Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults

NCT05206864 | Completed

• 1 other identifier: Pro00054643
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Gastrointestinal Tolerability as assessed by Gastrointestinal Tolerability Questionnaire

  day-0 to day-28

Other Outcomes (1)

• 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)

Study Arms (2)

SBD111

EXPERIMENTAL

Other: Medical Food: SBD111

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Medical Food: SBD111 OTHER

One capsule administered twice daily with morning and evening meals for 28 days

SBD111

Placebo OTHER

One capsule administered twice daily with morning and evening meals for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Solarea Bio, Inc: lead
• Hebrew SeniorLife: collaborator

Study Sites (1)

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, 02131, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: September 1, 2021
• Primary Completion: January 5, 2022
• Study Completion: February 5, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

US (1)