Product Persistence in GI TractNCT06614166
Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults
A study testing SBD111 Probiotic Medical Food and SBD121 Probiotic Medical Food in people with Product Persistence in GI Tract and Kinetics, run by Solarea Bio, Inc at 1 site in United States.
Trial summary
This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Product Persistence in GI Tract, Kinetics, Rheumatoid Arthritis (RA)
- What is being tested?
- SBD111 Probiotic Medical Food and SBD121 Probiotic Medical Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2024to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent.
- Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
- Age 18-64 years.
- Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or SBD121.
- Willing to comply with protocol and report on compliance and side effects during study period.
- Body Mass Index between 18.5 and 35 kg/m2.
Who cannot join
- Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days.
- 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 3 months of enrollment or prescribed antibiotics on the day of enrollment.
- Major surgery on the intestines or endoscopy within last 3 months.
- Current smoker.
Show all 26Show fewer
- History of drug and/or alcohol abuse at the time of enrollment.
- Presence of any of the following:
- Abnormal vital signs or clinically significant systems abnormalities based on screening questionnaire.
- Indwelling catheter or implanted hardware/prosthetic device or feeding tube.
- Excluding joint replacements
- Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first dose 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.
- Excluding non-melanoma skin cancers or cancer more than 10 years ago.
- History of autoimmune disease and taking any immunosuppressant drugs.
- Active TB.
- Women only - pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first dose 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.
- 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 60 days prior to this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration.
Read the detailed description
This DMA persistence food trial provides critical complimentary data to the ongoing efficacy food trials of SBD111 and SBD121 medical foods. While the SBD111 and SBD121 medical food products have been tested in multiple preclinical studies, GLP-Toxicity studies in Rats, and ongoing safety and efficacy trials, no study has yet examined how quickly these DMAs become detectable/active in human stool samples or the rate they clear from human stool following treatment cessation. The data provided by this study could inform the interpretation efficacy trial data with regard to subject adherence.
Objectives The primary goal of this study is to evaluate the prevalence and persistence of SBD111 and SBD121 medical foods, two novel combinations of probiotics and prebiotic dietary fibers, over time in stool samples. We will determine the effect of these Defined Microbial Assemblages (DMAs) on fecal microbiota composition and functional potential, as well as the duration of SBD111 and SBD121 product persistence in the gastrointestinal tract. DMAs will be administered for 7 days, and stool samples will be collected during DMA administration and up to 28 days post DMA cessation for microbial DNA extraction. Fecal microbial DNA will be subjected to qPCR and high throughput shotgun sequencing to determine the presence and amount of DMA microbes that are present before, during, and after DMA administration. We will also use the resulting shotgun sequencing data to determine whether any taxonomic shifts or functional changes occur in response to DMA administration and/or cessation. Finally, as an exploratory measure, we will attempt to isolate live DMA microbes from participants' fecal samples using microbiological techniques.
- Being tested
- SBD111 Probiotic Medical Food, SBD121 Probiotic Medical Food
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBD111 Probiotic Medical FoodOther
Medical food comprised of probiotics and prebiotic fibers
SBD121 Probiotic Medical FoodOther
Probiotic medical food comprised of three lactic acid bacteria and one bacillus
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Medical Food SBD111 | Experimental | Probiotic comprised of three lactic acid bacteria and one yeast Receives: Other: SBD111 Probiotic Medical Food |
| Synbiotic Medical Food SBD121 | Experimental | Probiotic comprised of three lactic acid bacteria and one bacillus Receives: Other: SBD121 Probiotic Medical Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of SBD111 and SBD121 microbes in fecal samples
DNA isolated from fecal swabs will be used to determine the persistence of SBD111 and SBD121 microbes in stool samples up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults.
Measured: 5 weeks
Secondary outcomes (1)
Microbial Community Structure Changes
Using metagenomic sequencing, we will assess microbial community structural and functional changes that occur during and up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults. This will be done via sequence assessment of microbiota taxonomies and functional genes.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start14 Jun 2024
- Primary completion23 May 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Product Persistence in GI TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solarea Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia E Ballok, PhD, Principal investigator, Solarea Bio, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614166
- Sponsor's protocol ID
- Pro00078728
- Status last verified
- Apr 2025
- First submitted
- 19 Sep 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
Easson DD Jr, Murphy VA, Ballok AE, Soto-Giron MJ, Miller KJ, Charbonneau MR, Schott EM, Greene T, Rodricks J, Toledo GV. Food safety assessment and 28-day toxicity study of the synbiotic medical food consortium SBD121. Food Chem Toxicol. 2024 Sep;191:114839. doi: 10.1016/j.fct.2024.114839. Epub 2024 Jun 26.
PubMed 38942165Easson 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.
