What side effects are associated with this type of intervention?

Common treatments for ileal pouch include antibiotics, probiotics, and fecal microbiota transplantation (FMT). Antibiotics can cause side effects such as nausea, diarrhea, and allergic reactions. Probiotics are generally well-tolerated but may cause mild gastrointestinal symptoms like gas and bloating. FMT, which involves transferring stool from a healthy donor to the patient, can lead to side effects such as abdominal discomfort, diarrhea, and, in rare cases, infections. Live biotherapeutics like EXE-346, which aim to modulate gut microbiota, are still under study, but potential side effects may include gastrointestinal symptoms similar to those seen with probiotics and FMT.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved live biotherapeutic products for the treatment of ileal pouch conditions. However, treatments that modulate gut microbiota, such as probiotics and fecal microbiota transplantation (FMT), have been explored in clinical settings for related conditions like pouchitis. For instance, Clostridium butyricum MIYAIRI has been studied for its potential to prevent pouchitis in patients with ulcerative colitis. These treatments aim to restore a healthy balance of gut bacteria, similar to the investigational EXE-346.

What other types of research exist?

Promising alternatives to EXE-346 for ileal pouch patients include: 1) Bifidobacterium longum 536 (BB536), which has shown efficacy in inducing remission in ulcerative colitis, potentially benefiting IPAA patients. 2) Sucralfate enemas, which reduce oxidative tissue damage and preserve mucosal integrity. 3) Curcumin enemas, which have demonstrated anti-inflammatory effects in experimental models of diversion colitis. 4) High-concentration dextrose spray, used endoscopically to treat bleeding diversion pouchitis. These treatments offer novel approaches to managing symptoms and improving quality of life for ileal pouch patients.

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Live Biotherapeutic

EXE-346 for Ileal Pouch (PROF Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Exegi Pharma, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

PROF Trial Summary

This trial aims to study the safety and potential benefits of a live biotherapeutic, EXE-346, for patients with IPAA and reduce their bowel movements, improving their quality of life.

Who is the study for?

Adults with an ileal pouch-anal anastomosis (IPAA) experiencing at least 10 bowel movements daily, who've kept a diary of this during screening. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include long-term NSAID users, those with certain pouch complications or infections, recent biologic or steroid treatments, significant past illnesses like cancer within 5 years (except some skin cancers), and severe kidney issues.Check my eligibility

What is being tested?

The trial is testing EXE-346, a live biotherapeutic product against a placebo to see if it can reduce the frequency of bowel movements in patients with IPAA. The goal is to improve their quality of life by potentially normalizing bowel function.See study design

What are the potential side effects?

While specific side effects for EXE-346 are not listed here, common side effects from live biotherapeutics may include digestive discomfort, bloating, gas, and potential allergic reactions for those sensitive to the components.

PROF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Phase 1b: Number of Participants with Abnormal Physical Examinations

Phase 1b: Number of Participants with Abnormal Safety Labs

+13 more

Secondary outcome measures

Phase 1b: Bowel Movement Consistency

Phase 1b: Bowel Movement Frequency

Phase 1b: Nighttime Awakening Frequency

+2 more

PROF Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 2: Active ArmExperimental Treatment1 Intervention

EXE-346 live biotherapeutic product, 1500x10^9 CFU BID, 8 weeks

Group II: Phase 2 Open Label Extension (optional)Experimental Treatment1 Intervention

EXE-346 live biotherapeutic product, 1500x10^9 CFU BID, 8 weeks

Group III: Phase 1b Open LabelExperimental Treatment1 Intervention

EXE-346 live biotherapeutic product, 1500x10^9 colony forming units (CFU) twice daily (BID), 4 weeks

Group IV: Phase 2: Placebo ArmPlacebo Group1 Intervention

Powder containing same inactive ingredients as EXE-346 but none of the active ingredients, BID, 8 weeks

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ileal pouch disorders, such as pouchitis, often include antibiotics like metronidazole and ciprofloxacin, which reduce harmful bacteria, and probiotics like VSL#3, which introduce beneficial bacteria to restore gut microbiota balance. The live biotherapeutic EXE-346, similar to probiotics, aims to modulate the gut microbiota by promoting a healthy bacterial environment. This is crucial for ileal pouch patients as an imbalanced microbiota can lead to inflammation, increased bowel movements, and reduced quality of life. By restoring a healthy microbiota, these treatments help manage symptoms and improve overall gut health.

Pouchitis: diagnosis and management.Randomized controlled trials in pouchitis.

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Who is running the clinical trial?

Exegi Pharma, LLCLead Sponsor

2 Previous Clinical Trials

173 Total Patients Enrolled

The Emmes Company, LLCIndustry Sponsor

146 Previous Clinical Trials

1,051,771 Total Patients Enrolled

Melody Khorrami, PharmD, RPhStudy DirectorExegi Pharma, LLC

Media Library

EXE-346 (Live Biotherapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT05938465 — Phase 1 & 2

Ileal Pouch Research Study Groups: Phase 1b Open Label, Phase 2: Active Arm, Phase 2: Placebo Arm, Phase 2 Open Label Extension (optional)

Ileal Pouch Clinical Trial 2023: EXE-346 Highlights & Side Effects. Trial Name: NCT05938465 — Phase 1 & 2

EXE-346 (Live Biotherapeutic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938465 — Phase 1 & 2

~21 spots leftby Jan 2025

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