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

Not yet recruiting

• Conditions: Not applicable

• Registration Number: CTRI/2025/06/088905
• Lead Sponsor: Cultech Ltd.

Brief Summary

This trial is expanding on thatobservation to investigate whether daily supplementation with the Lab4probiotic (as viable bacteria or inactive heat-killed bacteria) can impact uponwell-being in a cohort of middle-aged women. The trial will be a doubleblinded, 3-arm, randomized, placebo-controlled, parallel group superioritystudy consisting of 75 women (as assigned at birth), aged 40-60. Eachparticipant will provide two fecal samples, two vaginal swabs and two bloodsamples during the course of the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-30
• Last Update Posted: 2025-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 75

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Any changes in overall Quality of Life & Well Being assessed using participant completed	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.
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 Measures

Name	Time	Method
1. Any changes in the composition of the fecal and/or vaginal microbiomes.
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

Trial Locations

Locations (2)

Dhanwantari Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Sangvi Multispeciality Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Dhanwantari Hospital, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Bharat Jain

Principal investigator

9860383386

dr_bharatjain@rediffmail.com