Lactobacillus Acidophilus and Postmenopausal Women

What this trial studies

This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.

Conditions in scope

• Bone Loss
• Post Menopausal Osteoporosis
• Mineralization

Interventions

• Probiotic group (Dietary Supplement) — 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 (Dietary Supplement) — The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)

Who can join

Women only · Ages 45 Years to 70 Years

Inclusion criteria

• Women aged 45 to 70 years old with more than one year since last menstruation;
• Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
• All female participants who accepted bone densitometry measurement

Exclusion criteria

• The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
• Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
• Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
• Clinically significant acute inflammatory process (elevated hsCRP)
• Abnormal kidney function (GFR \<60mL/min/1,73m2);
• Participation in a body mass management study;
• The use of drugs known to modify body mass or food intake;
• Hormone replacement therapy;

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2022-02-01
• Primary completion: 2024-07-01
• Last update posted: 2026-01-08
• First posted: 2022-04-18

Sponsor & contact

Lead sponsor: Poznan University of Life Sciences (Other)

Collaborators: Poznan University of Medical Sciences

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Calcium (2 years)
  measure the calcium concentration in serum and hair
• DXA (2 years)
  bone densitometry analysis

Related ClearedRx care

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