An interventional study of Vivomixx and Placebo in HIV and Anal Dysplasia, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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.
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:
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:
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:
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.
University of Roma La Sapienza is the lead sponsor of 397 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
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
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
Drug pages: Streptococcus thermophilus · Bifidobacterium breve · Bifidobacterium animalis subsp. lactis · Lacteol · Lactobacillus plantarum · Lacticaseibacillus paracasei · Lactobacillus helveticus
Individuals in the interventional arm will undergo daily oral intake of probiotic supplement
Individuals in the placebo arm will undergo daily oral intake of placebo supplement
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
Time frame: 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.
Time frame: 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
Rate of adverse events
The rate of adverse events occurred during the study period will be evaluated and compared between both groups
Time frame: 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 from dysplastic lesions and from normal mucosa will be taken at baseline. Biopsies will also be taken at the end of the study from previously biopsied areas, from normal mucosa and eventually from dysplastic areas that were not present at baseline. Intra-epithelial lymphocytes will be extracted from the biopsy tissue and stained to differentiate and quantify CD56+NK lymphocytes by flowcytometry. Changes from baseline will be expressed as relative difference.
Time frame: 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 from dysplastic lesions and from normal mucosa will be taken at baseline. Biopsies will also be taken at the end of the study from previously biopsied areas, from normal mucosa and eventually from dysplastic areas that were not present at baseline. Intra-epithelial lymphocytes will be extracted from the biopsy tissue and stained to differentiate and quantify CD4+ T lymphocytes by flowcytometry. Changes from baseline will be expressed as relative difference.
Time frame: 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 from dysplastic lesions and from normal mucosa will be taken at baseline. Biopsies will also be taken at the end of the study from previously biopsied areas, from normal mucosa and eventually from dysplastic areas that were not present at baseline. Intra-epithelial lymphocytes will be extracted from the biopsy tissue and stained to differentiate and quantify CD8+ T lymphocytes by flowcytometry. Changes from baseline will be expressed as relative difference.
Time frame: Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention
Started Mar 2019 (actual). Primary completion is estimated for Mar 2020, 12 months after the start.
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Studies of the drugs tested here: Streptococcus thermophilus · Bifidobacterium breve · Bifidobacterium animalis subsp. lactis · Lacteol · Lactobacillus plantarum · Lacticaseibacillus paracasei · Lactobacillus helveticus
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