Combined probiotic and melatonin supplementation in treatment of atopic dermatitis

The impact of combined probiotic and melatonin administration on disease severity and inflammatory markers in children with atopic dermatitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N64

Enrollment

Registered

2019-10-04

Start date

2019-09-07

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis. Atopic dermatitis, unspecified

Interventions

Intervention 1: Intervention group: Probiotic sachet (Takgen Company, Iran), containing Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus reuteri, and Lactobacillus fermentum (each 2×

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children diagnosed with atopic dermatitis Children aged 6-12 years

Exclusion criteria

Exclusion criteria: Patients who were receiving any systemic corticosteroid or other immunosuppressive drugs or taking antihistamines within the last 3 months before the study. Children diagnosed with acquired immunosuppressive disease Taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment.

Design outcomes

Primary

Measure	Time frame
SCORAD index. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: physical exmamination by pediatrician.	—

Secondary

Measure	Time frame
Objective SCORAD index. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: physical exmamination by pediatrician.;Pruritus. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Visual analogue scale 0-10.;Sleep-onset latency. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Total sleep time. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Total children's Sleep Habits. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Serum total IgE levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Radioimmunoassay.;Serum TNF-a levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa.;Serum TGF-ß levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa.	—

Measure

Time frame

Objective SCORAD index. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: physical exmamination by pediatrician.;Pruritus. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Visual analogue scale 0-10.;Sleep-onset latency. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Total sleep time. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Total children's Sleep Habits. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Children's Sleep Habits Questionnaire.;Serum total IgE levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Radioimmunoassay.;Serum TNF-a levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa.;Serum TGF-ß levels. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Sharif

Kashan University of Medical Sciences

mrsharifmd@yahoo.com+98 31 5554 0026

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026