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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267119
• Other study ID #: 19-04-0438
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: November 9, 2020

Study information

• Verified date: February 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

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

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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