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NCT01905709 · ClinicalTrials.gov registry record · NA
Fecal Microbiota Transplantation for C Diff Infection
A NA study of Clostridium Difficile Infection, sponsored by Englewood Hospital and Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01905709 is a NA study of Clostridium Difficile Infection that is actively recruiting participants, run by Englewood Hospital and Medical Center. The registered enrollment target is 100 participants, below the 12,058-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01905709, a NA study of Clostridium Difficile Infection, is actively recruiting participants, sponsored by Englewood Hospital and Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that good bacteria (like that found in the stool from a healthy donor) attack Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile - and they attach to the surface of the colon lining, which prevents the Clostridium difficile toxin (poison) from attaching. FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of the patient with CDI during a colonoscopy. The method used to deliver the FMT will depend on individual characteristics of the subject and is at the discretion of the treating physician. FMT may be administered by the following methods. * Colonoscopy: This method allows full endoscopic examination of the colon and exclusion of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have an impact on subject's treatment or response to therapy. * Sigmoidoscopy: This method still allows infusion of the stool into a more proximal segment of the colon than an enema, but may not require sedation. This method may be beneficial in subjects who are elderly or multiparous and who may have difficulty retaining the material when given as enema. Sigmoidoscopic administration eliminates the additional risks associated with colonoscopy in subjects who may not have a clear indication for colonoscopy. * Retention enema: This method may be preferable in younger subjects who have already had recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in subjects with significant co morbidities and may not tolerate endoscopy. The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL, through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of colonoscopic delivery, the material will be delivered to the most proximal
Conditions Studied
Interventions
- BIOLOGICAL Human fecal matter
Study Locations (1)
New Jersey
- Englewood Hospital and Medical Center - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-07 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01905709
The ClinicalTrials.gov registry entry for NCT01905709 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,058-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower). The listed sponsor is Englewood Hospital and Medical Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 1 intervention - of which Human fecal matter is the first listed.
NCT01905709 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT01905709 about?
NCT01905709 is a clinical study titled "Fecal Microbiota Transplantation for C Diff Infection". The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that good bacteria (like that found in the stool from a healthy donor) attack Clostridium difficile in mul...
What is the current status of trial NCT01905709?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2013-07. Estimated completion is 2026-12.
What conditions does trial NCT01905709 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection.
What interventions are being tested in trial NCT01905709?
The interventions under investigation include: Human fecal matter (BIOLOGICAL).
Who is sponsoring clinical trial NCT01905709?
This trial is sponsored by Englewood Hospital and Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01905709 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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