| CTRI Number |
CTRI/2025/06/088905 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of probiotics on general well-being and quality of life in women |
|
Scientific Title of Study
|
PROGLOW- The impact of Probiotics on General well-being and Life Outcomes in Women. |
| Trial Acronym |
PROGLOW |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL-PB-CT01-24 version 1.0 31 MAR 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketan Kshirsagar |
| Designation |
Principal Investigator |
| Affiliation |
Sangvi Multispeciality Hospital Pvt. Ltd. |
| Address |
City Survey No 2387, Survey No 71,1,2,189, Shirode Road, near Krushna chowk, Krushna Nagar, New Sangvi, Pimpri-Chinchwad.
Pune
MAHARASHTRA
411027
India |
| Phone |
9049002749 |
| Fax |
|
| Email |
ketankshirsagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sornaraja Thasma |
| Designation |
Director, Quality and Business |
| Affiliation |
ProRelix Services LLP |
| Address |
102 A B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune.
Pune
MAHARASHTRA
411052
India |
| Phone |
8124806366 |
| Fax |
|
| Email |
s.thasma@prorelixresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Aditi Vaidya |
| Designation |
Senior Manager, CR Operations |
| Affiliation |
ProRelix Services LLP |
| Address |
102 A B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune.
Pune
MAHARASHTRA
411052
India |
| Phone |
8602571013 |
| Fax |
|
| Email |
a.vaidya@prorelixresearch.com |
|
|
Source of Monetary or Material Support
|
| Cultech Ltd. Unit 2 Christchurch Road, Baglan Industrial Estate, Port Talbot, Wales, UK, SA12 7BZ |
|
|
Primary Sponsor
|
| Name |
Cultech Ltd. |
| Address |
Unit 2 Christchurch Road, Baglan Industrial Estate, Port Talbot, Wales, UK, SA12 7BZ |
| Type of Sponsor |
Other [Nutritional Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bharat Jain |
Dhanwantari Hospital, Pune |
Clinical Research Department, second floor, 339-c, Rasta Peth, Pune, Maharashtra 411002
Pune
MAHARASHTRA |
9860383386
dr_bharatjain@rediffmail.com |
| Dr Seema Agrawal |
Patel Clinic and Research Centre |
Door No. 13,14,15 number 478,Ground floor, Mittal court, Rasta peth, Pune 411 011, Maharashtra, India
Pune
MAHARASHTRA |
09822300449
drseemaagrawal01@gmail.com |
| Dr Ketan Kshirsgar |
Sangvi Multispeciality Hospital, Pune |
Clinical Research Department, 5th floor, Research room 2, City Survey No 2387, Survey No 71/1/2/189, Shirode Rd, near Krushna chowk, Krushna nagar, New Sangvi, Pimpri-Chinchwad, Pune- 411027, MAHARASHTRA
Pune
MAHARASHTRA |
9049002749
ketankshirsagar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
| Jivanrekha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi-strain postbiotic |
Replica of Multi-strain probiotic but containing non-viable (heat-killed) bacteria. One capsule per day for 112 days. |
| Intervention |
Multi-strain probiotic |
Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Bifidobacterium bifidum CUL-20 and Bifidobacterium animalis subsp lactis CUL-34, totaling 50 billion viable bacteria per day. One capsule per day for 112 days. |
| Comparator Agent |
Placebo |
Matching both probiotic and post-biotic but containing excipients only. One capsule per day for 112 days. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Females (assigned at birth) aged 40 to 60
2. Willing to provide fecal samples, blood samples and vaginal swabs
3. BMI of less than 25 kg/m2
4. Willing to maintain normal diet and lifestyle during the study
5. Willing to refrain from taking other probiotic supplements during the study
|
|
| ExclusionCriteria |
| Details |
1. Consumption of oral antibiotics within the last 3 months
2. Regular consumption of probiotics within the last 1 month prior to the study
3. Premature menopause (onset before age of 40),
4. Undergone hysterectomy or ovariectomy
5. Given birth in the last 3 months, currently pregnant or planning pregnancy
6. Receiving hormone replacement therapy
7. Shift worker
8. Immunodeficient or undergoing immunosuppressive therapy
9. Diagnosed with diabetes/cardiovascular disease/cancer/dementia
10. Unexplained loss of weight in recent months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Any changes in overall Quality of Life & Well Being assessed using participant completed
questionnaires (Weekly well-being diary, Athens insomnia scale and Hospital anxiety and depression scales) |
Day 1, Day 56, Day 112 for questionnaires (Athens insomnia scale and Hospital anxiety and depression scales). Once every week from Day 1 to Day 112 for Weekly well-being diary. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Any changes in the composition of the fecal and/or vaginal microbiomes.
|
Day 1 and Day 112 |
| 2. Any changes in circulating bio-markers. |
Day 1 and Day 112 |
| 3. Any changes in the Rey auditory verbal learning test. |
Day 1, Day 56, Day 112 |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
30/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This trial is expanding on that
observation to investigate whether daily supplementation with the Lab4
probiotic (as viable bacteria or inactive heat-killed bacteria) can impact upon
well-being in a cohort of middle-aged women. The trial will be a double
blinded, 3-arm, randomized, placebo-controlled, parallel group superiority
study consisting of 75 women (as assigned at birth), aged 40-60. Each
participant will provide two fecal samples, two vaginal swabs and two blood
samples during the course of the trial. |