Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults

NCT07538167 | Not Yet Recruiting

• 1 other identifier: Pro00093649
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation. SBD111 is a food made of probiotic microbes (bacteria and yeast) and prebiotic dietary fibers (a form of fiber obtained from diet). SBD111 is a medical food used for the dietary management of postmenopausal bone loss.SBD111 was previously found to be safe and well tolerated in a human clinical safety study and a clinical efficacy study. Study participation will include a screening virtual visit, periodic remote questionnaires and check-in calls, and three at-home stool swab sample collections. Eligible participants will be assigned to one of two SBD111 study groups evaluating different formulations and dosing schedules. Each day for a 28-day period, they will take (i) two capsules once daily or (ii) two capsules twice daily (morning and evening), depending on the study group assigned. Investigators will collect demographic information and will ask questions related to dietary intake, bowel habits, and health history. Upon enrollment into the study, participants will receive six at-home stool sample collection kits, two each for baseline, Week 1, and Week 4 analysis. Samples will be collected at home and mailed to a Sōlaria Biō for analysis of the bacterial community that lives in the intestine (the gut microbiome). During the study, participants will also be asked to complete brief questionnaires related to gastrointestinal symptoms, cognitive function, well-being, and sleep. On days 7 and 28 of the study, they will be asked to complete a brief adherence questionnaire and discuss any adverse (negative) events. All participants will receive compensation in the form of gift cards for completing study procedures and returning stool samples. Participants will receive a $50.00 gift card after completing the Week 1 study procedures and after receipt of the mailed baseline and Day 7 stool swab samples. Participants will receive a $150.00 gift card after completing the Week 4 study procedures and after receipt of the mailed Week 4 stool swab sample.

Conditions

Osteopenia; Osteoporosis; Menopause Related Conditions; Probiotic Intervention; Synbiotics

Keywords

Probiotic; Synbiotic; Bone Loss; Osteopenia; Osteoporosis; Fully Remote

Outcome Measures

Primary Outcomes (1)

• Composite fecal abundance of SBD111 microbial strains measured by strain-specific qPCR

  Composite fecal abundance of the four SBD111 microbial strains (Lactobacillus brevis, Lactobacillus plantarum, Leuconostoc mesenteroides, and Pichia kudriavzevii) assessed by strain-specific qPCR and expressed as log10(copies/16S copies). The composite endpoint is the mean of the four log10-transformed strain-specific values. Non-inferiority of the modified formulation vs. the currently marketed formulation will be declared if the upper bound of the 95% CI for the between-group difference does not exceed 0.5 log units.

  From enrollment out to 28 days of consuming the product

Secondary Outcomes (5)

• Gastrointestinal tolerability assessed by Gastrointestinal Tolerability Questionnaire (GITQ)

  From enrollment through 28 days of product consumption

• Fecal abundance of individual SBD111 microbial strains by strain-specific qPCR

  From enrollment through 28 days of product consumption

• Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Gas and Bloating 13a score

  From enrollment through 28 days of product consumption

• Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Constipation 9a score

  From enrollment through 28 days of product consumption

• Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Diarrhea 6a score

  From enrollment through 28 days of product consumption

Other Outcomes (7)

• Sleep quality assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b score

  From enrollment through 28 days of product consumption

• Cognitive function assessed by Patient-Reported Outcomes Measurement Information System Cognitive Function - Abilities Subset Short Form 8a score

  From enrollment through 28 days of product consumption

• General well-being assessed by World Health Organization-Five Well-Being Index raw score

  From enrollment through 28 days of product consumption

Study Arms (2)

SBD111 (current formulation)

ACTIVE COMPARATOR

SBD111 (Bondia), is a commercial medical food for dietary management of postmenopausal bone loss. This product is taken twice daily.

Combination Product: SBD111(current formulation)

SBD111 (New formulation)

EXPERIMENTAL

SBD111 (New formulation) contains the same daily amount probiotic microbes but is formulated to be taken once daily.

