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New treatment option for Intestinal Multi-drug Resistant Organism Colonization
Official title Further MT for Antibiotic-Resistant Bacterial Colonization
ClinicalTrials.gov ID: NCT05835206
What this study is testing
What is Microbiome Therapeutic?
Microbiome Therapeutic is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for intestinal multi-drug resistant organism colonization.
Also referred to as Intervention Group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to (or have an available Legally Authorized Representative who is able to) understand and be willing to sign a written informed consent...
- 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...
- 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...
You likely can't join if
- Be pregnant, breastfeeding, lactating, or planning a pregnancy during the study duration (through 4 weeks after the last dose of investigational...
- Have known uncontrolled intercurrent illness(es) such as, but not limited to Symptomatic congestive heart failure, acute coronary syndrome, cardiac...
- 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...
- Have a compromised immune system, defined as AIDS with a cluster of differentiation 4 (CD4)+ T-cell count \<200, history of documented absolute...
- Have a history of significant food allergy that led to anaphylaxis or hospitalization.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Participated in an investigational study that also meets one of the following criteria: Received an treatment agent (drug, device, or procedure) in the last 28 days or enrollment in any other treatment study for MDROs.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Johns Creek, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Johns Creek, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.