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

NCT04099433 | Unknown

• 1 other identifier: 4590
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Anal Dysplasia

Keywords

HIV; HPV; Probiotics; High Resolution Anoscopy; Anal dysplasia

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the number of HPV positive anal swabs

  Clearance of anal HPV infection will be defined as: * negative swab at the end of the study in participants with positive swab at baseline * positive swab at the end of the study that shows a different genotype from baseline

  Anal swabs for HPV detection and genotyping will be performed at baseline and after the 6 months duration of the intervention

• Change from baseline in the number of dysplastic lesions

  Clearance of anal dysplasia will be defined as: \- normal histology in biopsies repeated at the end of the study on areas that showed the presence of histologically defined dysplasia at baseline.

  Areas of the anal canal that were biopsied at baseline and whom histology showed the presence of dysplasia will undergo a second biopsy after the 6 months duration of the intervention

Secondary Outcomes (4)

• Rate of adverse events

  This measure will be assessed after the 6 months duration of the intervention

• Comparison between intra-epithelial NK lymphocytes subpopulation in normal mucosa and dysplastic mucosa

  Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention

• Comparison between intra-epithelial CD4+ T lymphocytes subpopulation in normal mucosa and dysplastic mucosa

  Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention

• Comparison between intra-epithelial CD8+ T lymphocytes subpopulation in normal mucosa and dysplastic mucosa

  Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention

Study Arms (2)

Oral Bacteriotherapy Arm

EXPERIMENTAL

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

Dietary Supplement: Vivomixx

Placebo Arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vivomixx DIETARY_SUPPLEMENT

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

Oral Bacteriotherapy Arm

Placebo OTHER

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

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

Rome, RM, 00100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 40801169 DERIVED

Central Study Contacts

Gabriella d'Ettorre, Professor, MD

CONTACT

0649970801; gabriella.dettorre@uniroma1.it

Eugenio Nelson Cavallari, MD

CONTACT

eugenionelson.cavallari@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: September 23, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

IT (1)