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CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial

NCT06949800 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-01

No results posted yet for this study

Summary

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 the approach toward prevention of anal cancer in this population

Conditions

  • HSIL, High Grade Squamous Intraepithelial Lesion
  • HPV-Related Squamous Cell Carcinoma
  • Anal HSIL

Interventions

DRUG

EXE-346 Probiotic

Given as a single-dose, powder packet to mix with water

DRUG

Placebo

Given as a single-dose, powder packet to mix with water

PROCEDURE

Usual Care High Resolution Anoscopy (HRA)

Non-investigational HRA will be performed

Sponsors & Collaborators

Principal Investigators

  • Joel Palefsky, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-04-30
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06949800 on ClinicalTrials.gov