The Impact of Probiotics on Well-being in Women (ProWOME)

The Impact of Probiotic Supplementation on the Well-being of Women.

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

Study Overview

• Status: Completed
• Conditions: Healthy Aging; Female
• Intervention / Treatment: Dietary supplement: Lab4P; Other: Placebo

Detailed Description

It is generally accepted that there is a gradual decline in general well-being associated with aging. In previous studies with healthy adults receiving the Lab4P probiotic the outcomes indicated an overall improvement in general well-being and these findings provide the focus for the current trial which is investigating whether daily supplementation with the Lab4P probiotic product can impact upon the well-being of a cohort of women aged between 45 - 65 years (peri-menopausal/menopausal/post-menopausal).

The trial will be a double blinded, 2-arm, randomized, placebo-controlled, parallel group superiority study consisting of 50 women (gender as assigned at birth), aged between 45-65. The randomisation scheme will be generated by using a web-based interface using 1:1 allocation into 2 groups (block size 2).

The participants will make two site visits, the first visit for enrolment when they will be randomised, allocated their appropriate study product and their height, body weight and blood pressure will be measured. They will also be given a series of questionnaires assessing sleep (Athen Insomnia Scale), Mood (Hospital Anxiety and Depression Scale) and Quality of Life (Menopause Rating Scale) together with two cognitive tests (Word colour Stroop and Rey Auditory Verbal Learning Test (RAVLT)) to complete. A blood sample, a stool sample and a vaginal swab will be collected at this visit (if possible) and the participant will be given sample collection kits to take with them to collect futher samples prior to their second visit. They will be given a copy of each of the questionnaires and requested to be completed them and return by post at the study midpoint (day 56). They will also receive a copy of a Well-being diary that they will be asked to complete weekly throughout the study.

The second visit will take place at the end of the study (around day 112) and at that time the participants will bring the stool sample and vaginal swab collected at home and provide the final blood sample. At this time the participants will also complete each of the questionnaires (sleep, mood and quality of life) on site and repeat the Word Colour Stroop and RAVLT tests. The completed weekly Well-being diaries and any unused intervention will be returned. Scientists will use the information and samples collected to assess the benefits of taking the probiotic supplement.

It is considered that the daily intake of the probiotics will improve general wellbeing and mental health. Due to the chance that the use of the placebo, it is possible that any benefits will be confined to the participants who are randomly assigned the probiotic product. It is envisaged that the results generated from this study will enhance and improve our understanding of the benefits of daily probiotic supplementation.

There is no record of any adverse reactions associated with the regular consumption of this probiotic product but participants may experience mild side effects such as a change in bowel habit and/ or increased flatulence (intestinal gas) during the first few days of taking the supplement.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Comac Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Women aged 45 to 65
2. Willing to provide faecal samples, blood samples and vaginal swabs
3. BMI of less than 30 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
6. Normal (or corrected-to-normal) vision without colour blindness in order to complete the cognitive task

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Other: Placebo; MCC alone
Active Comparator: Active; Lab4P Multi-strain Probiotic (comprising Lactobacilli and bifidobacteria species) with Vitamin C, Vitamin D and Zinc	Dietary supplement: Lab4P; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Well-being Diary	Weekly well-being diary to evaluate the participants general well-being post probiotic supplementation. This well-being diary records the frequency of days in the week that symptoms were experienced, this is between 1 - 7.	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	Shotgun metagenomic sequencing analysis to assess the bacterial composition of the faecal microbiome.	At Day 1 and Day 112 ± 3 after trial start
Bacterial composition of vaginal samples via sequencing	Shotgun metagenomic sequencing analysis to assess the bacterial composition of the vaginal microbiome.	At Day 1 and Day 112 ± 3 after trial start
Blood plasma analysis for plasma lipids	Blood plasma samples analysed for plasma lipids such as cholesterol and triglycerides.	At Day 1 and Day 112 ± 3 after trial start
Blood plasma analysis inflammatory markers	Blood plasma samples analysed for plasma inflammatory markers such as IL-1B, TNFa, IL6, IL8, CCL2.	At Day 1 and Day 112 ± 3 after trial start

Collaborators and Investigators

• Sponsor: Cultech Ltd
• Collaborators: Comac Medical
• Investigators: Principal Investigator: Daryn Michael, PhD, Cultech Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Probiotic; Well-being
• Other Study ID Numbers: ProWOME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No