The Impact of Probiotics on Well-being in Women

NCT06507111 | Completed

• 1 other identifier: ProWOME
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

An exploratory study to determine whether daily supplementation with a probiotic product impacts the overall well-being of women aged between 45 - 65

Conditions

Female; Healthy Aging

Keywords

Well-being; Probiotic

Outcome Measures

Primary Outcomes (3)

• Quality of Life Questionnaire

  Quality of life questionnaire to evaluate the participants quality of life post probiotic supplementation. This QoL questionnaire uses a non-numeric, 5-point scale, ranking the presence and severity of symptoms as "none, mild, moderate, severe, and extremely severe".

  At Day 1, Day 56 and Day 112 ± 3 after trial start

• Sleep Quality Questionnaire

  Sleep quality questionnaire to measure the participants quality of sleep post probiotic supplementation. This sleep questionnaire uses the Athens Insomnia Scale and reports sleep quality using select phrases, and not a scored scale, such as "no problem, minor problem, considerable problems, serious problems". These phrases are question dependent.

  At Day 1, Day 56 and Day 112 ± 3 after trial start

• Mood Questionnaire

  Mood questionnaires to evaluate the participants mood post probiotic supplementation. This mood questionnaire is based off the Hospital Anxiety Depression Scale (HADS) and uses a four point scale for severity ranging from "0 - 3" with 0 being the lowest symptom severity and 3 being the highest symptom severity.

  At Day 1, Day 56 and Day 112 ± 3 after trial start

Secondary Outcomes (5)

• Weekly Well-being Diary

  Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105 and 112

• Bacterial composition of faecal samples via sequencing

  At Day 1 and Day 112 ± 3 after trial start

• Bacterial composition of vaginal samples via sequencing

  At Day 1 and Day 112 ± 3 after trial start

• Blood plasma analysis for plasma lipids

  At Day 1 and Day 112 ± 3 after trial start

• Blood plasma analysis inflammatory markers

  At Day 1 and Day 112 ± 3 after trial start

Study Arms (2)

Active

ACTIVE COMPARATOR

Lab4P Multi-strain Probiotic (comprising Lactobacilli and bifidobacteria species) with Vitamin C, Vitamin D and Zinc

Dietary Supplement: Lab4P

Placebo

PLACEBO COMPARATOR

Matching placebo

Other: Placebo

Interventions

Lab4P DIETARY_SUPPLEMENT

Lactobacillus acidophilus CUL-60, Lactobacillus acidophilus CUL-21, Lactobacillus plantarum CUL-66, Bifidobacterium bifidum CUL-20 and Bifidobacterium animalis subsp. lactis CUL-34 at a dose of 50 billion bacteria per/ day combined with vitamin C (80 mg/day), Vitamin D (400 IU/day) and Zinc (10 mg/day) on a microcrystaline cellulose (MCC) base Daily dose: 50 billion bacteria per day

Active

Placebo OTHER

MCC alone

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 45 to 65
• Willing to provide faecal samples, blood samples and vaginal swabs
• BMI of less than 30 kg/m2
• Willing to maintain normal diet and lifestyle during the study
• Willing to refrain from taking other probiotic supplements during the study
• Normal (or corrected-to-normal) vision without colour blindness in order to complete the cognitive task

You may not qualify if:

• No oral antibiotics within the last 3 months
• No previous been involvement in a Cultech funded study
• No regular consumption of probiotics within the last 1 month prior to the study
• Premature menopause (onset before age of 40)
• Given birth in the last 3 months, currently pregnant or planning pregnancy
• Receiving hormone replacement therapy
• Shift worker
• Diagnosed with diabetes
• Immunodeficient or undergoing immunosuppressive therapy
• Diagnosed with arrhythmia, ventricular extrasystole or atrioventricular block
• Diagnosed with a cardiovascular disease
• Diagnosed with a severe systemic disease e.g. cancer, dementia, advanced organ failure.
• Unexplained loss of weight in recent months

Sponsors & Collaborators

• Cultech Ltd: lead
• Comac Medical: collaborator

Study Sites (1)

Comac Medical

Sofia, Bulgaria

Location

Study Officials

• Daryn Michael, PhD

  Cultech Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 18, 2024
• Study Start: July 30, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

BU (1)