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| Name | Class |
|---|---|
| Hebrew SeniorLife | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBD111 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Food: SBD111 | Other | One capsule administered twice daily with morning and evening meals for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day-0 to day-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Tolerability as assessed by Gastrointestinal Tolerability Questionnaire | Occurrence of gastrointestinal intolerability symptoms defined as a Grade II-IV toxicity | day-0 to day-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Composition and function of the gut microbiome and presence of SBD111 in stool specimens by shotgun metagenomic sequencing | Day-0 to Day-28 and Day-56 (washout) |
Inclusion Criteria:
Exclusion Criteria:
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
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):
f. 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinda and Arthur Marcus Institute for Aging Research | Boston | Massachusetts | 02131 | United States |
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| Placebo | Other | One capsule administered twice daily with morning and evening meals for 28 days |
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