Probiotics for Anal Intraepithelial Lesions
(ULACNet102 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new probiotic, EXE-346, can help treat anal high-grade squamous intraepithelial lesions (HSIL) in people living with HIV. These lesions pose a risk because they can lead to anal cancer. Participants will receive either the probiotic or a placebo for three months, with follow-ups to assess the treatment's effectiveness. This study suits individuals with biopsy-confirmed anal HSIL who have been on antiretroviral therapy for at least three months. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires participants to be on an effective antiretroviral therapy (ART) regimen for at least three months before joining. However, if you are taking long-term NSAIDs or have started antibiotics recently, you may need to stop or adjust those medications. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the study team.
Is there any evidence suggesting that EXE-346 Probiotic is likely to be safe for humans?
Research shows that the EXE-346 probiotic is generally safe for people. One study found it safe for patients with certain bowel surgeries, even at high doses of 3,000 billion live probiotics per day, indicating it is well-tolerated. Another study examined its effect on reducing bowel movements and assessed the safety and early effectiveness of EXE-346.
Although these studies did not specifically examine anal lesions, their results contribute to understanding the probiotic's safety. As this trial is in an early stage, researchers will carefully monitor for any side effects, but the current data is reassuring.12345Why do researchers think this study treatment might be promising?
EXE-346 is unique because it uses probiotics to potentially treat anal intraepithelial lesions, which is a novel approach compared to the standard treatments like surgical removal or topical therapies. Unlike these existing options, EXE-346 is designed to be taken orally, offering a less invasive alternative. Researchers are excited because probiotics might help modulate the immune system or the microbiome in a way that could prevent lesion progression, potentially offering a safer and simpler treatment option.
What evidence suggests that EXE-346 probiotic might be an effective treatment for anal HSIL in persons with HIV?
Research shows that EXE-346, a type of probiotic, might help treat certain anal lesions in people with HIV. These lesions, known as high-grade squamous intraepithelial lesions (HSIL), are linked to the human papillomavirus (HPV). Probiotics are known to improve gut health, which might help manage these lesions. Earlier studies examined the safety and effectiveness of EXE-346 in easing bowel problems, suggesting it could also help with anal issues. In this trial, participants will receive either EXE-346 or a placebo to evaluate its effectiveness. While research on EXE-346 continues, it may enhance the body’s natural defenses, offering a promising way to reduce HSIL and possibly prevent anal cancer in people with HIV.12456
Who Is on the Research Team?
Joel Palefsky, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people with HIV who have a specific type of anal lesion linked to cancer risk. They must have been on effective HIV treatment for at least three months, have a low viral load, and their immune system should be relatively strong. Participants need to have consented to previous related studies or screenings and should not have had all lesions removed already.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sachets of EXE-346 or placebo, consumed orally twice per day for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 24 and 36 weeks
Extension
Participants with active HSIL at week 36 may be treated with non-investigational, standard of care, hyfrecation
What Are the Treatments Tested in This Trial?
Interventions
- EXE-346 Probiotic
Trial Overview
The CASCADE 2002 study tests if EXE-346 Probiotic can treat severe anal lesions in HIV-positive individuals better than usual care alone. Half the participants will receive the probiotic while the other half will get a placebo, alongside regular high-resolution anoscopy monitoring.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be blinded and stratified on gender and according to hrHPV status (HPV16 present or absent in baseline swab). After confirmation of biopsy-proven HSIL, participants will receive sachets of EXE-346 or placebo, with the contents suspended in water and consumed orally twice per day for 3 months (12 weeks) with follow-up visits at 24 and 36 weeks. Participants will undergo High resolution anoscopy (HRA) as a safety check at Visit 3 (12 weeks) and at Visit 4 (24 weeks) to ensure HRA has not progressed to cancer. Biopsies will only be performed if there is any concern for progression. Participants with active HSIL at week 36 will be treated with non-investigational, standard of care, hyfrecation as soon as possible, but within 8 weeks.
Participants will be blinded and stratified on gender and according to hrHPV status (HPV16 present or absent in baseline swab). After confirmation of biopsy-proven HSIL, participants will receive sachets of EXE-346 or placebo, with the contents suspended in water and consumed orally twice per day for 3 months (12 weeks) with follow-up visits at 24 and 36 weeks. Participants will undergo High resolution anoscopy (HRA) as a safety check at Visit 3 (12 weeks) and at Visit 4 (24 weeks) to ensure HRA has not progressed to cancer. Biopsies will only be performed if there is any concern for progression. Participants with active HSIL at week 36 will be treated with non-investigational, standard of care, hyfrecation as soon as possible, but within 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Exegi Pharma, LLC
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Study of EXE-346 Live Biotherapeutic to Reduce High ...
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346 which may reduce bowel movement frequency in patients with an ...
PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying ...
EXE-346 - Drug Targets, Indications, Patents
A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an Ileal ...
4.
biospace.com
biospace.com/press-releases/exegi-pharma-positive-topline-results-in-exe-346-prof-phase-1b-studyExeGi Pharma Positive Topline Results in EXE-346 PROF ...
PROF study demonstrates safety of EXE-346 drug product in pouch anastomosis patients at 3,000 billion live probiotic consumption per day for ...
Study of EXE-346 Live Biotherapeutic to Reduce High ...
The purpose of this study is to assess the safety of EXE-346 after 4 weeks of treatment in subjects with an Ileal-Pouch Anal Anastomosis (IPAA) and high bowel ...
Study of EXE-346 Live Biotherapeutic to Reduce High ...
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 ...
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