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

Sponsor

Solarea Bio, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05009875

Collaborator

(none)

300

Enrollment

Location

Arms

15.5

Anticipated Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 15, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RDC Clinical	Newstead	Queensland	Australia	4006

Sponsors and Collaborators

Solarea Bio, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Solarea Bio, Inc

ClinicalTrials.gov Identifier:

NCT05009875

Other Study ID Numbers:

SOL-SYNBIOTIC-2021

First Posted:

Aug 18, 2021

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Diseases, Metabolic

Study Results

No Results Posted as of Jan 28, 2022