PROTECT Study: Probiotic for Anal Pre-Cancer
This study, called PROTECT, is testing a probiotic called EXE-346 to see if it can treat high-grade squamous intraepithelial lesions (HSIL) in the anal area. HSIL are abnormal cell changes that can sometimes lead to anal cancer. You might be able to join if you are 21 or older, have biopsy-proven anal HSIL, and are participating in or screened for ULACNet-101 or ULACNet-102. The study aims to see if EXE-346 can make these lesions disappear and if it is safe. Researchers will also look at whether the probiotic helps clear the human papillomavirus (HPV) that causes these lesions. The study is currently unclear about its recruitment status.
- Study design
- This is a randomized, double-blinded, placebo-controlled study, meaning participants will be randomly assigned to receive either EXE-346 or a placebo (an inactive substance), and neither you nor your doctors will know which you are receiving. The study plans to enroll 90 participants.
- What's involved
- Participants will receive EXE-346 or placebo as a powder packet mixed with water for up to 3 months. You will have follow-up visits at 24 weeks and 36 weeks, and a High Resolution Anoscopy (HRA) procedure will be performed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 36 weeks after starting treatment to assess disease presence and any side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Joel Palefsky, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Proportion of participants with no disease presentUp to 36 weeks
No anal disease defined as complete regression of lesions as determined by examination of biopsies obtained at HRA
- Proportion of participants reporting treatment-emergent adverse eventsUp to 36 weeks
The frequency of participants reporting adverse events by group will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0