HealthyNCT05206864
Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults
A study testing Medical Food: SBD111 in people with Healthy, run by Solarea Bio, Inc at 1 site in United States.
Trial summary
The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Medical Food: SBD111
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 5 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Stated availability throughout entire study period and willingness to fulfill all details of the protocol
- Age 18-70
- Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or placebo
- 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
- Normal cardiovascular parameters, systolic blood pressure ≤ 155 mm Hg, diastolic blood pressure ≤ 95 mm Hg)
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
- Received oral or parenteral antibiotics within 3 months of enrollment or prescribed antibiotics on day of enrollment.
- Major surgery or endoscopy within last 3 months.
- Subject is a smoker
Show all 26Show fewer
- Subject has a history of drug and/or alcohol abuse at the time of enrolment
- 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
- Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline visit (first dose of study drug)
- 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, neutrophil count <500/mm^3, or an anticipated drop in the neutrophil count to <500/mm3
- History of cancer excluding non-melanoma skin cancers or cancer more than 10 years ago
- History of collagen vascular disease
- Active TB
- Women only - pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test during screening or within 24 hours of first dose of study drug.
- Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
- WBCs < LLN or > ULN
- Neutrophils < 1500/µl (1.5 x109/L)
- Platelets < 100 x 10³/µl (100 x 109/L)
- Haemoglobin < 9.0 g/dl (90 g/L)
- GFR of > 40 mL/minute g. AST > 3 x upper limit of normal h. ALT > 3 x upper limit of normal i. Total Bilirubin > 1.5 x upper limit of normal
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, 02131
About this study
The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults.
- Conditions
- Healthy
- Being tested
- Medical Food: SBD111, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food: SBD111Other
One capsule administered twice daily with morning and evening meals for 28 days
PlaceboOther
One capsule administered twice daily with morning and evening meals for 28 days
| Study group | Role | What they receive |
|---|---|---|
| SBD111 | Experimental | Not described Receives: Other: Medical Food: SBD111 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by incidence of adverse advents
Occurrence of adverse events defined as a Grade II-IV toxicity (FDA's Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials, September 2007), that are possibly or probably related to administration of SBD111
Measured: day-0 to day-28
Secondary outcomes (1)
Gastrointestinal Tolerability as assessed by Gastrointestinal Tolerability Questionnaire
Occurrence of gastrointestinal intolerability symptoms defined as a Grade II-IV toxicity
Measured: day-0 to day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Sep 2021
- Primary completion5 Jan 2022
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solarea Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebrew SeniorLife
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206864
- Sponsor's protocol ID
- Pro00054643
- Status last verified
- Apr 2022
- First submitted
- 11 Jan 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults
- ClinicalTrials.gov ID
- NCT05206864
- Acronym / sponsor ID
- Pro00054643
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Solarea Bio, IncIndustry (pharma, biotech, devices)
- Collaborators
- Hebrew SeniorLife
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 25 Jan 2022 (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.
The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBD111 | Experimental | Other: Medical Food: SBD111 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- Stated availability throughout entire study period and willingness to fulfill all details of the protocol
- Age 18-70
- Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or placebo
- 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
- Received oral or parenteral antibiotics within 3 months of enrollment or prescribed antibiotics on day of enrollment.
- Major surgery 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 |
|---|---|---|
| Medical Food: SBD111One capsule administered twice daily with morning and evening meals for 28 days | Other | SBD111 |
| PlaceboOne capsule administered twice daily with morning and evening meals for 28 days | Other | Placebo |
Primary outcome
Safety as assessed by incidence of adverse advents
Time frame: day-0 to day-28
Occurrence of adverse events defined as a Grade II-IV toxicity (FDA's Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials, September 2007), that are possibly or probably related to administration of SBD111
1 secondary outcome
Gastrointestinal Tolerability as assessed by Gastrointestinal Tolerability Questionnaire
Time frame: day-0 to day-28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Food: SBD111 in people with Healthy, 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 7 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: finished, as of the sponsor's last update on 13 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety as assessed by incidence of adverse advents (time frame: day-0 to day-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2022.