Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri

NCT04169789 | Completed

• 1 other identifier: ELBOWII
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of two different doses of Lactobacillus reuteri ATCC PTA 6475 (L.reuteri 6475) on bone loss in early postmenopausal women. One third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Total tibia volumetric bone mineral density

  Measured using high resolution peripheral computed tomography (HRpQCT), relative change 0-24 months

  24 months

Secondary Outcomes (12)

• Areal bone mineral density (aBMD) at the lumbar spine

  24 months

• Areal BMD of the total hip (DXA)

  0-24 months and 0-12 months

• Tibia trabecular bone volume fraction

  0-24 months and 0-12 months

• Tibia cortical area

  0-24 months and 0-12 months

• Tibia cortical volumetric BMD

  0-24 months and 0-12 months

Study Arms (3)

L. reuteri Low Dose

ACTIVE COMPARATOR

Capsules of freeze-dried L. reuteri 6475 of 5x10E8 colony-forming units (CFU) mixed with maltodextrin powder and 200 IU of cholecalciferol, taken twice daily for 24 months, yielding a total dose of either 1x10E9 L.reuteri CFU and 400 IU of cholecalciferol per day.

Dietary Supplement: Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

L. reuteri High Dose

ACTIVE COMPARATOR

Capsules of freeze-dried L. reuteri 6475 of 5x10E9 colony-forming units (CFU) mixed with maltodextrin powder and 200 IU of cholecalciferol, taken twice daily for 24 months, yielding a total daily dose of 1x10E10 L.reuteri CFU and 400 IU of cholecalciferol per day.

Dietary Supplement: Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

Placebo

PLACEBO COMPARATOR

Placebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 24 months.The placebo product contains 200 IU cholecalciferol per dose, yielding a total dose of cholecalciferol of 400 IU per day.

Dietary Supplement: Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

Interventions

Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475) DIETARY_SUPPLEMENT

L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.

L. reuteri High Dose; L. reuteri Low Dose; Placebo

Eligibility Criteria

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

You may qualify if:

• Postmenopausal women, 45 years or older, within 1-4 years from their last menses.
• Vitamin D levels above 25 nmol/L.
• Signed informed consent.
• Stated availability throughout the entire study period.
• Ability to understand study instructions and willingness to adhere to the protocol.

You may not qualify if:

• Bone mineral density of \< -2.5 combined with a fracture risk assessment tool (FRAX) score of 20% or higher for major osteoporotic fracture.
• Severe osteoporosis, defined as bone mineral density of \< -3.0 in either the total hip, femur neck or lumbar spine L1-L4.
• Vertebral fracture (grade II or III) diagnosed using lateral spine imaging with DXA.
• Untreated hyperthyroidism or hyperthyroidism within the last 5 years.
• Known untreated hyperparathyroidism.
• Rheumatoid arthritis.
• Diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus.
• Recently diagnosed malignancy (within the last 5 years).
• Oral corticosteroid use.
• Previous (within the last 5 years) use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab.
• Systemic skeletal disease (including e.g. Paget's disease and osteogenesis imperfecta).
• Any systemic disease that could affect bone loss, as judged by the investigator.
• Use of teriparatide (current or during the last 3 years).
• Participation in other clinical trials.
• Current and within the past 2 months use of probiotic supplement

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• BioGaia AB: collaborator

Study Sites (1)

Geriatric Medicine, Sahlgrenska University Hospital, Mölndal

Gothenburg, Västra Götaland County, 43180, Sweden

Location

Related Publications (2)

• Nilsson AG, Sundh D, Backhed F, Lorentzon M. Lactobacillus reuteri reduces bone loss in older women with low bone mineral density: a randomized, placebo-controlled, double-blind, clinical trial. J Intern Med. 2018 Sep;284(3):307-317. doi: 10.1111/joim.12805. Epub 2018 Jul 22.

  PMID: 29926979 BACKGROUND

• Gregori G, Pivodic A, Magnusson P, Johansson L, Hjertonsson U, Brattemark E, Lorentzon M. Limosilactobacillus reuteri 6475 and Prevention of Early Postmenopausal Bone Loss: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415455. doi: 10.1001/jamanetworkopen.2024.15455.

  PMID: 38865129 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mattias Lorentzon, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: December 4, 2019
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)