Health TrialsbyHealthPanel

Synbiotic to Attenuate Resorption of the Skeleton

ConditionsOsteoporosisInflammationAging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorHebrew SeniorLife

About this trial

This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Provided written informed consent.

2. Stated availability throughout entire study period and willingness to fulfill all details of the protocol.

3. Age 60 years and above.

4. DXA-BMD of the hip and spine (T-score) > -2.5. Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care use of osteoporosis medications for the entire duration of their participation in the study.

Disqualifiers

1. BMI greater than 40 kg/m2.

2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and unwilling to avoid these supplements for the duration of the study.

3. Participants using osmotic laxatives >1 per week and unwilling to avoid use for the duration of the study.

4. Known or suspected allergies to probiotics, rice, edible fruit extract or berries.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBD111 medical food

    Other intervention

    SBD111 medical food is a defined microbial assemblage (DMA) consisting of oligofructose and dried berry powder (prebiotics), a Pseudomonas fluorescens, a Lactobacillus brevis, a Leuconostoc mesenteroides, a Lactobacillus plantarum, and a Pichia kudriavzevii (yeast).

  • Placebo

    Other intervention

    Placebo

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: SBD111 medical foodExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lumbar spine BMD (g/cm2)

BMD of the lumbar spine (L1-L4) will be measured at the baseline exam, 9-month, and 18-month final follow-up visit

Time frame
Change over 18 months

Secondary outcomes

1

Vertebral compressive strength (N)

Quantitative computed tomography (QCT) scans acquired at baseline and 18-months will be used to estimate vertebral compressive bone strength using Biomechanical Computed Tomography (BCT, VirtuOst, O.N. Diagnostics, Berkeley, CA).

Time frame
Change over 18 months
2

volumetric BMD

Measurements of integral and vertebral trabecular vBMD at L1-L3.

Time frame
Change over 18 months
3

C-terminal cross-linked telopeptide of type I collagen (β-CTX)

A biochemical marker of bone resorption

Time frame
Change over 18 months
4

Procollagen Type I Intact N-terminal Propeptide (P1NP)

A biochemical marker of bone formation

Time frame
Change over 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebrew SeniorLife

Lead sponsor

Solarea Bio, Inc

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Tufts University

Collaborator

MaineHealth

Collaborator

Source ClinicalTrials.gov
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