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CTRI Number  CTRI/2025/09/095497 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   PRO-HAIR Study 
Scientific Title of Study   Efficacy of Probiotics as an Adjunct to Standard Therapy in Androgenetic Alopecia(HAIR loss) : RCT (PRO- HAIR study ) 
Trial Acronym  PRO-HAIR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Palreddy Akshara 
Designation  SR (Academic) 
Affiliation  AIIMS, Delhi 
Address  Room No 18, Ground Floor , Department of Plastic, Reconstructive and burns surgery, Burns and Plastic Surgery Block, Near JPNATC,AIIMS Delhi

South
DELHI
110029
India 
Phone  7982759086  
Fax    
Email  aksharapalreddy001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maneesh Singhal 
Designation  Professor 
Affiliation  AIIMS,Delhi 
Address  HOD Office, 2nd Floor , Department of Plastic, Reconstructive and burns surgery, Burns and Plastic Surgery Block AIIMS Delhi

South
DELHI
110029
India 
Phone  9810373345  
Fax    
Email  drmaneesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maneesh Singhal 
Designation  Professor 
Affiliation  AIIMS,Delhi 
Address  HOD Office, 2nd Floor , Department of Plastic, Reconstructive and burns surgery, Burns and Plastic Surgery Block AIIMS Delhi

South
DELHI
110029
India 
Phone  9810373345  
Fax    
Email  drmaneesh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Delhi Thesis grant 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Delhi Thesis grant 
Address  All India Institute Of Medical Sciences Delhi Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 Akshara Palreddy  AIIMS delhi  Room No 18, Ground Floor , Department of Plastic, Reconstructive and burns surgery, Burns and Plastic Surgery Block, Near JPNATC,AIIMS Delhi
South
DELHI 
7982759086

aksharapalreddy001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Probiotics + Standard treatment (Hair transplant/medications  Will receive the same standard therapy as comparator group, along with a daily oral probiotic capsule for 16 weeks. The probiotic will contain: o Lactiplantibacillus Bifidobacterium longum (60 × 10^9 CFU).  
Comparator Agent  Standard treatment  Will receive standard therapy for androgenetic alopecia including: o Topical minoxidil 5% solution applied twice daily. o Oral finasteride 1 milligram once daily. o Platelet-rich plasma injections administered monthly for 4 sessions. o Growth factor concentrate injections administered monthly for 4 sessions. o Hair transplant if clinically indicated  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Adults aged 18 to 50 years with clinically diagnosed AGA (Hamilton–Norwood scale for men, Ludwig scale for women).
No antibiotic or probiotic use in the past month.
Willingness to provide stool samples and adhere to study protocols.


 
 
ExclusionCriteria 
Details  Presence of other forms of alopecia (e.g., alopecia areata).
Gastrointestinal disorders or systemic inflammatory conditions.
Immunocompromised status or use of immunosuppressive medications.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in hair density measured objectively via standardized trichoscopic imaging and quantified using validated software-based analysis.
 
0,4 weeks,8 weeks,12 weeks and 16 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient-reported outcomes on hair satisfaction and quality of life using Validated Questionnaire
Assessment of gut microbiota composition through 16S rRNA sequencing of stool samples before the start of treatment and at 16 weeks after initiation of probiotic treatment. Bacterial 16S rRNA gene sequences (V3–V4 regions) will be amplified from the whole genome using the primers, 341F and 805R and amplicon libraries will be sequenced on an Illumina NovaSeq platform.


Evaluation of systemic inflammatory markers and hormonal profiles
 
0, 16 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   13/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Androgenetic alopecia, also known as male or female pattern hair loss, is the most common type of hair loss, affecting up to 80% of men and 50% of women by the age of 70. It is caused by a combination of genetics and hormones, especially a form of testosterone called dihydrotestosterone. Current treatments such as topical minoxidil, oral finasteride, platelet-rich plasma injections, and growth factor therapies mainly work at the scalp level but may not address deeper body-wide issues.

Recent research has shown that gut health may play a role in hair growth. An imbalance in gut bacteria—called dysbiosis—has been linked to several skin and hair problems. Probiotics, which are beneficial bacteria, may help improve hair condition by restoring gut balance, reducing inflammation, and improving nutrient absorption.

This study will explore whether taking probiotics alongside standard hair loss treatments can improve hair growth and patient satisfaction. It will also examine changes in gut bacteria before and after treatment, to see if any patterns are linked with better outcomes.

This study may significantly impact the management paradigm of androgenetic alopecia by validating the clinical utility of probiotics as a systemic adjunct. 

By profiling gut microbiota and correlating it with hair parameters and treatment responses, the study also contributes to the growing field of personalized medicine. Identifying microbial biomarkers for prognosis or therapeutic success could open doors to precision-targeted interventions in AGA and related conditions.




 
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