Recruiting

SynbioticSynbiotic to Attenuate Resorption of the Skeleton

Sponsor:

Hebrew SeniorLife

Code:

NCT06389539

Conditions

Osteoporosis

Inflammation

Aging

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Accepted

Interventions

SBD111 medical food

Placebo

Study Details

Brief summary:

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

Conditions

Osteoporosis

Inflammation

Aging

Study ID

NCT06389539

Start date

Aug 12, 2024

Status verified date

Mar, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.
5\. Women with a history of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years will be considered if they are not currently using osteoporosis medications, or if they have decided not to accept the standard of care osteoporosis medications, even if diagnosed with osteoporosis during the screening procedure.
6\. Serum 25-hydroxyvitamin D ≥ 20 ng/mL.
7\. Normal renal function (eGFR >50 ml/min).
8\. Have chosen to not accept the standard of care use of osteoporosis medications for the duration of the study.
9\. Willing to comply with protocol and report on compliance and side effects during the study period.

Exclusion Criteria:

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.
5\. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained.
6\. History of drug and/or alcohol abuse at the time of enrolment.
7\. Presence of any of the following:
a. History of other bone disorders (e.g. Paget's disease).
b. History of moderate to severe scoliosis.
c. History of cancer other than skin cancer <5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes.
d. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease or any chronic bowel condition.
e. Women with untreated hyperparathyroidism.
f. History of chronic antibiotic use.
g. History of bariatric surgery.
h. History of partial colectomy.
i. History of pancreatic disease.
j. History of active hepatitis B, hepatitis C, cirrhosis, metabolic dysfunction-associated steatotitc liver disease (MASLD), fatty liver or chronic liver disease.
k. Current bone marrow disorders such as myelodysplastic syndrome or anemia requiring transfusions.
l. Abnormalities of the spine determined by the study physician to interfere with the assessment of bone mineral density.
m. Current smoking or use of nicotine products within the past 6 months.
n. Current use of marijuana and unwilling to abstain during the study period.
o. Major abdominal surgery within the last 3 months.
p. Colonoscopy within the last 1 month.
q. Colonoscopy planned in the next 18 months and unwilling to reschedule it.
r. Indwelling catheter, implanted hardware/prosthetic device or feeding tube.
s. Any medical condition that could interfere with the conduct of the study.
8\. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months.
9\. Treatment with bisphosphonates in the past 3 years.
10\. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use.
11\. Current or previous treatment with glucagon-like peptide (GLP-1) receptor agonists in the last one year.
12\. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
13\. Participants who plan on changing diet and/or exercise regime during trial participation.
14\. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
Serum 25-hydroxyvitamin D <20 ng/mL
Renal dysfunction (eGFR ≤50 ml/min)
15\. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic blood pressure greater than equal to 100mm Hg.
16\. Short Blessed Test score >10 or judged by the research staff as unable to follow the study protocol.
17\. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: SBD111 medical food

This group will receive SBD111 medical food capsules to be consumed over 18 months.

placebo comparator: Placebo

This group will receive placebo capsules to be consumed over 18 months.

Interventions

SBD111 medical food

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

Primary outcome measure

Lumbar spine BMD (g/cm2) [ Time Frame: Change over 18 months ]

Central Contacts and Locations

Central contacts

Shivani Sahni, PhD

617-971-5382 ShivaniSahni@hsl.harvard.edu

Evelyn O'Neill

617-697-6599 oneill@hsl.harvard.edu

Locations

Hebrew SeniorLife

Recruiting

Roslindale, Massachusetts, United States, 02131

Contacts

Kathryn Tasker

617-971-5351 KathyTasker@hsl.harvard.edu

More Information

Sponsor

Hebrew SeniorLife

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

Dietary probiotics
Dietary prebiotics
Gut microbiome
Older women
Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Hebrew SeniorLife on 2026-03-17.