Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris

April 30, 2018 updated by: Dina Ali, Sohag University

Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris

The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study included patients with acne vulgaris and healthy control participants. The study recruited both sexes, all grades of acne, adolescents and young adults.

All patients were subjected to complete history, general and skin examination Acne vlugaris Patients were classified into mild, moderate and severe according to the classification of American Academy of dermatology for acne vulgaris.

Detection of H. pylori infection:

Blood and stool samples were taken from each participant and was directly transferred to laboratory for detection of H. Pylori antigen and antibody.

An enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG antibodies against H.Pylori in human serum.

A monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori specific antigen in stool samples.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Dermatology outpatient clinic, Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag University hospital.

Healthy volunteers.

Description

Inclusion Criteria:

  • Acne vulgaris patients
  • Healthy volunteers (control)

Exclusion Criteria:

  • Patients with a history of drug intake that affects H. Pylori such as proton-pump inhibitors, clarithromycin, tetracyclines, amoxicillin or metronidazole within previous two weeks were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acne vlugaris group
Included recruited patients with acne vulgaris Intervention: Blood and stool samples collection
Other: Blood and stool samples collection
Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection
Control group
Included healthy participants Intervention: Blood and stool samples collection
Other: Blood and stool samples collection
Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H.pylori infection
Time Frame: one year
Prevalence of H.pylori infection among acne group and control group
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Ramadan Saleh, MD, Sohag Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

January 20, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPAV001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All available data shall be shared with other researchers upon their request after agreement of study director

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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