Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorSolarea Bio, Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
SBD111(current formulation)
Combination productSBD111 (current formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken twice daily
SBD111 (new formulation)
Combination productSBD111 (new formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken once daily
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: SBD111 (current formulation)Active comparator 1 intervention
Group B: SBD111 (New formulation)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment out to 28 days of consuming the productSecondary outcomes
1
Gastrointestinal tolerability assessed by Gastrointestinal Tolerability Questionnaire (GITQ)
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.
Time frame
From enrollment through 28 days of product consumption2
Fecal abundance of individual SBD111 microbial strains by strain-specific qPCR
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.
Time frame
From enrollment through 28 days of product consumption3
Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Gas and Bloating 13a score
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.
Time frame
From enrollment through 28 days of product consumption4
Gastrointestinal symptoms assessed by Patient-Reported Outcomes Measurement Information System Gastrointestinal Constipation 9a score
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.
Time frame
From enrollment through 28 days of product consumptionOther outcomes
1
Sleep quality assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b score
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.
Time frame
From enrollment through 28 days of product consumption2
Cognitive function assessed by Patient-Reported Outcomes Measurement Information System Cognitive Function - Abilities Subset Short Form 8a score
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.
Time frame
From enrollment through 28 days of product consumption3
General well-being assessed by World Health Organization-Five Well-Being Index raw score
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.
Time frame
From enrollment through 28 days of product consumption4
Patient Global Impression of Change for gastrointestinal symptoms score
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.
Time frame
Day 28Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: