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CTRI Number  CTRI/2023/05/052182 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 10/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of probiotics on cutaneous fungal infection 
Scientific Title of Study   Efficacy of probiotics in treating dermatophytosis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratik Gahalaut 
Designation  Professor and Head (Dermatology) 
Affiliation  SRMS Institute of Medical Sciences, Bareilly 
Address  Department of Dermatology SRMS Institute of Medical Sciences, Nainital Road, Bareilly

Bareilly
UTTAR PRADESH
243202
India 
Phone  9319758004  
Fax    
Email  drpratikg.srmsims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pratik Gahalaut 
Designation  Professor and Head (Dermatology) 
Affiliation  SRMS Institute of Medical Sciences, Bareilly 
Address  Department of Dermatology SRMS Institute of Medical Sciences, Nainital Road, Bareilly

Bareilly
UTTAR PRADESH
243202
India 
Phone  9319758004  
Fax    
Email  drpratikg.srmsims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vishavjot 
Designation  Senior Resident 
Affiliation  SRMS Institute of Medical Sciences, Bareilly 
Address  Department of Dermatology, SRMS Institute of MEdical Sciences, Bareilly

Bareilly
UTTAR PRADESH
243202
India 
Phone  8769472888  
Fax    
Email  dermavishu@gmail.com  
 
Source of Monetary or Material Support  
SRMS Institute of Medical Sciences, Bareilly 
 
Primary Sponsor  
Name  Dr Pratik Gahalaut 
Address  Department of Dermatology SRMSIIMS, Bareilly 243202 
Type of Sponsor  Other [principal investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratik Gahalaut  SRMS Institute of Medical Sciences, Bareilly  Department of Dermatology, SRMSIMS, Nainiital Road, Bareilly
Bareilly
UTTAR PRADESH 		 9319758004

drpratikg.srmsims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, SRMSIMS, Bareilly  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  placebo capsules  Each placebo capsule contains excipient ( potato starch). 1 capsule daily orally for 8 weeks in total 
Intervention  probiotic  These will be given as capsular preparations. Each  capsule contains- 5 Billion CFU Lactobacillus johnsonii UBLJ-01-3.8 billion cfu Bifidobacterium breve UBBr-01-0.6 billion cfu Lactobacillus fermentum UBLF-31- 0.3 billion cfu Lactobacillus reuteri UBLRu-87-0.3 billion cfu Vitamin D3 (cholecalciferol) - 400 IU  Vitamin E (d-alpha tocopherol) - 4 mg/6 IU  Fructo oligosaccharides- 100 mg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  1. 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.
5. Patients with concomitant any other skin disease.
6. Patients who are not KOH positive at the baseline. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Biochemical (in serum)
IL 6
IL 10
IL 12
TNF alpha
IFN gamma
NO 		 Baseline and after 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical
Objective assessment by Severity score
Subjective VAS scoring by patient 		 Baseline and after 12 weeks 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpratikg.srmsims@gmail.com].

  6. For how long will this data be available start date provided 15-10-2024 and end date provided 15-10-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
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. 
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