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A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization
Phase 2 trial testing Encapsulated fecal microbiota preparation in Antibiotic Resistant Strain in 9 participants. Completed in 26 February 2019.
| Lead sponsor | Microbiome Health Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 17 August 2017 |
| Primary completion | 19 September 2018 |
| Estimated completion | 26 February 2019 |
| Sites | 2 locations across United States |
Microbiome Health Research Institute
18 and older, any sex, with Antibiotic Resistant Strain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 1 | |
| Placebo: Encapsulated Placebo | 1 |
Percentage of participants with an adverse event (AE); severe adverse event (SAE); and newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through Day 10 (± 3 days) after randomization.
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 3 | |
| Placebo: Encapsulated Placebo | 5 |
Percentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 0 | |
| Placebo: Encapsulated Placebo | 0 |
Percentage of participants with VRE decolonization among immunocompromised patients
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 1 | |
| Placebo: Encapsulated Placebo | 1 |
Percentage of participants with an adverse event (AE)
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 3 | |
| Placebo: Encapsulated Placebo | 5 |
Percentage of participants with a serious adverse event (SAE)
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 0 | |
| Placebo: Encapsulated Placebo | 0 |
Percentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 0 | |
| Placebo: Encapsulated Placebo | 0 |
Percentage of participants with a Serious Adverse Event (SAE)
| Group | Value | 95% CI |
|---|---|---|
| Active: Encapsulated Fecal Microbiota Preparation | 2 | |
| Placebo: Encapsulated Placebo | 1 |
Time frame: Adverse events were collected for 6 months after randomization,. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Active: Encapsulated Fecal… | Placebo: Encapsulated Plac… |
|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | — | — |
| Congestive Heart Failure | Cardiac disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Reaction | System | Active: Encapsulated Fecal… | Placebo: Encapsulated Plac… |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — |
| Abdominal distention | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Osteoporosis | Musculoskeletal and connective tissue disorders | — | — |
| Dry Eye | Eye disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Discolored stool | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Ear pain | Ear and labyrinth disorders | — | — |
| Throat pain | Gastrointestinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Loss of appetite | General disorders | — | — |
| Elevated liver function tests | Hepatobiliary disorders | — | — |
| Polymyalgia rheumatica | Immune system disorders | — | — |
| CMV re-activation | Infections and infestations | — | — |
| Gout | Metabolism and nutrition disorders | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — |
| Acute sinusitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Cholangitis, Congestive Heart Failure, Jaundice.
Data from ClinicalTrials.gov NCT03063437 adverse events section.
The objective of this study is to provide preliminary insight into the safety and efficacy of fecal microbiota transplantation (FMT) for the eradication of gastrointestinal carriage of vancomycin-resistant Enterococcus.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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