Efficacy of Oral Supplementation of Probiotics in Children With Atopic Dermatitis

NCT04706559 | Completed

• 2 other identifiers: IRC/1886/020720/2020 MT
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Various clinical studies have evaluated the role of probiotics in children with atopic dermatitis, with some studies showing improvement in clinical outcome after supplementation of probiotics and others showing no additional benefit. This study is to provide clinical evidence of effect of a mixture of probiotics in Atopic Dermatitis (AD) patients based on improvement in SCORAD (SCORing Atopic Dermatitis) index.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• Number of participants in each sex group

  Sex distribution of Atopic Dermatitis patients in male, female or others group

  At the time of enrollment

• Duration

  Duration of Atopic Dermatitis

  At the time of enrollment

• History Of Atopy

  Personal or Family history of atopy

  Enrollment

• Change in SCORing Atopic Dermatitis (SCORAD) index

  Based on three aspects, extent of disease, disease severity and subjective symptoms combine to give a maximum possible score of 103.

  Enrollment, 4 weeks, 8 weeks, 10 weeks and 12 weeks of treatment

Secondary Outcomes (4)

• Number of participants having each of systemic illnesses

  Enrollment

• Number of participants who had taken past treatment

  Enrollment

• Age of Onset

  Enrollment

• Change in Family Dermatology Life Quality Index

  At the time of enrollment and at 8 weeks of commencing treatment.

Study Arms (2)

Group A (Interventional group)

EXPERIMENTAL

Along with below mentioned conventional treatment, the participants in group A (i.e. Interventional group) will receive conventional treatment of AD for a short duration along with probiotics for 8 weeks. One probiotic sachet twice a day will be prescribed. A sachet of 2 grams containing 1.25 billion cells per gram of 4 strains (Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii) will be used. The child will receive a total of 5 billion cells of probiotics per day.

Drug: Probiotic sachet containing mixture of four strains i.e.Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii; Drug: Conventional treatment

Group B (Conventional group)

ACTIVE COMPARATOR

All patients (i.e. in both arms) with atopic dermatitis will be prescribed emollients and cleanser as a part of routine skin care. Topical corticosteroid (i.e. Fluticasone 0.05% cream) and topical calcineurin inhibitor (tacrolimus 0.1% ointment) for sensitive areas like periorbital regions, flexures and face, will be given once daily. All patients will be given an oral antihistamine (syrup/ tablet cetirizine 0.3mg/kg) at night. It is referred to as conventional treatment.

Drug: Conventional treatment

Interventions

Probiotic sachet containing mixture of four strains i.e.Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii DRUG

Interventional group: Children with AD meeting eligibility criteria receiving probiotics and conventional treatment (topical corticosteroid, topical tacrolimus, an oral antihistamine and emollients).

Group A (Interventional group)

Conventional treatment DRUG

topical corticosteroid, topical tacrolimus, an oral antihistamine and emollients as per atopic dermatitis treatment guidelines.

Group A (Interventional group); Group B (Conventional group)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with a diagnosis of atopic dermatitis that meet Hanifin and Rajka criteria
• SCORAD ( SCORing Atopic Dermatitis) index 15- 50 at the time of enrollment

You may not qualify if:

• SCORAD (SCORing Atopic Dermatitis) index \<15 or \>50.
• Children treated with systemic corticosteroids, methotrexate, or cyclosporine in the previous 3 months and antibiotics in the previous 2 weeks.
• Immunocompromised children.
• Concomitant diagnosis of intolerance to gluten and/ or lactose.
• Pre-existing hypersensitivity to components contained in the probiotics.
• Children suffering from chronic infectious diseases.
• A child with other known systemic diseases (heart, liver or kidney diseases).
• Known case of short gut syndrome.
• Refusal of children's parents to participate in the study.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead
• Nepal Health Research Council: collaborator

Study Sites (1)

B.P. Koirala Institute of Health Sciences

Dharān, 7053, Nepal

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, there will be three investigators i.e, one principal investigator, and two co-investigators. Among them, one of the co-investigators will be blinded who will act as an assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident, Department of Dermatology and Venereology

Model Details: Assessor blinded, randomized controlled trial.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 13, 2021
• Study Start: January 3, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 15, 2021
• Last Updated: December 16, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)