NCT06949800View on ClinicalTrials.gov

"PROTECT Study, PRObiotics to TrEat Anal preCancer Trial"

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
HSIL, High Grade Squamous Intraepithelial LesionHPV-Related Squamous Cell CarcinomaAnal 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

Trial Locations (2)

14080

Instituto Nacional de Cancerologia, Tlalpan

00936

University of Puerto Rico Comprehensive Cancer Center, San Juan

Sponsors

Collaborators (1)

Exegi Pharma, LLC
All Listed Sponsors
collaborator

Exegi Pharma, LLC

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

University of California, San Francisco

OTHER

NCT06949800 - "PROTECT Study, PRObiotics to TrEat Anal preCancer Trial" | Biotech Hunter | Biotech Hunter