Trial Outcomes & Findings for Autologous Fecal Therapy (NCT NCT02046525)

Results Overview

Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

90 days after enrollment

Results posted on

2019-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Auto Fecal Microbitoa Therapy autologous fecal microbiota therapy Autologous fecal microbiota therapy	Saline Enema Saline enema Placebo: Saline enema
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Fecal Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auto Fecal Microbitoa Therapy n=5 Participants autologous fecal microbiota therapy Autologous fecal microbiota therapy	Saline Enema n=5 Participants Saline enema Placebo: Saline enema	Total n=10 Participants Total of all reporting groups
Age, Continuous	26 years n=5 Participants	34 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Non-white race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days after enrollment

Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome.

Outcome measures

Outcome measures
Measure	Auto Fecal Microbiota Therapy n=5 Participants autologous fecal microbiota therapy Autologous fecal microbiota therapy	Saline Enema n=5 Participants Saline enema Placebo: Saline enema
Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema	5 Participants	5 Participants

Adverse Events

Auto Fecal Microbitoa Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline Enema

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Auto Fecal Microbitoa Therapy n=5 participants at risk autologous fecal microbiota therapy Autologous fecal microbiota therapy	Saline Enema n=5 participants at risk Saline enema Placebo: Saline enema
Infections and infestations Ear infection	0.00% 0/5 • 90 days post-enema	20.0% 1/5 • Number of events 1 • 90 days post-enema
Infections and infestations H. pylori infection	20.0% 1/5 • Number of events 1 • 90 days post-enema	0.00% 0/5 • 90 days post-enema

Additional Information

Kimberly Reske, MPH

Washington University in St. Louis

Phone: 3147474041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place