Effect of probiotics on cutaneous fungal infection

Active, not recruiting

Conditions: Other specified local infections of the skin and subcutaneous tissue,

Registration Number: CTRI/2023/05/052182

Lead Sponsor: Dr Pratik Gahalaut

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 35

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 2.
Severe cardiac, pulmonary, gastrointestinal, renal, hepatic, or neurological disease and uncontrolled diabetes mellitus or neoplasia 3.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NO	Baseline and after 12 weeks
1. Biochemical (in serum)	Baseline and after 12 weeks
IL 6	Baseline and after 12 weeks
IL 10	Baseline and after 12 weeks
IL 12	Baseline and after 12 weeks
TNF alpha	Baseline and after 12 weeks
IFN gamma	Baseline and after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical	Objective assessment by Severity score

Trial Locations

Locations (1): SRMS Institute of Medical Sciences, Bareilly
🇮🇳
Bareilly, UTTAR PRADESH, India
SRMS Institute of Medical Sciences, Bareilly
🇮🇳Bareilly, UTTAR PRADESH, India
Dr Pratik Gahalaut
Principal investigator
9319758004
drpratikg.srmsims@gmail.com