The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus

• Sponsor: Universiteit Antwerpen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01097356
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.

This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.

Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?

Condition or Disease	Intervention/Treatment	Phase
HPV-related Cytological Abnormalities on PAP Smear (LSIL)	Dietary Supplement: probiotic drinkers	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: common care HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear
Experimental: probiotic drinkers HPV+, LSIL patients who will drink the study drink for 6 months	Dietary Supplement: probiotic drinkers; HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months

Outcome Measures

Primary Outcome Measures

1. 1.proportion of HPV positives in both arms [6months]

2. 2. proportion of regression of LSIL lesion in both arms [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• women with a new LSIL diagnosis an HPV positivity on PAP smear

Exclusion Criteria:

• women over 65

• immunocompromised patients (because of disease or drugs)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veronique Verhoeven	Wilrijk		Belgium	2610

Sponsors and Collaborators

• Universiteit Antwerpen

Investigators

• Principal Investigator: veronique verhoeven, MD, PhD, Universiteit Antwerpen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Veronique Verhoeven, professor, Universiteit Antwerpen
• ClinicalTrials.gov Identifier: NCT01097356
• Other Study ID Numbers: 2414VV
• First Posted: Apr 1, 2010
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Oct 1, 2021