Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-16
Brief Title:
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
Sponsor:
Nordic Biotic Sp z oo
Organization:
Nordic Biotic Sp z oo
Study Overview
Official Title:
The Effect of the Probiotic Strains Lactobacillus Plantarum and Lactobacillus Paracasei on Bone Mineral Density in Postmenopausal Women - a Multicenter Randomized Placebo-controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture with the resulting greater bone fragility leading to fractures Osteoporosis develops as a result of genetic and environmental factors with the patients lifestyle playing an important role Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis thus new ways of modifying the composition and activity of microbiota have been sought and the potential role of probiotics has been considered Probiotics are defined as live microorganisms which-when administered at appropriate doses-are beneficial to the hosts health Probiotics both modify the gut microbiota composition and directly affect the human body Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine L1-L4 Study subjects will take the provided probiotic formulationplacebo orally once daily for 12 months
Detailed Description:
The main purpose of the study is to assess the effect of oral probiotic supplementation on bone mineral density in postmenopausal women A total of 170 female subjects who meet all the inclusion criteria and none of the exclusion criteria are to be included and randomized to one of two arms the probiotic arm or the placebo arm at a ratio of 11
The subjects who provide their written informed consent will receive oral probiotic formulation containing a mixture of two strains Lactobacillus plantarum and Lactobacillus paracasei or placebo The probiotic formulation and placebo will be provided by Nordic Biotic Ltd the company will also ensure study drug blinding Study subjects will take the provided probiotic formulationplacebo orally once daily for 12 months
The study timeline spans 54 weeks and involves 13 visits including
1 Screening visit - subjects eligibility to participate in the study will be assessed based on the inclusionexclusion criteria - the screening period will last up to 14 before the study drug is administered
2 Randomization visit visit 0 - subjects will be randomly allocated to study groups and will receive a supply of the study probiotic or placebo
3 6 office visits at months 2 4 6 8 10 and 12 of visit 0
4 5 remote visits at months 1 3 7 9 and 11 of visit 0
All subjects included in the study will undergo
History-taking and physical examination at each office visit
Nutritional status assessment measurements of body weight and height with a BMI calculation at the screening visit and at months 6 and 12 of the study intervention
Two densitometry scans DEXA of the lumbar segment of the spine L1-L4 at the screening visit and at month 12 of visit 0
Treatment satisfaction assessment treatment satisfaction questionnaire at months 2 6 10 and 12 of the study intervention
At each visit whether conducted at the doctors office or remotely subjects will be asked about their use of the study drug and any gastrointestinal symptoms number of bowel movements stool consistency bloating abdominal pain and the use of any other medications including antibiotics Each time the subjects will be also asked about any side effects Stool consistency will be assessed with the Bristol Stool Form Scale and abdominal pain bloating and nausea will be assessed with a 5-grade Likert scale
Blood samples will be collected from all subjects during the screening period after 6 months of intervention and at the completion of intervention ie at month 12
The following blood tests will be conducted
1 Complete blood count erythrocyte sedimentation rate and C-reactive protein levels at screening and at months 6 and 12 of the study intervention
2 Serum calcium phosphorus and alkaline phosphatase levels at screening and at months 6 and 12 of the study intervention
3 Serum vitamin D and parathormone levels at screening and at month 12 of intervention
The subjects who provide their written informed consent will receive oral probiotic formulation containing a mixture of two strains Lactobacillus plantarum and Lactobacillus paracasei or placebo The probiotic formulation and placebo will be provided by Nordic Biotic Ltd the company will also ensure study drug blinding Study subjects will take the provided probiotic formulationplacebo orally once daily for 12 months
The study timeline spans 54 weeks and involves 13 visits including
1 Screening visit - subjects eligibility to participate in the study will be assessed based on the inclusionexclusion criteria - the screening period will last up to 14 before the study drug is administered
2 Randomization visit visit 0 - subjects will be randomly allocated to study groups and will receive a supply of the study probiotic or placebo
3 6 office visits at months 2 4 6 8 10 and 12 of visit 0
4 5 remote visits at months 1 3 7 9 and 11 of visit 0
All subjects included in the study will undergo
History-taking and physical examination at each office visit
Nutritional status assessment measurements of body weight and height with a BMI calculation at the screening visit and at months 6 and 12 of the study intervention
Two densitometry scans DEXA of the lumbar segment of the spine L1-L4 at the screening visit and at month 12 of visit 0
Treatment satisfaction assessment treatment satisfaction questionnaire at months 2 6 10 and 12 of the study intervention
At each visit whether conducted at the doctors office or remotely subjects will be asked about their use of the study drug and any gastrointestinal symptoms number of bowel movements stool consistency bloating abdominal pain and the use of any other medications including antibiotics Each time the subjects will be also asked about any side effects Stool consistency will be assessed with the Bristol Stool Form Scale and abdominal pain bloating and nausea will be assessed with a 5-grade Likert scale
Blood samples will be collected from all subjects during the screening period after 6 months of intervention and at the completion of intervention ie at month 12
The following blood tests will be conducted
1 Complete blood count erythrocyte sedimentation rate and C-reactive protein levels at screening and at months 6 and 12 of the study intervention
2 Serum calcium phosphorus and alkaline phosphatase levels at screening and at months 6 and 12 of the study intervention
3 Serum vitamin D and parathormone levels at screening and at month 12 of intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None