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Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05009875
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Solarea Bio, Inc

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.

Condition or disease Intervention/treatment Phase
Osteopenia Other: Medical Food SBD111 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : April 1, 2023

Arm Intervention/treatment
Experimental: SBD111 Other: Medical Food SBD111
Two capsules administered twice daily with morning and evening meals for 52 weeks

Placebo Comparator: Placebo Other: Placebo
Two capsules administered twice daily with morning and evening meals for 52 weeks




Primary Outcome Measures :
  1. Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks [ Time Frame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks ]
    Change in Bone Mineral Density (BMD) at lumbar spine following an administration period of 52 weeks and measured by DXA



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 -2.49 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 32.5 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

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, etc.)
  • History of cancer other than skin cancer, autoimmune disorders (rheumatoid arthritis, hashimoto's, graves' disease, ect) 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 any joint replacement (hip, knee, etc.)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05009875


Contacts
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Contact: Eric Schott, PhD 585-704-8069 eschott@solareabio.com

Locations
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Australia, Queensland
RDC Clinical Recruiting
Newstead, Queensland, Australia, 4006
Contact: Amanda Rao    61-731-024-486    amanda@rdcglobal.com.au   
Sponsors and Collaborators
Solarea Bio, Inc
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Responsible Party: Solarea Bio, Inc
ClinicalTrials.gov Identifier: NCT05009875    
Other Study ID Numbers: SOL-SYNBIOTIC-2021
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases