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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06949800
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EXE-346 Probiotic — DRUG
    Given as a single-dose, powder packet to mix with water
  • Placebo — DRUG
    Given as a single-dose, powder packet to mix with water
  • Usual Care High Resolution Anoscopy (HRA) — PROCEDURE
    Non-investigational HRA will be performed

Study Details

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

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Blinded: EXE-346 probiotic
    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.
  • Placebo Comparator: Blinded: Placebo
    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.

Primary Outcome Measure

Proportion of participants with no disease present [ Time Frame: Up to 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Ross Jamison
[email protected]
415-353-9042
[email protected]
877-827-3222

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By research site
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