Further MT for Antibiotic-Resistant Bacterial Colonization

Conditions

• Intestinal Multi-drug Resistant Organism Colonization

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Microbiome Therapeutic — DRUG
  Participants will receive a single course of study treatment (IP, Encapsulated Microbiota): Orally delivered, non-frozen, encapsulated investigational intestinal microbiota, consisting of 16 capsules. One dose (8 capsules) is administered daily (QD) for 2 days. The capsules are to be taken orally with water on an empty stomach. Each dose will be taken approximately every 24 hours, with a minimum of 12 hours from the previous dose to a maximum of 36 hours. Both doses must be completed within the stated 36 hours ±12 hours. Depending on the time of the first dose, dosing may occur over 3 calendar days. A second cycle will begin, and a second treatment will be given if the participant is still MDRO positive on Day 14 of Cycle 1. If applicable, Cycle 2 will begin within 7 days of Day 14.
• Placebo — DRUG
  Participants will receive a single course of study treatment (Color-matched placebo capsules containing microcrystalline cellulose (MCC) powder), consisting of 16 capsules. One dose (8 capsules) is administered daily (QD) for 2 days. The capsules are to be taken orally with water on an empty stomach. Each dose will be taken approximately every 24 hours, with a minimum of 12 hours from the previous dose to a maximum of 36 hours. Both doses must be completed within the stated 36 hours ±12 hours. Depending on the time of the first dose, dosing may occur over 3 calendar days. A second cycle will begin, and a second treatment will be given if the participant is still MDRO positive on Day 14 of Cycle 1. If applicable, Cycle 2 will begin within 7 days of Day 14.

Study Details

The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection. Limited data from prior studies suggest that MT may be an effective treatment to reduce intestinal MDRO colonization Although shedding of MDROs from patients to their surrounding environment is a recognized pathway of transmission, the potential effect of MT on the transmission of MDRO to other patients in the hospital environment is unclear. This study will test the safety and efficacy of MT for this use in hospitalized patients. This study will also help design larger studies. The MT may help reduce MDROs that colonize the gut. By reducing colonization before infections happen, this could help doctors avoid using "last resort" antibiotics that can have serious side effects like kidney damage. The reduction in MDROs after MT was originally identified in patients treated with MT for recurrent Clostridioides difficile (often called "C. diff") diarrhea. It has been shown that a type of MT called fecal microbiota transplant (FMT) can eliminate both C. difficile and other resistant bacteria.

Key Dates

Start date

Apr 25, 2024

Status verified

May 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: microbiome therapeutic
  The study intervention is manufactured from a healthy screened donor as an investigational product (IP) and delivered via swallowed capsule after room reset of the patient's hospital room.
• Placebo Comparator: Placebo
  The control arm will remain in routine contact precautions per standard of care, take placebo capsules, and have a room reset.

Primary Outcome Measure

Change in stool MDRO colony-forming unit (CFU) density [ Time Frame: Day 0, day 14 of last cycle (each cycle is 14 days), and 28 weeks ]

Central Contacts

• Michael Woodworth, MD, MSc
  404-778-1691
  [email protected]
• Ella Wetzel, MS
  770-946-2109
  [email protected]

Locations (6)

Find similar trials in Atlanta, GA