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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05009875




Registration number
NCT05009875
Ethics application status
Date submitted
10/08/2021
Date registered
18/08/2021
Date last updated
13/05/2024

Titles & IDs
Public title
Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
Scientific title
Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
Secondary ID [1] 0 0
SOL-SYNBIOTIC-2021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Medical Food SBD111
Other interventions - Placebo

Experimental: SBD111 -

Placebo Comparator: Placebo -


Other interventions: Medical Food SBD111
Two capsules administered twice daily with morning and evening meals for 52 weeks

Other interventions: Placebo
Two capsules administered twice daily with morning and evening meals for 52 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks
Timepoint [1] 0 0
Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Secondary outcome [1] 0 0
Change in Bone Mineral Density (BMD) at the femoral neck from baseline to 52 weeks
Timepoint [1] 0 0
Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Secondary outcome [2] 0 0
Change in Bone Mineral Density (BMD) at the hip from baseline to 52 weeks
Timepoint [2] 0 0
Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Secondary outcome [3] 0 0
Change in volumetric BMD (vBMD) measured by quantitative computed tomography (QCT) at the lumbar spine from baseline to 52 weeks
Timepoint [3] 0 0
Change in volumetric BMD (vBMD) from baseline to 52 weeks
Secondary outcome [4] 0 0
Change in circulating C-Reactive Protein (CRP) from baseline to 52 weeks
Timepoint [4] 0 0
Change from baseline to 52 weeks
Secondary outcome [5] 0 0
Change in circulating Interleukin-17 (IL-17) from baseline to 52 weeks
Timepoint [5] 0 0
Change from baseline to 52 weeks
Secondary outcome [6] 0 0
Change in circulating Tumor Necrosis Factor (TNF) from baseline to 52 weeks
Timepoint [6] 0 0
Change from baseline to 52 weeks
Secondary outcome [7] 0 0
Change in circulating Interleukin-4 (IL-4) from baseline to 52 weeks
Timepoint [7] 0 0
Change from baseline to 52 weeks
Secondary outcome [8] 0 0
Change in circulating receptor activator of nuclear factor kappa beta ligand (RANKL) from baseline to 52 weeks
Timepoint [8] 0 0
Change from baseline to 52 weeks
Secondary outcome [9] 0 0
Change in circulating Interferon gamma (IFNy) from baseline to 52 weeks
Timepoint [9] 0 0
Change from baseline to 52 weeks
Secondary outcome [10] 0 0
Change in circulating C-terminal telopeptide of type 1 collagen (CTX) from baseline to 52 weeks
Timepoint [10] 0 0
Change from baseline to 52 weeks
Secondary outcome [11] 0 0
Change in circulating Procollagen 1 Intact N-Terminal Propeptide (P1NP) from baseline to 52 weeks
Timepoint [11] 0 0
Change from baseline to 52 weeks
Secondary outcome [12] 0 0
Safety as assessed by incidence of adverse events and serious adverse events
Timepoint [12] 0 0
Change from baseline to 52 weeks
Secondary outcome [13] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [13] 0 0
Change from baseline to 1-week
Secondary outcome [14] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [14] 0 0
Change from baseline to 2-weeks
Secondary outcome [15] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [15] 0 0
Change from baseline to 3-weeks
Secondary outcome [16] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [16] 0 0
Change from baseline to 4-weeks
Secondary outcome [17] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [17] 0 0
Change from baseline to 3-months
Secondary outcome [18] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [18] 0 0
Change from baseline to 6-months
Secondary outcome [19] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [19] 0 0
Change from baseline to 9-months
Secondary outcome [20] 0 0
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Timepoint [20] 0 0
Change from baseline to 12-months
Secondary outcome [21] 0 0
Change from baseline in the global Menopause Rating Scale (MRS)
Timepoint [21] 0 0
Change from baseline to 3-months
Secondary outcome [22] 0 0
Change from baseline in the global Menopause Rating Scale (MRS)
Timepoint [22] 0 0
Change from baseline to 6-months
Secondary outcome [23] 0 0
Change from baseline in the global Menopause Rating Scale (MRS)
Timepoint [23] 0 0
Change from baseline to 9-months
Secondary outcome [24] 0 0
Change from baseline in the global Menopause Rating Scale (MRS)
Timepoint [24] 0 0
Change from baseline to 12-months

Eligibility
Key inclusion criteria
- Written informed consent

- Stated availability throughout entire study period (12 months) and willingness to
fulfill all details of the protocol

- In early postmenopause (at least 1 year but a maximum of 6 years since the last
menstruation)

- At least 6-months since the last intake of hormone replacement therapy

- Dual energy X-ray absorptiometry (DXA)-derived Bone Mineral Density (BMD) T-score of
greater than -2.5 at the lumbar spine (L1-L4), femoral neck, and total hip but no site
with BMD = -2.5

- Body Mass Index between 18.5 and 35 kg/m2

- Normal levels of serum calcium (<11mg/dL)

- Normal cardiovascular parameters (systolic blood pressure = 155 mm Hg, diastolic blood
pressure = 95 mm Hg) healthy and medication controlled
Minimum age
45 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The presence of any of the following criteria will exclude the participant from
participating in the study:

- History of other bone disorders (eg. Paget's disease, or osteomalacia, osteogenesis
imperfecta, osteopetrosis, osteoporosis, etc.)

- Women who have had cancer and were treated with radiation therapy, anti-estrogen
therapy, hormonal therapy, or aromatase inhibitors

- Any history of bone or colon cancer

- Autoimmune disorders (rheumatoid arthritis, Hashimoto's disease, Graves' disease,
ect), uncontrolled type 2 diabetes, gastrointestinal disorders (ulcerative colitis,
Crohn's disease, inflammatory bowel disease, irritable bowel syndrome), kidney disease
or dysfunction or any other medical condition that could interfere with the conduct of
the study.

- History of chronic antibiotic use

- History of bariatric surgery

- History of partial colectomy

- Women with spine abnormalities that would prohibit assessment of BMD

- Women who have undergone hip joint replacement

- Women who have undergone a partial hysterectomy

- Women with untreated hyperparathyroidism

- Women previously treated with calcitonin, estrogens, estrogen derivatives, selective
estrogen receptor modulators (SERMs), tibolone, progestins, anabolic steroids, or
daily glucocorticoids in the past 6 months

- Women treated with bisphosphonates or strontium in the past 5 years

- Women previously treated with PTH, PTH analogs, gallium nitrate, romosozumab or
denosumab

- Per-oral use of corticosteroids

- Smoking or use of nicotine products within the past 6-months

- Any disease, that by the investigator's judgement, could interfere with the intestinal
barrier function

- Participation in other bone, diet, autoimmune, or gastrointestinal related clinical
trials in the last 6 months

- Desire and/or plans on changing current diet and/or exercise regime during the
participation of this trial

- Pregnancy or lactation

- Consumption of dietary supplements (probiotics, prebiotics) in the month prior to or
during study (if participant is willing to stop taking these for 1-month, they can be
enrolled after a 1-month washout period)

- Consumption of antibiotics in the past 2 months (if participant is placed on an
antibiotic after enrolment in the study, will be subject to a per protocol analysis)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
286
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Newstead
Recruitment postcode(s) [1] 0 0
4006 - Newstead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Solarea Bio, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the trial is to determine if the SYNBIOTIC (prebiotic and probiotic), provided
twice daily (capsule) will help support skeletal health in otherwise healthy postmenopausal
women in the early years postmenopause (1-6 years post last menstruation) over a 12-month
period.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05009875
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05009875