Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization (RACE)
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|ClinicalTrials.gov Identifier: NCT03061097|
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Resistant Strain||Biological: Autologous fecal microbiota transplant Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Treatment (autologous fecal microbiota preparation)
Autologous treatment preparation: Patient stool will be collected and processed into an auto-fecal microbiota preparation (FMP) formulation. In this treatment arm, the auto-FMP will be administered to the participant following an infectious episode requiring antibiotics.
V-A Auto-FMP Enema (125 mL):
Route of Administration: Enema nozzle will be inserted into rectum and contents expelled into the distal colon. Target dwell time is 1 hour. Participants will lie in the left lateral decubitas position but if mobility permits will rotate to supine and right lateral decubitus position.
Dosing Regimen: 125mL x 1 dose
Biological: Autologous fecal microbiota transplant
Fecal Microbiota Transplant (FMT) FMT is the process by which processed donor microbiota material is transplanted into recipients, by either upper or lower gastrointestinal delivery. The aim is to reconstitute the normal intestinal microbial flora in recipients. FMT can be administered by either enema or capsule depending on eligibility criteria. In this study, the fecal microbiota preparation will be made from the participant's own stool (autologous FMT).
Placebo Comparator: Placebo
Participants randomized to the placebo arm will receive a placebo FMT via enema. The placebo enema preparation interventional enema in appearance.
The placebo enema preparation will be comprised of Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), and 8-12 drops brown food coloring (<1%), to prevent unmasking of the trial arms.
Placebo FMT material delivered via enema.
- Safety (short-term) defined as absence of NIH Grade ≥2 adverse events including IND safety reporting criteria [ Time Frame: 7 days ]Safety (short-term) at day 7 defined as absence of NIH Grade ≥2 adverse events including IND safety reporting criteria
- Microbiome Disruption Index (MDI) [ Time Frame: Day 0, Day 3, Day 7, and Day 28 ]Microbiome disruption indices (16S rRNA sequencing): MDI-community and MDI-species at baseline (pre-infection on the date of stool collection), post-antibiotics on the intervention/placebo date (Day 0, Day 3, Day 7, and Day 28). MDI will be applied to pre- and post-intervention communities in comparison to baseline and reference communities.
- ARB Colonization [ Time Frame: Day 0, Day 3, Day 7, and Day 28 ]Rate of ARB clearance among patients with ARB colonization
- ARB-associated clinical infectionDay 3, Day 7, Day 28, and Month 6. [ Time Frame: Day 3, Day 7, Day 28, and Month 6 ]Composite endpoint for presence of any ARB-associated clinical infection
- Safety (intermediate and long-term) defined as NIH Grade ≥2 adverse events. [ Time Frame: Day 28 and Month 6 ]Safety (intermediate at Day 28 and long-term at Month 6) defined as NIH Grade ≥2 adverse events.
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): NCT03061097
|United States, Massachusetts|
|The Edgar P Benjamin Health Care Center|
|Boston, Massachusetts, United States, 02120|
|Sherrill House Inc.|
|Jamaica Plain, Massachusetts, United States, 02130|
|Marian Manor Nursing Home|
|South Boston, Massachusetts, United States, 02127|
|Principal Investigator:||Zain Kassam, MD||Microbiome Health Research Institute, (d/b/a OpenBiome)|