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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944901
• Other study ID #: SBI-SB121-20-01
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2021
• Est. completion date: March 3, 2022

Study information

• Verified date: September 2023
• Source: Scioto Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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-2.

• 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-121.

• 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:

1. A proton pump inhibitor within 2 weeks prior to screening

2. Use of supplemental probiotics within 2 weeks prior to screening except for yogurt

3. Current use of immunosuppressive medications, including corticosteroids

4. Treatment with monoclonal antibodies within 4 weeks prior to screening

5. Systemic antibiotics within 2 weeks prior to screening

• Subject has diabetes mellitus or is prediabetic.

• Subject has received any IP (or investigational device) within 30 days prior to screening.

• Subject has any of the following laboratory test results at Screening:

1. An absolute neutrophil count of <1.5 × 10^9/L

2. alanine aminotransferase or aspartate aminotransferase >1.5 × upper limit normal (ULN), total bilirubin >1.5 × ULN (subjects with known Gilbert's Syndrome can be included)

3. serum creatinine >1.5 × ULN

4. any other abnormal laboratory test that is clinically significant in the judgment of the investigator.

• Subject has an unstable medical condition or is otherwise considered unreliable or incapable, in the opinion of the investigator, of complying with the requirements of the protocol.

• Subject tests positive for drugs of abuse in a urine drug screen at screening.

• Subject has a history of alcohol abuse.

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Drug:
• SB-121
SB-121 is a formulation of L. reuteri
• Placebo
Placebo oral formulation

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Scioto Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation	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.	Approximately 98 days
Primary	Sephadex Microspheres in the Stool	The presence of Sephadex microspheres in the stool was assessed.; The number of participants with data available at each stage are presented.	Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 42 (period = 28 days and 14 days wash-out)
Primary	Symptomatic Bacteremia With Positive L. Reuteri Identification	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.	Approximately 98 days
Secondary	Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-a	Mean (standard deviation) percent changes from baseline in tumor necrosis factor-a	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)
Secondary	Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP)	Mean (standard deviation) percent change from baseline in 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)
Secondary	Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin	Mean (standard deviation) percent change from baseline in stool biomarkers, fecal calprotectin.; The number of participants with data available are presented.	Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out)
Secondary	Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin	Mean (standard deviation) percent change from baseline in stool biomarkers, fecal lactoferrin.; The number of participants with data available are presented.	Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out)
Secondary	Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin	The mean (standard deviation) percent changes from baseline in 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)
Secondary	Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin	Mean (standard deviation) percent changes from baseline in plasma vasopressin levels	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)