| 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
|
|
|
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
|
|
|
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.
|