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

April 15, 2026 updated by: Solarea Bio, Inc

An Open-Label, Randomized, Parallel-Arm Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The human gut microbiome plays an important role in immune regulation, inflammatory signaling, and skeletal homeostasis. Alterations in the gut microbiome have been associated with multiple chronic conditions, and microbiome-directed interventions such as probiotics and prebiotics have been investigated for their effects on host metabolism and immune function. Preclinical and clinical findings suggest that microbiome-derived metabolites, including short-chain fatty acids, may help regulate pathways involved in bone remodeling and inflammatory balance.

SBD111 is a defined microbial assemblage composed of Lactobacillus brevis, Lactobacillus plantarum, Leuconostoc mesenteroides, and Pichia kudriavzevii in combination with oligofructose, dried blueberry powder, vitamin D3, and formulation excipients. The currently marketed formulation is administered as two capsules twice daily. A modified formulation has been developed to deliver the same total daily microbial load and strain composition in two capsules taken once daily. The modified formulation uses a larger capsule format and a reduced amount of dried blueberry powder while maintaining comparable microbial exposure.

In preclinical studies, SBD111 was associated with maintenance of bone mineral density and favorable effects on markers related to bone turnover and inflammatory signaling. Prior clinical evaluation in healthy adults and postmenopausal women indicated that SBD111 was safe and well tolerated. These data support further evaluation of formulation and dosing optimization.

The purpose of this study is to compare gastrointestinal exposure to SBD111 microbial strains following administration of the currently marketed twice-daily formulation and the modified once-daily formulation in healthy adults. The key objective is to determine whether once-daily administration of the modified formulation results in fecal abundance of SBD111 strains comparable to that observed with twice-daily administration of the currently marketed formulation.

Healthy adults aged 35 years and older will complete a 28-day study period. Baseline stool collection will occur before first product administration. Stool samples will be collected at baseline, Day 7, and Day 28 and analyzed using strain-specific quantitative polymerase chain reaction to assess fecal abundance of the four SBD111 strains. Gastrointestinal tolerability, adherence, adverse events, and participant-reported measures of sleep, cognitive function, and well-being will also be assessed during the study period.

Study product will be shipped to participants, and study procedures will be conducted remotely. Samples will be collected at home and returned by mail for laboratory analysis. Laboratory personnel performing sample analysis will remain blinded to treatment assignment. Participant confidentiality will be protected through coded identifiers and secure storage of study records.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:• Provide written informed consent.

  • 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.

Exclusion Criteria:

  • • 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.

    • History of cancer.

      a. Excluding non-melanoma skin cancers or cancer more than 10 years ago.

    • History of autoimmune disease and taking any immunosuppressant drugs.
    • Active tuberculosis.
    • Pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first administration of DMA.
    • Participants may be excluded if, in the investigator's opinion, there is evidence of cognitive impairment or dementia which is sufficient to interfere with informed consent or adherence to the study protocol. Four questions will be asked during the informed consent process to confirm participant's understanding and ability to comply. (See section 8.3)
    • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.
    • Bowel movement frequency less than one per 36-hour period.
    • If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SBD111 (current formulation)
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 (current formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken twice daily
Experimental: SBD111 (New formulation)
SBD111 (New formulation) contains the same daily amount probiotic microbes but is formulated to be taken once daily.
Combination product: SBD111 (new formulation)
SBD111 (new formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite fecal abundance of SBD111 microbial strains measured by strain-specific qPCR
Time Frame: From enrollment out to 28 days of consuming the product
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tolerability assessed by Gastrointestinal Tolerability Questionnaire (GITQ)
Time Frame: From enrollment through 28 days of product consumption
Gastrointestinal tolerability assessed using the Gastrointestinal Tolerability Questionnaire (GITQ), which records the presence and severity of gastrointestinal symptoms, at baseline, Day 7, and Day 28.
From enrollment through 28 days of product consumption
Fecal abundance of individual SBD111 microbial strains by strain-specific qPCR
Time Frame: From enrollment through 28 days of product consumption
Relative fecal abundance of each individual microbial strain contained in SBD111 -- Lactobacillus brevis, Lactobacillus plantarum, Leuconostoc mesenteroides, and Pichia kudriavzevii -- assessed separately by strain-specific qPCR and expressed as log10(copies/16S copies) at Days 7 and 28. Baseline-adjusted abundance for each strain will be compared between the modified (once-daily) and currently marketed (twice-daily) formulations using the same non-inferiority margin of 0.5 log units applied to the primary composite endpoint.
From enrollment through 28 days of product consumption
Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Gas and Bloating 13a score
Time Frame: From enrollment through 28 days of product consumption
Gastrointestinal symptoms assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a. PROMIS response-pattern scoring is preferred; for fully completed forms, raw summed scores range from 13 to 59. Higher scores indicate worse gas and bloating symptoms.
From enrollment through 28 days of product consumption
Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Constipation 9a score
Time Frame: From enrollment through 28 days of product consumption
Gastrointestinal symptoms assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a. For fully completed forms, raw summed scores range from 12 to 45. Higher scores indicate worse constipation symptoms.
From enrollment through 28 days of product consumption
Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Diarrhea 6a score
Time Frame: From enrollment through 28 days of product consumption
Gastrointestinal symptoms assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a. For fully completed forms, raw summed scores range from 8 to 30. Higher scores indicate worse diarrhea symptoms.
From enrollment through 28 days of product consumption

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b score
Time Frame: From enrollment through 28 days of product consumption
Sleep quality assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw summed scores range from 8 to 40. Higher scores indicate worse sleep disturbance.
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
Time Frame: From enrollment through 28 days of product consumption
Cognitive function assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Cognitive Function - Abilities Subset - Short Form 8a. Raw summed scores range from 8 to 40. Higher scores indicate better cognitive function.
From enrollment through 28 days of product consumption
General well-being assessed by World Health Organization-Five Well-Being Index raw score
Time Frame: From enrollment through 28 days of product consumption
General well-being assessed using the World Health Organization-Five Well-Being Index. Raw scores range from 0 to 25. Higher scores indicate better well-being.
From enrollment through 28 days of product consumption
Patient Global Impression of Change for gastrointestinal symptoms score
Time Frame: Day 28
Participant global impression of change in gastrointestinal symptoms assessed using the Patient Global Impression of Change question for gastrointestinal symptoms. Scores range from 1 to 7, where 1 indicates very much improved, 4 indicates no change, and 7 indicates very much worse. Lower scores indicate greater improvement.
Day 28
Patient Global Impression of Change for sleep quality score
Time Frame: Day 28
Participant global impression of change in sleep quality assessed using the Patient Global Impression of Change question for sleep. Scores range from 1 to 7, where 1 indicates very much improved, 4 indicates no change, and 7 indicates very much worse. Lower scores indicate greater improvement.
Day 28
Patient Global Impression of Change for cognitive function score
Time Frame: Day 28
Participant global impression of change in cognitive function assessed using the Patient Global Impression of Change question for cognitive function. Scores range from 1 to 7, where 1 indicates very much improved, 4 indicates no change, and 7 indicates very much worse. Lower scores indicate greater improvement.
Day 28
Patient Global Impression of Change for general well-being score
Time Frame: Day 28
Participant global impression of change in general well-being assessed using the Patient Global Impression of Change question for general well-being. Scores range from 1 to 7, where 1 indicates very much improved, 4 indicates no change, and 7 indicates very much worse. Lower scores indicate greater improvement.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solarea Bio, Inc

Investigators

  • Principal Investigator: Alicia E Ballok, PhD, Solaria Bio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00093649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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