Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder
Overview
- Phase
- Phase 1
- Intervention
- SB-121
- Conditions
- Autistic Disorder
- Sponsor
- Scioto Biosciences, Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Sephadex Microspheres in the Stool
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
SB-121 is being developed for use in the treatment of autistic disorder (AD).
This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study.
The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121 in subjects ages 15 to 45 years with AD.
Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in order to inform later stage trials.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject/parent (or authorized designee) has provided written informed consent for the study.
- •Subject is ≥15 and ≤45 years of age at the time of enrollment.
- •Diagnosis of autistic disorder (AD) as confirmed by the gold standard clinical interview using Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and administration of the Autism Diagnostic Observation Schedule-
- •Subject, if female and of childbearing potential, is not lactating or pregnant.
- •Subject, if female, is either not of childbearing potential or is practicing an acceptable effective method of birth control.
- •Subject is willing to comply with all study requirements (including the requirements for stool sampling and biobanking) and to return to the study facility for the follow-up evaluations, as required.
Exclusion Criteria
- •Subject has known allergy or significant adverse reaction to L reuteri, Sephadex®, maltose, or related compounds.
- •Subject has previously had GI surgery, intestinal obstruction, Clostridium difficile infection or diverticulitis.
- •Subject has travelled outside of the USA in the 30 days prior to screening.
- •Subject has had a diarrheal illness in 30 days prior to screening.
- •Subject currently has a fever or active/uncontrolled gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea, constipation, abdominal distention, abdominal pain/cramps, flatulence) or has had these within 14 days prior to screening. If the GI symptoms are stable, in the opinion of the investigator, the subject can be enrolled.
- •Subject has any immunological/autoimmune disorder including, but not limited to, systemic lupus erythematosis, rheumatoid arthritis, Sjögren's syndrome, inflammatory bowel disease, or immunoglobulin-deficiency disorder, that would increase the risk to the subject or interfere with the evaluation of SB-
- •Subject has a documented history of human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C
- •Subject has implanted prosthetic devices including prosthetic heart valves.
- •Subject has taken, or is taking, any of the following prohibited medications:
- •A proton pump inhibitor within 2 weeks prior to screening
Arms & Interventions
SB-121
One dose of SB-121 daily for 28 days according to the treatment group to which they are allocated. Administration: Oral
Intervention: SB-121
Placebo
One dose of placebo daily for 28 days according to the treatment group to which they are allocated. Administration: Oral
Intervention: Placebo
Outcomes
Primary Outcomes
Sephadex Microspheres in the Stool
Time Frame: Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 42 (period = 28 days and 14 days wash-out)
The presence of Sephadex microspheres in the stool was assessed. The number of participants with data available at each stage are presented.
Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation
Time Frame: Approximately 98 days
Adverse event of special interest (AESIs) and adverse events (AEs) leading to discontinuation from the study are presented. Treatment Period 1: 2 participants reported 4 events in the SB-121 group and 3 participant reported 6 events in the placebo group. Treatment Period 2: 1 participant reported 3 events in the SB-121 group and 1 participant reported 4 events in the placebo group.
Symptomatic Bacteremia With Positive L. Reuteri Identification
Time Frame: Approximately 98 days
The presence of symptomatic bacteremia with positive L. reuteri identification was assessed and none of the participants in either group showed any clinical features of suspected bacteremia in this study.
Secondary Outcomes
- Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α(Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out))
- Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin(Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 and 28 (period = 28 days and 14 days wash-out))
- Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin(Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out))
- Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin(Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out))
- Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP)(Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out))
- Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin(Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out))