FemaleProWOMENCT06507111
The Impact of Probiotics on Well-being in Women
A study testing Lab4P in people with Female and Healthy Aging, run by Cultech Ltd at 1 site in Bulgaria.
Trial summary
An exploratory study to determine whether daily supplementation with a probiotic product impacts the overall well-being of women aged between 45 - 65 Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female, Healthy Aging
- What is being tested?
- Lab4P
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Jul 2024to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Female, Healthy Aging
- Being tested
- Lab4P, Placebo
- Keywords
- Well-being, Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab4PDietary 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
PlaceboOther
MCC alone
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Lab4P Multi-strain Probiotic (comprising Lactobacilli and bifidobacteria species) with Vitamin C, Vitamin D and Zinc Receives: Dietary Supplement: Lab4P |
| Placebo | Placebo comparator | Matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: At Day 1, Day 56 and Day 112 ± 3 after trial start
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 1 and Day 112 ± 3 after trial start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start30 Jul 2024
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cultech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comac Medical
- Responsible party
- Sponsor
- Investigators
- Daryn Michael, PhD, Principal investigator, Cultech Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507111
- Sponsor's protocol ID
- ProWOME
- Acronym
- ProWOME
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Michael DR, Coates N, Kerry-Smith J, John DA, Hulme E, Owen L, Plummer SF. Probiotic supplementation improves well-being and anxiety in healthy women: An exploratory, randomized, double-blind, placebo-controlled study. Gut Microbes Rep. 2025 Sep 5;2(1):2543125. doi: 10.1080/29933935.2025.2543125. eCollection 2025.
PubMed 41909887
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Probiotic Supplementation on the Well-being of Women.
- ClinicalTrials.gov ID
- NCT06507111
- Acronym / sponsor ID
- ProWOME / ProWOME
- Conditions
- Female, Healthy Aging
- Keywords
- Well-being, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cultech LtdIndustry (pharma, biotech, devices)
- Collaborators
- Comac Medical
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An exploratory study to determine whether daily supplementation with a probiotic product impacts the overall well-being of women aged between 45 - 65
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Lab4PLab4P Multi-strain Probiotic (comprising Lactobacilli and bifidobacteria species) with Vitamin C, Vitamin D and Zinc |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab4PLactobacillus 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 | Dietary supplement | Active |
| PlaceboMCC alone | Other | Placebo |
Primary outcome
Quality of Life Questionnaire
Time frame: At Day 1, Day 56 and Day 112 ± 3 after trial start
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".
Sleep Quality Questionnaire
Time frame: At Day 1, Day 56 and Day 112 ± 3 after trial start
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.
Mood Questionnaire
Time frame: At Day 1, Day 56 and Day 112 ± 3 after trial start
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.
5 secondary outcomes
Weekly Well-being Diary
Time frame: 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
Time frame: At Day 1 and Day 112 ± 3 after trial start
Bacterial composition of vaginal samples via sequencing
Time frame: At Day 1 and Day 112 ± 3 after trial start
Blood plasma analysis for plasma lipids
Time frame: At Day 1 and Day 112 ± 3 after trial start
Blood plasma analysis inflammatory markers
Time frame: At Day 1 and Day 112 ± 3 after trial start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 41909887Michael DR, Coates N, Kerry-Smith J, John DA, Hulme E, Owen L, Plummer SF. Probiotic supplementation improves well-being and anxiety in healthy women: An exploratory, randomized, double-blind, placebo-controlled study. Gut Microbes Rep. 2025 Sep 5;2(1):2543125. doi: 10.1080/29933935.2025.2543125. eCollection 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryn Michael, PhD principal investigator
Cultech Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab4P in people with Female and Healthy Aging, run by Cultech Ltd at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: At Day 1, Day 56 and Day 112 ± 3 after trial start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06507111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.