The Effect of Probiotics on the Clearance of the Human Pa... | NCT01097356

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

NCT01097356

Sponsor

Universiteit Antwerpen

Status

Completed

Last Update Posted

Oct 1, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Interventions

probiotic drinkers

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Mar 31, 2010

First Posted Date

Apr 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2021

Last Update Posted Date

Oct 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
common care	No Intervention	HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear
probiotic drinkers	Experimental	HPV+, LSIL patients who will drink the study drink for 6 months	Dietary Supplement: probiotic drinkers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotic drinkers	Dietary Supplement	HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months	probiotic drinkers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1.proportion of HPV positives in both arms		6months
2. proportion of regression of LSIL lesion in both arms		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
veronique verhoeven, MD, PhD	Universiteit Antwerpen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Veronique Verhoeven		Wilrijk		2610	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D000081483	Squamous Intraepithelial Lesions

Ancestor Terms

ID	Term
D065308	Morphological and Microscopic Findings
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided