Microbial ColonizationNCT05267119
Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab
An observational study of Microbial Colonization and Scalp--Diseases, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Scalp--Diseases
- What is being tested?
- Swab
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2019to 9 Nov 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women aged 18 years old or older who had not undergone menopause
Who may be able to join
- Healthy women
- Aged 18 years old or older who had not undergone menopause
- Consenting to the study
Who cannot join
- Scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy)
- Systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases)
- Use of topical and oral antifungal agents
- Use of cytostatic agents
- Use of topical and oral antibiotics
- Use of topical and oral vitamin D
Show all 10Show fewer
- Use of chemical products on hair (e.g. bleaching, permanent blow, hair coloring, hair straightener)
- Pregnancy
- Lactating
- Hypersensitivity towards basic ingredients of shampoo (e.g. synthetic detergent, conditioner, thickening agent).
Trial locations and contacts
1 site in 1 country.
About this study
An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.
Read the detailed description
The scalp sample of all subjects was taken to be analyzed for its microbial diversity. The samples were processed with Next-Generation Sequencer and analyzed with bioinformatics analysis.
The primary outcome was the characteristics of scalp microbiome
- Conditions
- Microbial Colonization, Scalp--Diseases
- Being tested
- Swab
- Keywords
- scalp, microbiome, hijab
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SwabProcedure or surgery
The scalp was swabbed with five strokes which were performed each in a vertical, horizontal, left diagonal, and right diagonal direction. The swab was moved back and forth for 10 times
| Study group | Role | What they receive |
|---|---|---|
| Hijab | Women wearing hijab whose scalp sample was taken for microbiome analysis Receives: Procedure: Swab | |
| No hijab | Women not wearing hijab whose scalp sample was taken for microbiome analysis Receives: Procedure: Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity and beta diversity of scalp microbiome
The alpha and beta diversity of scalp microbiome which is generated by bioinformatics analysis from the sample processed with Next-Generation Sequencing
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Oct 2019
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Sandra Widaty, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267119
- Sponsor's protocol ID
- 19-04-0438
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab
- ClinicalTrials.gov ID
- NCT05267119
- Acronym / sponsor ID
- 19-04-0438
- Conditions
- Microbial Colonization, Scalp--Diseases
- Keywords
- scalp, microbiome, hijab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 4 Mar 2022 (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.
An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.
Detailed description
The scalp sample of all subjects was taken to be analyzed for its microbial diversity. The samples were processed with Next-Generation Sequencer and analyzed with bioinformatics analysis.
The primary outcome was the characteristics of scalp microbiome
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hijab | – | Procedure: SwabWomen wearing hijab whose scalp sample was taken for microbiome analysis |
| No hijab | – | Procedure: SwabWomen not wearing hijab whose scalp sample was taken for microbiome analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women aged 18 years old or older who had not undergone menopause
Key inclusion criteria (3 listed)
- Healthy women
- Aged 18 years old or older who had not undergone menopause
- Consenting to the study
Key exclusion criteria (10 listed)
- Scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy)
- Systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases)
- Use of topical and oral antifungal agents
- Use of cytostatic agents
- Use of topical and oral antibiotics
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 |
|---|---|---|
| SwabThe scalp was swabbed with five strokes which were performed each in a vertical, horizontal, left diagonal, and right diagonal direction. The swab was moved back and forth for 10 times | Procedure or surgery | Hijab, No hijab |
Primary outcome
Alpha diversity and beta diversity of scalp microbiome
Time frame: Up to 2 years
The alpha and beta diversity of scalp microbiome which is generated by bioinformatics analysis from the sample processed with Next-Generation Sequencing
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 4 Mar 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Microbial Colonization and Scalp--Diseases, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 10 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 4 Mar 2022. 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 Indonesia. 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?
Alpha diversity and beta diversity of scalp microbiome (time frame: Up to 2 years). 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 4 Mar 2022.