Microbiome therapy for antibiotic-resistant bacterial colonization in hospitalized patients
A Randomized Controlled Trial to Further Microbiota Therapy for Antibiotic-Resistant Bacterial Colonization.
This study is testing a new treatment using microbiome therapy to see if it can help hospitalized patients with antibiotic-resistant infections by reducing harmful bacteria in their gut.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Atlanta, Georgia and 5 other locations) |
| Trial ID | NCT05835206 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of microbiome therapies (MT) in treating patients with multi-drug resistant organism (MDRO) colonization following an infection. It is a phase 2, randomized, placebo-controlled, double-blind trial involving 40 adult inpatients who are colonized with specific MDROs. Participants will be assigned to either receive the microbiome therapy or a placebo, with the aim of reducing intestinal MDRO colonization and potentially decreasing the need for last-resort antibiotics. The study also seeks to understand the impact of MT on environmental contamination within the hospital setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adult inpatients aged 18 and older who are colonized with specific multi-drug resistant organisms.
Not a fit: Patients who are not colonized with the targeted multi-drug resistant organisms or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the prevalence of antibiotic-resistant bacteria in patients, leading to better health outcomes and reduced reliance on harmful antibiotics.
How similar studies have performed: While limited data exists, prior studies suggest that microbiome therapies may effectively reduce MDRO colonization, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be able to (or have an available Legally Authorized Representative who is able to) understand and be willing to sign a written informed consent document. * Be at least 18 years old at the time of consent. * Be able and willing to comply with all study protocol requirements, including the ability to swallow capsules. * Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Acinetobacter, and/or MDR Pseudomonas) as detected by bacterial culture of stool or perianal/rectal swab. * Be able and willing to discontinue systemic antibiotics at least one day prior to study Day 0 and for as long as medically able to do so throughout the study. * Be willing to discontinue probiotics or other microbiota restoration therapies at least one day prior to study Day 0 and for the duration of study participation. * The effects of the IP on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Exclusion Criteria: * Be pregnant, breastfeeding, lactating, or planning a pregnancy during the study duration (through 4 weeks after the last dose of investigational product, or IP), if women of childbearing potential (WOCBP). * Have known uncontrolled intercurrent illness(es) such as, but not limited to Symptomatic congestive heart failure, acute coronary syndrome, cardiac arrhythmia, untreated in situ colorectal cancer, toxic megacolon or ileus, use of medications that decrease GI motility and increase broncho-aspiration risk (e.g. loperamide, diphenoxylate/atropine, cholestyramine), or history of positive stool studies or cultures in the last 30 days for ova, parasites, Salmonella, Shigella, Campylobacter, or other enteropathogens other than those detected by screening MDRO stool cultures for inclusion. * Have any other intercurrent acute illness that in the opinion of the investigator will preclude the subject from entering the study. * Be on systemic antibiotics for any reason other than if the MDRO infection was recent or the potential participant is still taking antibiotics for target MDRO at the time of screening. If the latter, the participant must be able (in the opinion of their treating providers) to complete the planned antibiotic course by study Day -1. * Have a compromised immune system, defined as AIDS with a cluster of differentiation 4 (CD4)+ T-cell count \<200, history of documented absolute neutrophil count (ANC) \<1,000 neutrophils/mL within 14 days of D0, active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months of enrollment or history of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year. * Have a history of significant food allergy that led to anaphylaxis or hospitalization. * Have a life expectancy of 24 weeks or less * Have any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to known active intravenous drug or alcohol abuse, psychiatric illness, and/or social situation * Participated in an investigational study that also meets one of the following criteria: Received an interventional agent (drug, device, or procedure) in the last 28 days or enrollment in any other interventional study for MDROs.
Where this trial is running
Atlanta, Georgia and 5 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory Rehabilitation Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory University Clinical Research Network — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital (EUH) — Atlanta, Georgia, United States (Recruiting)
- Emory University at Wesley Woods Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory Johns Creek Hospital — Johns Creek, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Michael Woodworth, MD, MSc — Emory University
- Study coordinator: Michael Woodworth, MD, MSc
- Email: mwoodwo@emory.edu
- Phone: 404-778-1691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.