NCT05938465 · Exegi Pharma, LLC
Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
(PROF)
What this study is about
The aim of this study is to assess the safety and preliminary effectiveness of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.
View original scientific description
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.
Interventions
BIOLOGICAL
EXE-346
EXE-346 contains a proprietary, fixed-dose, lyophilized blend of 8 strains of gram positive, lactic acid bacteria. EXE-346 excipients are maltose and silicon dioxide.
OTHER
Placebo
Placebo contains excipients maltose and silicon dioxide.
Primary outcome measures
Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: 4 weeks
To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of treatment emergent adverse events (TEAE) and serious adverse events (SAE).
Phase 1b: Number of Participants with Abnormal Physical Examinations
Time frame: 4 weeks
To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 1b: Number of Participants with Abnormal Vital Signs
Time frame: 4 weeks
To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.
Phase 1b: Number of Participants with Abnormal Safety Labs
Time frame: 4 weeks
To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 1b: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)
Time frame: 4 weeks
To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).
Phase 2: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: 8 weeks
To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of TEAEs and SAEs.
Phase 2: Number of Participants with Abnormal Physical Examinations
Time frame: 8 weeks
To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 2: Number of Participants with Abnormal Vital Signs
Time frame: 8 weeks
To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.
Phase 2: Number of Participants with Abnormal Safety Labs
Time frame: 8 weeks
To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 2: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)
Time frame: 8 weeks
To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).
Phase 2: Change in Total Daily Bowel Movement Frequency
Time frame: 8 weeks
To assess the efficacy of EXE-346 to reduce the total daily bowel movement frequency using change in average daily bowel movement frequency from baseline to each post-baseline week
Phase 2 Open Label: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: 8 weeks
To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of TEAEs and SAEs.
Phase 2 Open Label: Number of Participants with Abnormal Physical Examinations
Time frame: 8 weeks
To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 2 Open Label: Number of Participants with Abnormal Vital Signs
Time frame: 8 weeks
To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.
Phase 2 Open Label: Number of Participants with Abnormal Safety Labs
Time frame: 8 weeks
To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.
Phase 2 Open Label: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)
Time frame: 8 weeks
To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- - Phase 1b Only 1. Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening. 2. Subject has had a documented pouchoscopy within 12 months prior to screening. 3. Subject or the subject's legally authorized representative is willing and able to provide written informed consent prior to the initiation of any study-related procedures. 4. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -13 to 0). Inclusion Criteria - Phase 2 Double-Blinded Part Only 1. Subject is a male or female and is aged 18 years or older at screening. 2. Subject is willing and able to provide written informed consent prior to the initiation of any study-related procedures. 3. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly co
Where
- Los Angeles, California
- Jacksonville, Florida
- Grand Rapids, Michigan
- Rochester, Minnesota
- St Louis, Missouri
- New York, New York
- Chapel Hill, North Carolina
- Hershey, Pennsylvania
Collaborators
The Emmes Company, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations