Status:
UNKNOWN
Application of Oral Bacteriotherapy to Promote Anal HPV Clearance in HIV Positive Individuals
Lead Sponsor:
University of Roma La Sapienza
Conditions:
HIV
Anal Dysplasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Published studies suggest that oral probiotic intake can promote the clearance of HPV genital infection and HPV related genital dysplasia in HIV negative women. In the present randomized, double blind...
Detailed Description
Squamous Cell Carcinoma (SCC) of the anus and the anal canal represents a major concern for the HIV infected population, with incidence rates in the different sub populations (women, men, MSM) that ar...
Eligibility Criteria
Inclusion
- HIV infected individuals \>18 years old
- stable and effective antiretroviral therapy since at least 12 months
- HPV associated anal dysplasia
- patient willing to provide written informed consent
Exclusion
- impossibility to intake the investigational product
- any contraindication to blood sampling
- inflammatory bowel disease
- use of antibiotics during the 3 months prior to the enrollment in the study
- pregnancy
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04099433
Start Date
March 1 2019
End Date
September 1 2020
Last Update
September 23 2019
Active Locations (1)
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1
Department of Pubblic Health and Infectious Diseases, "Sapienza" University of Rome
Rome, RM, Italy, 00100