The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation (GRAFT)
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|ClinicalTrials.gov Identifier: NCT03621657|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection C.Difficile Diarrhea CDI||Drug: Low Dose FMT Capsule DE Drug: Single Dose FMT Capsule DE Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a phase 2, double-blind, randomized, placebo-controlled trial assessing the effects of either daily (group 1) or one-time (group 2) oral FMT on the composition and function of gut microbiome compared to placebo (group 3) in a population of patients with a history of Clostridium difficile infection (CDI).|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Double-blind Placebo-controlled Trial to Determine if Fecal Microbiota Transplantation is Efficacious for Hospitalized Patients With C. Difficile Infection History During Antibiotic Treatment|
|Actual Study Start Date :||March 4, 2019|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Low dose FMT Capsule DE
FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic
Drug: Low Dose FMT Capsule DE
5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.
Other Name: FMT Capsule DE
Active Comparator: Single dose FMT Capsule DE
FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course.
Drug: Single Dose FMT Capsule DE
30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.
Other Name: FMT Capsule DE
Placebo Comparator: Placebo Oral Capsule
Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic
Drug: Placebo oral capsule
Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.
Other Name: Placebo
- Assess efficacy of oral FMT on composition and function of the gut microbiota compared to placebo. [ Time Frame: 60 days ]Assess microbial composition of stool using 16s targeted sequencing and shotgun metagenomics
- Comparison of treatment-related adverse events in the oral FMT regimens versus placebo. [ Time Frame: 60 days ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0, including serious adverse events, will be assessed. We will also assess proportion of newly diagnosed infectious diseases, which are considered adverse events of special interest (AESI) after randomization.
- Determine the rate of Clostridium difficile infection (CDI) during oral FMT regimens versus placebo [ Time Frame: 60 days ]Collection of CDI infection rates from baseline to end of study and comparison between both oral FMT groups versus placebo.
- Evaluate time to Clostridium difficile infection (CDI) and/or colonization with C. difficile. [ Time Frame: 60 days ]C. difficile colonization will be detected in stool samples submitted at baseline through end of study. If patients' become colonized, time from randomization to colonization is collected. Comparisons are made between the oral FMT groups and placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621657
|Contact: Ilsa A Gaulke, MSfirstname.lastname@example.org|
|Contact: Shelly L Zimbric, BSemail@example.com|
|United States, Wisconsin|
|University of Wisconsin Hospital & Clinics||Recruiting|
|Madison, Wisconsin, United States, 53794|
|Contact: Ilsa A Gaulke, MS 608-261-1044 firstname.lastname@example.org|
|Contact: Shelly L Zimbric, BS 608-265-8799 email@example.com|
|Principal Investigator: Nasia Safdar, MD PhD|