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Completed

NCT Number: NCT05332626

Lactobacillus Acidophilus and Postmenopausal Women

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.

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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, Greater Poland Voivodeship, 60-624, Poland

About this study

This study has three steps; namely, 1st step is to prepare the diet supplementation of probiotics and placebo. 2nd step is to perform the randomized, double-blind placebo-controlled clinical trial. 3rd step is to analyze the effects of L. acidophilus UALa-01™ in postmenopausal women.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • History of following alternative diets (diets with the altered amount of macronutrients, vegan or vegetarian diets, high-fiber diet, a diet with high quantities of fermented food (>400 g/day), diet fortified with prebiotics- and probiotics-functional food, elimination diets, low-calorie diets) within three months before the study;
  • History of use of any dietary supplements, including calcium, in the three months before the study;
  • History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
  • Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
  • Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
  • Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
  • Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
  • Diseases requiring nutritional requirement and chronic supplementation;
  • Alcohol (>20g/d), nicotine or drug abuse;
  • Mental disorders, including eating disorders;
  • Cancer, autoimmune diseases;
  • Any other condition that, in the opinion of the investigators, would make participation not in the best interest of the subject, or could prevent, limit, or confound the efficacy of the study any diseases, disorders, and therapies, which may influence on final results of the study or pose a risk for subjects health.

Treatment and study plan

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)

Primary outcomes

  1. Calcium

    Time frame: 2 years

    measure the calcium concentration in serum and hair

  2. DXA

    Time frame: 2 years

    bone densitometry analysis

Secondary outcomes

  1. Body Mass

    Time frame: 2 years

    measure body mass in kilograms

  2. Calcium Intake

    Time frame: 2 years

    assessing calcium intake with the questionnaire

  3. Biomarkers of Bone Turnover: CTX

    Time frame: 2 years

    measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum

  4. Biomarkers of Bone Turnover: TRAP5b

    Time frame: 2 years

    measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum

  5. Biomarkers of Bone Resorption: BSAP

    Time frame: 2 years

    measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum

  6. Biomarkers of Bone Resorption: PINP

    Time frame: 2 years

    measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Collaborators

  • Poznan University of Medical Sciences

Registry information

Official study title

Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal in Women?

Acronym: LaBon

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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