Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507111
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
The Impact of Probiotics on Well-being in Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Probiotic Supplementation on the Well-being of Women
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProWOME
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
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-menopausalmenopausalpost-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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None