Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab

An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.

Study Overview

• Status: Completed
• Conditions: Microbial Colonization; Scalp--Diseases
• Intervention / Treatment: Procedure: Swab

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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy women aged 18 years old or older who had not undergone menopause

Description

Inclusion Criteria:

• Healthy women
• Aged 18 years old or older who had not undergone menopause
• Consenting to the study

Exclusion Criteria:

• 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
• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hijab; Women wearing hijab whose scalp sample was taken for microbiome analysis	Procedure: Swab; 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
No hijab; Women not wearing hijab whose scalp sample was taken for microbiome analysis	Procedure: Swab; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 2 years

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): November 9, 2020

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: microbiome; scalp; hijab
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 19-04-0438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No