Trial Outcomes & Findings for Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization (NCT NCT03061097)

NCT ID: NCT03061097

Last Updated: 2021-05-05

Results Overview

Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

Day 7 after randomization

Results posted on

2021-05-05

Participant Flow

We enrolled 78 patients across four nursing homes from July 10, 2017 to June 30, 2018. Of these 78, a total of 33 individuals were able to provide a stool sample of sufficient quantity to undergo procedures required for preparation of autologous FMT. As specified in the protocol, only participants that had stool processed into autologous FMT and subsequently received a course of antibiotics will undergo randomization. Out of the 33 eligible participants, a total of 7 were ultimately randomized

Of the 7 randomized participants, 3 participants withdrew prior to administration of FMT. A total of 26 enrolled participants were withdrawn or discontinued prior to randomization for reasons including: enrollment in hospice care, passing away from age-related comorbidities, withdrawal of consent, and non-compliance. The remaining 45 enrolled participants were removed at study closure since they did not meet criteria for randomization at the time of closure.

Participant milestones

Participant milestones
Measure	Treatment (Autologous Fecal Microbiota Preparation) Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Overall Study STARTED	4	3
Overall Study COMPLETED	4	0
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Autologous Fecal Microbiota Preparation) Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 Participants Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo n=3 Participants Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7 after randomization

Population: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.

Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.

Outcome measures

Outcome measures
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 Participants Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 28 after randomization

Number of patients with clearance of ARB among patients colonized at Day 28 by Polymerase Chain Reaction (PCR) assay or culture-based assay. ARBs are: Carbapenem-resistant Enterobacteriaceae (CRE) by PCR or culture assay, Extended spectrum beta-lactamase (ESBL)-producing organisms by PCR or culture assay, Vancomycin-resistant enterococci (VRE) by PCR or culture assay, or Clostridium difficile by PCR

Outcome measures

Outcome measures
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 Participants Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 3, Day 7, Day 28, Month 6

Number of participants who develop any ARB-associated infections following autologous FMT at Day 3, Day 7, Day 28, and Month 6

Outcome measures

Outcome measures
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 Participants Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Number of Participants Who Develop Any ARB-associated Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 28, Month 6

Number of participants with NIH Grade ≥2 adverse events (intermediate at Day 28 and long-term at Month 6) following autologous FMT.

Outcome measures

Outcome measures
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 Participants Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, Day 3, Day 7, Day 28

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)

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Autologous Fecal Microbiota Preparation)

Serious events: 4 serious events

Other events: 2 other events

Deaths: 2 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 participants at risk Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
General disorders Death	50.0% 2/4 • Number of events 2 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
General disorders Pyrexia	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Infections and infestations Pneumonia	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Infections and infestations Sepsis	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Renal and urinary disorders Urinary tract infection	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.

Other adverse events

Other adverse events
Measure	Treatment (Autologous Fecal Microbiota Preparation) n=4 participants at risk Participants randomized into the treatment arm will receive a single dose of autologous fecal microbiota preparation (auto-FMP) via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. Route of Administration: Enema Dosing Regimen: 125mL x 1 dose Autologous fecal microbiota transplant (Auto-FMP Enema): FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.	Placebo Participants randomized to the placebo arm will receive a single dose of placebo FMT via enema following an infectious episode requiring antibiotics, with follow-up at day 3, 7, 28, and 6 months. The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms. Placebo Enema Preparation: The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Reproductive system and breast disorders Benign prostatic hyperplasia	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.
Vascular disorders Hemorrhoids	25.0% 1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.	— 0/0 • Adverse events were collected for 6 months after randomization. For the placebo arm: All three (3) participants assigned to placebo arm withdrew post-randomization but pre-treatment administration. One (1) participant was outside of treatment window following antibiotic exposure and therefore no longer eligible to receive the treatment. Two (2) participants withdrew consent prior to administration of the intervention.

Additional Information

Majdi Osman, MD, MPH

Microbiome Health Research Institute

Phone: 617-575-2201

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place