814 -
Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile
|
N/A |