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CTRI Number  CTRI/2024/08/072591 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluate The Effectiveness And Safety Of VHAKM Akkermansia Muciniphila In Women With UTI 
Scientific Title of Study   A Randomized Double-Blind, Placebo-Controlled, Parallel Multicenter Phase III Study To Evaluate The Effectiveness And Safety Of VHAKM Akkermansia Muciniphila On The Clinical And Biological Parameters Of Women With Urinary Tract Infection 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BLEN-001-24, Version : 01, Date: 04 May 24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Radha Parthasarathy 
Designation  Principal Investigator 
Affiliation  Srinivasan Rajalakshmi Memorial Hospital (SRMH) 
Address  Room No.101, General Medicine Department, Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai.

Chennai
TAMIL NADU
600061
India 
Phone  9840117136  
Fax    
Email  radhaparthasarathy171@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radha Parthasarathy 
Designation  Principal Investigator 
Affiliation  Srinivasan Rajalakshmi Memorial Hospital (SRMH) 
Address  Room No.101, General Medicine Department,Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai.

Chennai
TAMIL NADU
600061
India 
Phone  9840117136  
Fax    
Email  radhaparthasarathy171@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radha Parthasarathy 
Designation  Principal Investigator 
Affiliation  Srinivasan Rajalakshmi Memorial Hospital (SRMH) 
Address  Room No.101, General Medicine Department,Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai.

Chennai
TAMIL NADU
600061
India 
Phone  9840117136  
Fax    
Email  radhaparthasarathy171@gmail.com  
 
Source of Monetary or Material Support  
Vidya Herbs Pvt Ltd, Vidya Building, N3-3, 24th Main Rd, 1st Phase, J. P. Nagar, Bengaluru, Karnataka 560078, India 
 
Primary Sponsor  
Name  Vidya Herbs Pvt LTD 
Address  Vidya Building N3-3, 24th Main, JP Nagar 1st Phase, Bangalore - 560078 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Radha Parthasarathy  Srinivasan Rajalakshmi Memorial Hospital (SRMH)  Room No.101, General Medicine Department, 7/1, Voltas Colony, Nanganalur, Chennai-600061, Tamil Nadu, India.
Chennai
TAMIL NADU 		 9840117136

radhaparthasarathy171@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Chennai Ethical Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Dose: Take one capsules or as directed, best taken prior to a meal. Frequency: One Capsule or as directed Route of Administration: Oral Total Duration of such Intervention:56 days 
Intervention  Probiotic VHAKM-Akkermansia Muciniphila  Dose: Take one capsules or as directed, best taken prior to a meal. Frequency: One Capsule or as directed Route of Administration: Oral Total Duration of such Intervention:56 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Post-menopausal women are defined as greater than 12 months since their last menstrual period. Menopause may be natural or induced due to surgical or medical intervention.
2. Have a history of recurrent UTIs, defined as greater or equal to 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit, at the discretion of the investigator. At least one episode must be diagnosed medically and treated by a health care professional, the remaining two may be self-reported.
3. Voluntarily participating in the clinical study, fully understanding, and being fully informed of the study, and having signed the Informed Consent Form.
4. Willingness and capability to complete all the study procedures. 
 
ExclusionCriteria 
Details  1. Immunosuppressants
2. Known allergies to investigational product or its excipients.
3. Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at the time of screening.
4. Women who have needed changes to medical intervention or in-office procedures in the last 3 months.
5. Women who wear a pessary.
6. Women who use catheters regularly.
7. Women with an obstruction or neurogenic bladder causing incomplete bladder emptying. Individuals who have taken oral antibiotics (or topical antibiotics in their urogenital area) within
the previous 30 days.
8. Individuals that have a significant acute or chronic co-existing illness such as renal diseases (renal failure, nephrolithiasis), anatomical urinary tract abnormalities, intestinal disease,severe uncontrolled metabolic or cardiovascular disease (such as diabetes or hypertension), anticoagulant therapy, cancer.
9. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
• Incidence rate of symptomatic UTI  •Baseline (Day 01)
•Visit 05(Day 60): End of Study 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in the vaginal pH from baseline to Day 60 (end of study)
• The mean number of UTIs experienced per from baseline to Day 60 (end of study)
• Change in the FSH from baseline to Day 60 (end of study)
• Change in the LH from baseline to Day 60 (end of study)
• Change in the Serum estradiol levels from baseline to Day 60 (end of study)
• Change in the Serum testosterone levels from baseline to Day 60 (end of study)
• Change in the antral follicle count from baseline to Day 60 (end of study)
• Change in the ovarian volume from baseline to Day 60 (end of study)
 		 •Baseline (Day 01)
•Visit 05(Day 60): End of Study 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Study Title- A Randomized double-blind, placebo-controlled, parallel multicentre phase III study to evaluate the effectiveness and safety of VHAKM- Akkermansia muciniphila on the clinical and biological parameters of women with urinary tract infection.

