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Effect of probiotics on general well-being and quality of life in women

PROGLOW- The impact of Probiotics on General well-being and Life Outcomes in Women. - PROGLOW

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088905
Enrollment
75
Registered
2025-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Multi-strain Probiotic: Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Bifidobacterium bifidum CUL-20 and Bifidobacterium animalis subsp lactis CUL-34, totaling 50

Sponsors

Cultech Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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)Timepoint: 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

MeasureTime frame
1. Any changes in the composition of the fecal and/or vaginal microbiomes. Timepoint: Day 1 and Day 112;2. Any changes in circulating bio-markers.Timepoint: Day 1 and Day 112;3. Any changes in the Rey auditory verbal learning test.Timepoint: Day 1, Day 56, Day 112—

Countries

India

Contacts

Public ContactMrs Aditi Vaidya

ProRelix Services LLP

s.thasma@prorelixresearch.com8124806366

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026