Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase

NCT02722980 | Completed

• 1 other identifier: ProBone16
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the current study is to evaluate the efficacy of a probiotic product on bone mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of 12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes in bone turnover markers during the period of 12 months.

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

• Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.

  Change in BMD from baseline to 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsules

Dietary Supplement: Placebo

Active

ACTIVE COMPARATOR

Capsules.

Dietary Supplement: : Probiotic capsules

Interventions

Placebo DIETARY_SUPPLEMENT

The intervention consists of capsules containing placebo.

Placebo

: Probiotic capsules DIETARY_SUPPLEMENT

The intervention consists of capsules containing probiotics.

Active

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Healthy women in early post-menopausal phase (at least two \[2\] years but a maximum of 12 years since the last menstruation and at least one \[1\] year since the last intake of hormone replacement therapy).
• BMI ≥ 18 and ≤ 30 at screening.
• BMD T-score in the lumbar spine (L1-L4) \> -2.5, as measured by DXA.
• Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.
• Ability to understand and comply with the requirements of the study, as judged by the Investigator.

You may not qualify if:

• Relevant history of \>1 previous fracture after 50 years of age, as judged by the Investigator.
• T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.
• History of metabolic bone disease.
• Unstable weight (± five \[5\] kg) during the last six (6) months.
• History of hyperthyroidism or unstable hypothyroidism.
• Diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease (IBD), celiac disease or diabetes.
• Known history of rheumatoid arthritis, clinically significant kidney or heart disease, as judged by the Investigator.
• Gastric bypass surgery performed.
• History of immunodeficiency or immunosuppressive treatment.
• Chronic or acute diarrheal disease.
• Recently diagnosed malignancy (within the last five \[5\] years).
• Use of products containing probiotic bacteria (more than once per week) within four (4) weeks prior to baseline.
• Per-oral use of corticosteroids.
• Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.
• Use of any anti-resorptive therapy, including e.g. systemic hormone replacement therapy, bisphosphonates (currently or during last 12 months)

Sponsors & Collaborators

• Probi AB: lead

Study Sites (2)

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Uppsala, Sweden

Location

Related Publications (1)

• Jansson PA, Curiac D, Lazou Ahren I, Hansson F, Martinsson Niskanen T, Sjogren K, Ohlsson C. Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2019 Nov;1(3):e154-e162. doi: 10.1016/S2665-9913(19)30068-2. Epub 2019 Oct 23.

  PMID: 38229392 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dan Curiac

  Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 30, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)