Clinical Trials

FAIR

A Randomized Controlled Trial of Fecal Microbiota Transplant for AntIbiotic-Resistant Infections in Inpatients

Full Study Title

Indication

Seeking those with multiple drug resistant organisms (MDROs) and have taken antibiotics.

Research Program Study

Inpatient FMT via oral pill to treat mutiple drug resistant organism (MDRO) colonization and achieve 14 days with negative stool tests. Patients will be followed for 24 weeks (6 visits to The Emory Clinic and at least 6 phone calls). Participants are asked (but not required) to collect stool samples at 6 time points to be collected by courier from their home.

Inpatient adults with with colonization of a multi-drug resistant organism (MDRO) after infection

Patient Population

Clinical Program /

Mode of Treatment

Pill - FMT

PREMIX

A Pilot Study Using Fecal Microbiota Transplant in Renal Transplant Recipients to Eliminate Multidrug-Resistant Organism Colonization after Infection and Examine Gastrointestinal Carriage in a Randomized Placebo-Controlled Design

Full Study Title

Indication

Seeking those that have received a renal transplant and have a history of MDRO infection.

Research Program Study

Outpatient FMT via enema to treat multiple drug resistant organisms (MDRO's) in renal transplant patients and achieve 36 days with negative stool tests. Patients will be followed for 24 weeks (4 visits to The Emory Clinic and at least 6 phone calls). Participants are asked (but not required) to collect stool samples at 4 time points to be collected by courier from their home. Participants will be asked to keep a log of bowel movements for first few weeks and refrain from probiotics for the entirety of the study.

Adults with renal transplants and MDRO colonization

Patient Population

Clinical Program /

Mode of Treatment

Enema - FMT

REBIOTIX

A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection

Full Study Title

Indication

Seeking those with 3 or more CDI episodes with initial response to antibiotics (no diarrhea for 3 consecutive days) -OR- 2 severe CDI episodes resulting in hospitalization.

Research Program Study

Outpatient FMT via enema to treat recurrent CDI and achieve 8 weeks without symptoms.  Patients will be followed for 6 months (6 visits to The Emory Clinic and at least 5 phone calls).  Participants are asked (but not required) to collect stool samples at 8 time points to be collected by courier from their home. Participants will be asked to keep a log of bowel movements for first few weeks and refrain from probiotics for the entirety of the study.

Adults with recurrent C. difficle infection

Patient Population

Clinical Program /

Mode of Treatment

Enema - FMT

FINCH

A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection

Full Study Title

Indication

Seeking those with 3 episodes of CDI, with 2 episodes occurring within the previous 12 months (inclusive of the current episode) -OR- 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) AND 65 years of age or older.

Research Program Study

Outpatient FMT via capsules to treat recurrent CDI achieving 8 weeks without symptoms.  Patients will be followed for 6 months (7 visits to The Emory Clinic and at least 6 phone calls).  Participants will be asked to collect stool samples at 5 time points to be brought to office visits. Participants will be asked to keep a log of bowel movements for first few weeks and refrain from probiotics through week 8 of the study.

Adults with recurrent C. difficile infection

Patient Population

Clinical Program /

Mode of Treatment

Pill - FMT

SERES-012

SERES-012: ECOSPOR III: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adults who have Received Antibacterial Drug Treatment for Recurrent CDI (RCDI)

Full Study Title

Indication

Seeking those with >3 episodes of CDI within the previous 12 months, inclusive of the current episode, with documented history of > 2 episodes, inclusive of the current (qualifying) episode.

Research Program Study

Outpatient FMT via capsules to treat recurrent CDI and achieve 8 weeks without symptoms.  Patients will be followed for 6 months (4 visits to The Emory Clinic and at least 12 phone calls).  Participants will be asked to collect stool samples at 3 time points to be brought to next appointment. Participants will be asked to log all bowel movements and symptoms in a provided PDA for the duration of study and refrain from probiotics for the entirety of the study.

Adults with recurrent C. difficile infection

Patient Population

Clinical Program /

Mode of Treatment

Pill - FMT

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