Study Population- 60 Patients with Irritable Bowel Syndrome

Study Duration- 2 Months

Study Design- A randomized double-blind, placebo-controlled, parallel,multi-center, phase 3 clinical trial.

Inclusion Criteria-

1. Women aged between 18 and 70.

2. Post-menopausal women are defined as greater than 12 months since their last menstrual period Menopause may be natural or induced due to surgical or medical intervention.

3. Have a history of recurrent UTIs, defined as greater than or equal 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit at the discretion of the investigator. At least one episode must be diagnosed medically and treated by a health care professional, the remaining two may be self-reported.

4. Voluntarily participating in the clinical study, fully understanding, and being fully informed of the study, and having signed the Informed Consent Form (ICF).

5. Willingness and capability to complete all the study procedures.

Exclusion Criteria –

1. Immunosuppressants

2. Known allergies to investigational product or its excipients.

3. Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at the time of screening.

4. Women who have needed changes to medical intervention or in-office procedures in the last 3 months.

5. Women who wear a pessary.

6. Women who use catheters regularly.

7. Women with an obstruction or neurogenic bladder causing incomplete bladder emptying. Individuals who have taken oral antibiotics (or topical antibiotics in their urogenital area) within the previous 30 days.

8. Individuals that have a significant acute or chronic co-existing illness such as renal diseases (renal failure, nephrolithiasis), anatomical urinary tract abnormalities, intestinal disease, severe uncontrolled metabolic or cardiovascular disease (such as diabetes or hypertension), anticoagulant therapy, cancer.

9. Medical conditions or diseases that may affect subject safety or confound study results in the investigator’s opinion.

Dose & Mode of Administration-

Take one capsule or as directed, best taken prior to a meal. Frequency: One Capsule or as directed Route of Administration: Oral

Primary Outcome Measure-

• Incidence rate of symptomatic UTI

Secondary Outcome Measures-

ʉۢ Change in the vaginal pH from baseline to Day 60 (end of study)

• The mean number of UTIs experienced per from baseline to Day 60 (end of study)

• Change in the FSH from baseline to Day 60 (end of study)

• Change in the LH from baseline to Day 60 (end of study)

• Change in the Serum estradiol levels from baseline to Day 60 (end of study)

• Change in the Serum testosterone levels from baseline to Day 60 (end of study)

• Change in the antral follicle count from baseline to Day 60 (end of study)

• Change in the ovarian volume from baseline to Day 60 (end of study)

Clinical evaluation- 

  • Haematological and hepatic biomarkers were analyzed following the standard medical test protocols at screening (baseline) and end of treatment (Day 60)
  • Vital signs measurement and physical examination will be carried out at Screening, day 1, day 14, day 28, day 45 and day 60.

Evaluation Schedule-

Visit 01(Day 01) Baseline-

• Informed consent

• Demographic data

• Medical and surgical history

• Medication history

• Physical examination

• Vital signs

• Checking of eligibility criteria (Inclusion/exclusion criteria)

• Randomization

• Dispensing of study medication

• Vaginal pH

• Fasting Blood sugar level

• Subject treatment and diary filling instruction

• Providing patient diary

Visit 05 (Day 60 ± 3 days) End of Treatment Visit

• Vital signs

• Physical examination

• Collection of patient diary and checking treatment compliance

• Fasting Blood sugar level

• Vaginal Ph

• All adverse events will be reported throughout the study duration

Safety Endpoints-

• Number of participants who experienced at least one Adverse Event during the study duration.

• Number of participants who discontinued study drug due to an Adverse Event during the study

Ethical Considerations-

The study will be conducted as per the National Ethical Guidelines for Biomedical and Health Research involving Human participants ICMR (2017), ICH (Step 5) ’Guidance on Good Clinical Practice’, New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) dated 19 Mar 2019, ’Good Laboratory Practice’, ‘Good Clinical Practices for Clinical Research in India’ Guidelines, Good Clinical Laboratory Practice (GCLP) and Declaration of Helsinki (Fortaleza, October 2013).

 
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