PubMed 35948142Lawenius L, Gustafsson KL, Wu J, Nilsson KH, Moverare-Skrtic S, Schott EM, Soto-Giron MJ, Toledo GV, Sjogren K, Ohlsson C. Development of a synbiotic that protects against ovariectomy-induced trabecular bone loss. Am J Physiol Endocrinol Metab. 2022 Apr 1;322(4):E344-E354. doi: 10.1152/ajpendo.00366.2021. Epub 2022 Feb 14.
PubMed 35156423Miller 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.
PubMed 41672081
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults
- ClinicalTrials.gov ID
- NCT06614166
- Acronym / sponsor ID
- Pro00078728
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Solarea Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 23 May 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration.
Detailed description
This DMA persistence food trial provides critical complimentary data to the ongoing efficacy food trials of SBD111 and SBD121 medical foods. While the SBD111 and SBD121 medical food products have been tested in multiple preclinical studies, GLP-Toxicity studies in Rats, and ongoing safety and efficacy trials, no study has yet examined how quickly these DMAs become detectable/active in human stool samples or the rate they clear from human stool following treatment cessation. The data provided by this study could inform the interpretation efficacy trial data with regard to subject adherence.
Objectives The primary goal of this study is to evaluate the prevalence and persistence of SBD111 and SBD121 medical foods, two novel combinations of probiotics and prebiotic dietary fibers, over time in stool samples. We will determine the effect of these Defined Microbial Assemblages (DMAs) on fecal microbiota composition and functional potential, as well as the duration of SBD111 and SBD121 product persistence in the gastrointestinal tract. DMAs will be administered for 7 days, and stool samples will be collected during DMA administration and up to 28 days post DMA cessation for microbial DNA extraction. Fecal microbial DNA will be subjected to qPCR and high throughput shotgun sequencing to determine the presence and amount of DMA microbes that are present before, during, and after DMA administration. We will also use the resulting shotgun sequencing data to determine whether any taxonomic shifts or functional changes occur in response to DMA administration and/or cessation. Finally, as an exploratory measure, we will attempt to isolate live DMA microbes from participants' fecal samples using microbiological techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Medical Food SBD111 | Experimental | Other: SBD111 Probiotic Medical FoodProbiotic comprised of three lactic acid bacteria and one yeast |
| Synbiotic Medical Food SBD121 | Experimental | Other: SBD121 Probiotic Medical FoodProbiotic comprised of three lactic acid bacteria and one bacillus |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provide written informed consent.
- Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
- Age 18-64 years.
- Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or SBD121.
- Willing to comply with protocol and report on compliance and side effects during study period.
Key exclusion criteria (26 listed)
- Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days.
- 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 3 months of enrollment or prescribed antibiotics on the day of enrollment.
- Major surgery on the intestines or endoscopy within last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBD111 Probiotic Medical FoodMedical food comprised of probiotics and prebiotic fibers | Other | Synbiotic Medical Food SBD111 |
| SBD121 Probiotic Medical FoodProbiotic medical food comprised of three lactic acid bacteria and one bacillus | Other | Synbiotic Medical Food SBD121 |
Primary outcome
Persistence of SBD111 and SBD121 microbes in fecal samples
Time frame: 5 weeks
DNA isolated from fecal swabs will be used to determine the persistence of SBD111 and SBD121 microbes in stool samples up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults.
1 secondary outcome
Microbial Community Structure Changes
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 38942165Easson DD Jr, Murphy VA, Ballok AE, Soto-Giron MJ, Miller KJ, Charbonneau MR, Schott EM, Greene T, Rodricks J, Toledo GV. Food safety assessment and 28-day toxicity study of the synbiotic medical food consortium SBD121. Food Chem Toxicol. 2024 Sep;191:114839. doi: 10.1016/j.fct.2024.114839. Epub 2024 Jun 26.
- Background: PubMed 35948142Easson 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.
- Background: PubMed 35156423Lawenius L, Gustafsson KL, Wu J, Nilsson KH, Moverare-Skrtic S, Schott EM, Soto-Giron MJ, Toledo GV, Sjogren K, Ohlsson C. Development of a synbiotic that protects against ovariectomy-induced trabecular bone loss. Am J Physiol Endocrinol Metab. 2022 Apr 1;322(4):E344-E354. doi: 10.1152/ajpendo.00366.2021. Epub 2022 Feb 14.
- Derived from this study: PubMed 41672081Miller 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.
- Individual participant dataSharing planned: No. no plan
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia E Ballok, PhD principal investigator
Solarea Bio, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBD111 Probiotic Medical Food and SBD121 Probiotic Medical Food in people with Product Persistence in GI Tract and Kinetics, run by Solarea Bio, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of SBD111 and SBD121 microbes in fecal samples (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614166, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.