Combination Product: SBD111 (new formulation)

Interventions

SBD111(current formulation) COMBINATION_PRODUCT

SBD111 (current formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken twice daily

SBD111 (current formulation)

SBD111 (new formulation) COMBINATION_PRODUCT

SBD111 (new formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken once daily

SBD111 (New formulation)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
• Age 35 years or older.
• Be in general good health as determined by a screening evaluation within 30 days of the first administration of SBD111 medical foods.
• Willing to comply with protocol and report on compliance and side effects during study period.
• Body Mass Index between 18.5 and 40kg/m2.

You may not qualify if:

• Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days. If participant is willing to stop taking probiotic or prebiotic supplement for 30-days, they can be re-screened for eligibility and enrollment after consent.
• Unwilling to avoid probiotics/prebiotics supplements for the duration of the study.
• Known or suspected allergies to probiotics, maltodextrin, or berries.
• Received oral or parenteral antibiotics within 30 days of enrollment or prescribed antibiotics on the day of enrollment.
• Major surgery on the intestines or endoscopy within last 3 months.
• History of drug and/or alcohol abuse at the time of enrollment.
• Presence of any of the following based on participant reported health history:
• Clinically significant systems abnormalities based on screening questionnaire.
• Indwelling catheter or feeding tube.
• Febrile illness (oral temperature \>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first administration of study article).
• Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease.
• History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.
• Underlying structural heart disease or previous history of endocarditis or valve replacement.
• Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy.
• History of Celiac disease.

Sponsors & Collaborators

• Solarea Bio, Inc: lead

Related Publications (5)

• Miller KJ, Wolff IM, Montes de Oca Valeriano LA, Soto-Giron MJ, Jangi S, Schott EM, Charbonneau MR, Ballok AE, Toledo GV. Targeted detection of microbes in synbiotic medical foods SBD111 and SBD121 to evaluate gut persistence: a randomised, open label trial. Benef Microbes. 2026 Feb 9:1-13. doi: 10.1163/18762891-bja00109. Online ahead of print.

  PMID: 41672081 BACKGROUND

• Green RS, Roy T, Morales DD, Morrow C, Neilson R, Schott EM, Charbonneau MR, Ballok AE, Motyl KJ, Toledo GV. A synbiotic medical food improves gut barrier function, reduces immune responses, and inhibits osteoclast activity in models of postmenopausal bone loss aligned with clinical outcomes. J Funct Foods. 2025 Dec;135:107114. doi: 10.1016/j.jff.2025.107114. Epub 2025 Nov 28.

  PMID: 41584438 BACKGROUND

• Sahni S, Schott EM, Carroll D, Soto-Giron MJ, Corbett S, Toledo GV, Kiel DP. Randomized clinical trial to test the safety and tolerability of SBD111, an optimized synbiotic medical food combination designed for the dietary management of the metabolic processes underlying osteopenia and osteoporosis. J Microbiol Exp. 2023;11(1):1-11. doi: 10.15406/jmen.2023.11.00379. Epub 2023 Jan 25.

  PMID: 39687223 BACKGROUND

• Easson DD Jr, Murphy VA, Ballok AE, Soto-Giron MJ, Schott EM, Rodricks J, Toledo GV. Food safety assessment and toxicity study of the synbiotic consortium SBD111. Food Chem Toxicol. 2022 Oct;168:113329. doi: 10.1016/j.fct.2022.113329. Epub 2022 Aug 7.

  PMID: 35948142 BACKGROUND

• Schott EM, Charbonneau MR, Kiel DP, Bukata S, Zuscik MJ, Rosen C, Ballok A, Toledo GV, Steels E, Huntress H, Rao A, Ebelt P, Travison TG, Soto-Giron MJ, Wolff I, Easson DD Jr, Engelke K, Vitetta L. A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of the synbiotic medical food, SBD111, for the clinical dietary management of bone loss in menopausal women. Osteoporos Int. 2025 Oct;36(10):2019-2030. doi: 10.1007/s00198-025-07650-7. Epub 2025 Aug 15.

  PMID: 40815418 BACKGROUND

Related Links

• Product Website
• Link to Prescreen Survey

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alicia E Ballok, PhD

  Solaria Bio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia E Ballok, PhD

CONTACT

‪508-625-0530; aballok@solaria.bio

Mark Charbonneau, PhD

CONTACT

clinicaltrials@solaria.bio‬

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While this interventional trial is open label, the researchers performing the product abundance analyses will be blinded to the treatment groups.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04