Helicobacter Pylori InfectionNCT03411733
Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris
An observational study of Helicobacter Pylori Infection and Acne Vulgaris, run by Sohag University at 1 site in Egypt.
Trial summary
The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Acne Vulgaris
- What is being tested?
- Blood and stool samples collection
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag University hospital. Healthy volunteers.
Who may be able to join
- Acne vulgaris patients
- Healthy volunteers (control)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology outpatient clinic, Sohag University Hospital
Sohag, 82524
About this study
Official title: 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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection, Acne Vulgaris
- Being tested
- Blood and stool samples collection
- Keywords
- acne vlugaris, prevalence, Helicobacter Pylori
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and stool samples collectionOther
Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection
| Study group | Role | What they receive |
|---|---|---|
| acne vlugaris group | Included recruited patients with acne vulgaris Intervention: Blood and stool samples collection Receives: Other: Blood and stool samples collection | |
| Control group | Included healthy participants Intervention: Blood and stool samples collection Receives: Other: Blood and stool samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
H.pylori infection
Prevalence of H.pylori infection among acne group and control group
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Mar 2017
- Primary completion1 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ali, Sohag University
- Investigators
- Ramadan Saleh, MD, Study director, Sohag Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411733
- Sponsor's protocol ID
- HPAV001
- Status last verified
- Apr 2018
- First submitted
- 20 Jan 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All available data shall be shared with other researchers upon their request after agreement of study director
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03411733
- Acronym / sponsor ID
- HPAV001
- Conditions
- Helicobacter Pylori Infection, Acne Vulgaris
- Keywords
- acne vlugaris, prevalence, Helicobacter Pylori
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acne vlugaris group | – | Other: Blood and stool samples collectionIncluded recruited patients with acne vulgaris Intervention: Blood and stool samples collection |
| Control group | – | Other: Blood and stool samples collectionIncluded healthy participants Intervention: Blood and stool samples collection |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag University hospital. Healthy volunteers.
Key inclusion criteria (2 listed)
- Acne vulgaris patients
- Healthy volunteers (control)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and stool samples collectionCollection of blood and stool samples from each participants for H.pylori antigen/ antibody detection | Other | Control group, acne vlugaris group |
Primary outcome
H.pylori infection
Time frame: one year
Prevalence of H.pylori infection among acne group and control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Undecided. All available data shall be shared with other researchers upon their request after agreement of study director
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramadan Saleh, MD study director
Sohag Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Acne Vulgaris, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H.pylori infection (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.