Infectious Disease of Digestive Tract
Conditions
Keywords
Fecal microbiota therapy
Brief summary
Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal microbiome after antimicrobial exposure.
Interventions
BIOLOGICALAutologous fecal microbiota therapy
OTHERPlacebo
Saline enema
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Adults 18-70 years of age-
Exclusion criteria
history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or risk of becoming pregnant during the study period; gastroenteritis in the last 3 months; incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon; unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change in diet or medications, or elective surgery, during the study period; or a history of an intestinal disorder -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auto Fecal Microbitoa Therapy autologous fecal microbiota therapy
Autologous fecal microbiota therapy | 5 |
| Saline Enema Saline enema
Placebo: Saline enema | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Saline Enema | Total | Auto Fecal Microbitoa Therapy |
|---|---|---|---|
| Age, Continuous | 34 years | 31 years | 26 years |
| Race/Ethnicity, Customized Non-white race | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 1 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema
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.
Time frame: 90 days after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Auto Fecal Microbiota Therapy | Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema | 5 Participants |
| 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 |