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Probiotic

SB-121 for Autism

Phase 1
Waitlist Available
Led By Craig Erickson, MD
Research Sponsored by Scioto Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period 1: days 1 (pre-dose), 28 and 35; period 2: days 28 and 42 (period = 28 days and 14 days wash-out)

Summary

This trial tests a new treatment called SB-121 for people aged 15 to 45 with autism. It aims to see if the treatment is safe and how it affects autism symptoms and biological markers.

Eligible Conditions
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 1: days 1 (pre-dose), 28 and 35; period 2: days 28 and 42 (period = 28 days and 14 days wash-out)
This trial's timeline: 3 weeks for screening, Varies for treatment, and period 1: days 1 (pre-dose), 28 and 35; period 2: days 28 and 42 (period = 28 days and 14 days wash-out) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation
Sephadex Microspheres in the Stool
Symptomatic Bacteremia With Positive L. Reuteri Identification
Secondary study objectives
Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin
Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin
Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP)
+3 more

Side effects data

From 2022 Phase 1 trial • 15 Patients • NCT04944901
13%
Diarrhoea
13%
Sinusitis
13%
Cough
7%
Leukocytosis
7%
Abdominal pain upper
7%
Nausea
7%
Fatigue
7%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
SB-121
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SB-121Experimental Treatment1 Intervention
One dose of SB-121 daily for 28 days according to the treatment group to which they are allocated. Administration: Oral
Group II: PlaceboPlacebo Group1 Intervention
One dose of placebo daily for 28 days according to the treatment group to which they are allocated. Administration: Oral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SB-121
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Scioto Biosciences, Inc.Lead Sponsor
Craig Erickson, MDPrincipal InvestigatorUniversity of Cincinnati
5 Previous Clinical Trials
148 Total Patients Enrolled
~4 spots leftby Nov 2025
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