Efficacy of probiotics in treating dermatophytosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 1. Biochemical (in serum)
Study Overview
Brief Summary
As per WHO dermatophytosis affects 25% of world population. There are only few anti-fungals available for treating the dermatophytosis, mainly belonging to only 2 anti-fungal families. This increases changes of cross-resistance. Further side effects of these drugs hamper effective treatment of mycoses. Probiotics are normal resident flora of gut, which can be formulated as different products. Lactic acid bacilli are commonly used as probiotics which have shown antifungal activities in vitro agaiinst dermatophytes. Hence this RCT is planned to evaluate the effect of administering probiotics as an adjuvant treatment in patients of dermatophytosis . Null hypothesis is : There will be no effect of probiotics on the various biochemical parameters in serum compared to a placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 59.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients above the age of 18 to 59 years with clinical evidence of Dermatophytosis & who are willing to take part in study with written informed consent.
Exclusion Criteria
- •Pregnant or lactating women
- •Severe cardiac, pulmonary, gastrointestinal, renal, hepatic, or neurological disease and uncontrolled diabetes mellitus or neoplasia
- •Known hypersensitivity to oral or topical antifungal agents, 4.Treatment with systemic antifungal agents in the previous one month, systemic antibiotics in the previous 2 weeks, corticosteroids or immunosuppressant in the past 6 weeks, or any investigational drug in the previous 3 months.
- •Patients with concomitant any other skin disease.
- •Patients who are not KOH positive at the baseline.
Outcomes
Primary Outcomes
1. Biochemical (in serum)
Time Frame: Baseline and after 12 weeks
IL 6
Time Frame: Baseline and after 12 weeks
IL 10
Time Frame: Baseline and after 12 weeks
IL 12
Time Frame: Baseline and after 12 weeks
TNF alpha
Time Frame: Baseline and after 12 weeks
IFN gamma
Time Frame: Baseline and after 12 weeks
NO
Time Frame: Baseline and after 12 weeks
Secondary Outcomes
- Clinical(Objective assessment by Severity score)