Application of Oral Bacteriotherapy to Promote Anal HPV Clearance in HIV Positive Individuals

NCT ID: NCT04099433

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-09-01

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, placebo controlled study, investigators will evaluate the ability of oral bacterio-therapy to enhance the clearance of anal HPV infection and anal HPV related dysplasia in HIV infected subjects.

Participants will be evaluated for anal HPV infection and anal dysplasia before and after a 6 months course of daily investigational product intake (Viviomixx® or placebo). HPV infection rate and presence of dysplasia at baseline and at the end of the study will be compared.

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 are grater than those observed for other common neoplasms in the same HIV negative sub-populations. Nowadays, screening for anal precancerous dysplasia has been included in most national and international HIV management guidelines; in particular, italian guidelines suggest to screen for the presence of HPV related dysplasia:

• HIV+ MSM
• All individuals with previous or current evidence of ant-genital condyloma
• Women with cytology abnormalities on cervical Pap-smear Since no direct anti-HPV drug is currently available and control or clearance of the infection is possible only trough the effect of immune response, interest is addressed to find strategies to promote spontaneous clearance of infection.

In published studies, oral bacterio-therapy demonstrated the ability to promote HPV clearance and HPV related dysplasia regression in HIV negative women.

In the present randomized, double blind, placebo controlled trial, 40 HIV infected individuals with HPV related anal dysplasia will be enrolled.

At baseline participants will undergo:

• anal HPV research and identification
• anal cytology
• anal brushing for evaluation of local inflammatory milieu and microbiota

Subjects with identified HPV anal infection and anal dysplasia will undergo High Resolution Anoscopy (HRA).

During HRA, extra biopsies of identified abnormal areas and biopsies of normal mucosa will be obtained. Extra biopsies will be used to investigate the distribution of intra-epithelial immune cells populations.

Participants will then undergo 6 months of oral supplementation with probiotics (Vivomixx®) or placebo.

At the end of the supplementation period (Vivomixx or placebo), participants will undergo:

• anal HPV research and identification
• anal cytology
• anal brushing for evaluation of local inflammatory milieu and microbiota
• HRA

During HRA, extra biopsies of identified abnormal areas and biopsies of normal mucosa will be obtained. Extra biopsies will be used to investigate the distribution of intra-epithelial immune cells populations.

Conditions

HIV; Anal Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Bacteriotherapy Arm

Individuals in this study arm will undergo 6 months of daily intake of an oral probiotic formulation (Vivomixx: 4 sachets/day, each sachet containing 450 billion live bacteria). Probiotic sachets are indistinguishable from placebo

Group Type: EXPERIMENTAL

Vivomixx

Intervention Type: DIETARY_SUPPLEMENT

Individuals in the interventional arm will undergo daily oral intake of probiotic supplement

Placebo Arm

Individuals in this study arm will undergo 6 months of daily intake of placebo (4 sachets/day). Placebo sachets are indistinguishable from probiotic

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Individuals in the placebo arm will undergo daily oral intake of placebo supplement

Interventions

Vivomixx

Individuals in the interventional arm will undergo daily oral intake of probiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Individuals in the placebo arm will undergo daily oral intake of placebo supplement

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Prof. Gabriella d'Ettorre

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pubblic Health and Infectious Diseases, "Sapienza" University of Rome

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gabriella d'Ettorre, Professor, MD

Role: CONTACT

gabriella.dettorre@uniroma1.it

0649970801

Eugenio Nelson Cavallari, MD

Role: CONTACT

eugenionelson.cavallari@uniroma1.it

Facility Contacts

Gabriella d'Ettorre, Professor

Role: primary

gabriella.dettorre@uniroma1.it

Eugenio Nelson Cavallari, MD

Role: backup

eugenionelson.cavallari@uniroma1.it

References

Pedersen TB, Pachler FR, Rosenberg J, Andresen K. Interventions for anal canal intraepithelial neoplasia. Cochrane Database Syst Rev. 2025 Aug 13;8(8):CD009244. doi: 10.1002/14651858.CD009244.pub3.

Reference Type: DERIVED

PMID: 40801169 (View on PubMed)

Other Identifiers

4590

Identifier Type: -

Identifier Source: org_study_id