Trial Outcomes & Findings for Lactobacillus Acidophilus and Postmenopausal Women (NCT NCT05332626)
NCT ID: NCT05332626
Last Updated: 2026-01-08
Results Overview
measure the calcium concentration in serum and hair
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
2 years
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
Probiotic Group
Participants received a daily capsule containing Lactobacillus acidophilus UALa-01™ (1×10⁹ CFU) for 12 weeks to evaluate its effect on postmenopausal osteoporosis.
|
Placebo Group
Participants received a daily placebo capsule containing maize starch and maltodextrins for 12 weeks as a control for evaluating the probiotic intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
30
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Probiotic Group
n=32 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=32 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 6.5 • n=32 Participants
|
56.5 years
STANDARD_DEVIATION 5.8 • n=32 Participants
|
58.1 years
STANDARD_DEVIATION 6.3 • n=64 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Poland
|
32 participants
n=32 Participants
|
32 participants
n=32 Participants
|
64 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 2 yearsmeasure the calcium concentration in serum and hair
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Calcium
|
1.88 mmol/L
Standard Deviation 0.44
|
2.04 mmol/L
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 2 yearsbone densitometry analysis
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
DXA
|
1.12 g/cm2
Standard Deviation 0.12
|
1.15 g/cm2
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 2 yearsmeasure body mass in kilograms
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Body Mass
|
72.22 kg
Standard Deviation 15.21
|
73.88 kg
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: 2 yearsassessing calcium intake with the questionnaire
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Calcium Intake
|
1,115.81 gram
Standard Deviation 529.76
|
894.72 gram
Standard Deviation 381.84
|
SECONDARY outcome
Timeframe: 2 yearsmeasure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Biomarkers of Bone Turnover: CTX
|
5.67 pg/ml
Standard Deviation 0.52
|
5.11 pg/ml
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 2 yearsmeasure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Biomarkers of Bone Turnover: TRAP5b
|
26.09 ng/ml
Standard Deviation 9.31
|
21.13 ng/ml
Standard Deviation 6.33
|
SECONDARY outcome
Timeframe: 2 yearsmeasure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Biomarkers of Bone Resorption: BSAP
|
10.90 ng/ml
Standard Deviation 1.56
|
11.38 ng/ml
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 2 yearsmeasure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
Outcome measures
| Measure |
Probiotic Group
n=30 Participants
The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10\^9 CFU for 12 weeks
Probiotic group: The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10\^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
|
Placebo Group
n=25 Participants
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Placebo group: The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
|
|---|---|---|
|
Biomarkers of Bone Resorption: PINP
|
2.64 ng/ml
Standard Deviation 0.52
|
2.66 ng/ml
Standard Deviation 0.52
|
Adverse Events
Probiotic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place