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Understanding the effect of probiotics consumption in improving the Atopic Dermatitis disease

A randomized double-blind placebo controlled trial to compare the safety and efficacy of probiotic formulation in Indian patients with Atopic Dermatitis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068558
Enrollment
60
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: L208- Other atopic dermatitis

Interventions

Intervention1: Probiotic formulation: Each 1 gram sachet (given once daily) contains: â?¢ Probiotic Blend - 5 Billion CFU containing Lactobacillus johnsonii UBLJ-01-3.8 billion cfu

Sponsors

Unique Biotech Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with age of two to eighteen years diagnosed with atopic dermatitis (mild to moderate (SCORAD of 50).

Exclusion criteria

Exclusion criteria: 1) Patient with associated (inflammatory and infectious) skin diseases 2) Patients using oral corticosteroids or monoclonal antibodies or immunosuppressants within 30 days before enrolment. 3) Use of phototherapy for AD in the previous 2 months. 4) Probiotic intake in the previous 2 months. 5) Systemic antibiotic treatment in the previous 4 days; fever 6) Patients in whom any of the study products is contraindicated. 7) Patients who have participated in research studies with medicinal products during the previous 3 months. 8) patients with gluten or lactose intolerance or inflammatory bowel disease (Crohn disease or ulcerative colitis)

Design outcomes

Primary

MeasureTime frame
A clinical tool used to assess the extent and severity of disease i.e. SCORAD (SCORing Atopic Dermatitis) Index of 0 after six monthsTimepoint: 6 months

Secondary

MeasureTime frame
Serum cytokines such as IL17 ( 17a, 17c), IL-4, IL-6,IL-10, IL-13, IFN-gamma & TNF-alpha (Reduced serum concentration of inflammatory cytokines) Serum IgE levels & Absolute eosinophil count (AEC) will be assessed.Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Manoj Kumar Tembhre

All India Institute of Medical Sciences (AIIMS), New Delhi

manojkt143@gmail.com8800502994

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026