Autistic DisorderPhase 1NCT04944901

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

A Phase 1 study testing SB-121 in people with Autistic Disorder, run by Scioto Biosciences, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 15 to 45 years
Conditions the study is for: Autistic Disorder
What is being tested?: SB-121
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 2 Aug 2021to 3 Mar 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Show all 24Show fewer

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
Use of supplemental probiotics within 2 weeks prior to screening except for yogurt
Current use of immunosuppressive medications, including corticosteroids
Treatment with monoclonal antibodies within 4 weeks prior to screening
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:
An absolute neutrophil count of <1.5 × 10^9/L
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)
serum creatinine >1.5 × ULN
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

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

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.

Conditions: Autistic Disorder
Being tested: SB-121, Placebo
Keywords: Lactobacillus reuteri, autistic disorder, microbiome
Medical subject headings: Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04944901
Study group	Role	What they receive
SB-121	Experimental	One dose of SB-121 daily for 28 days according to the treatment group to which they are allocated. Administration: Oral Receives: Drug: SB-121
Placebo	Placebo comparator	One dose of placebo daily for 28 days according to the treatment group to which they are allocated. Administration: Oral Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Approximately 98 days
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.
Measured: Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 42 (period = 28 days and 14 days wash-out)
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.
Measured: Approximately 98 days

Secondary outcomes (6)

Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α
Mean (standard deviation) percent changes from baseline in tumor necrosis factor-α
Measured: 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: Serum High-sensitivity C-reactive Protein (Hs-CRP)
Mean (standard deviation) percent change from baseline in serum high-sensitivity C-reactive protein (hs-CRP)
Measured: 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
Mean (standard deviation) percent change from baseline in stool biomarkers, fecal calprotectin.
The number of participants with data available are presented.
Measured: 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: 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.
Measured: 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: Plasma Oxytocin
The mean (standard deviation) percent changes from baseline in plasma oxytocin.
Measured: 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
Mean (standard deviation) percent changes from baseline in plasma vasopressin levels
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 20213 Mar 2022

First posted30 Jun 2021
Study start2 Aug 2021
Primary completion3 Mar 2022
Study completion3 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autistic DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04944901
Sponsor's protocol ID: SBI-SB121-20-01
Status last verified: Sep 2023
First submitted: 21 Jun 2021
Last updated: 25 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Schmitt LM, Smith EG, Pedapati EV, Horn PS, Will M, Lamy M, Barber L, Trebley J, Meyer K, Heiman M, West KHJ, Hughes P, Ahuja S, Erickson CA. Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder. Sci Rep. 2023 Mar 30;13(1):5192. doi: 10.1038/s41598-023-30909-0.
PubMed 36997569

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04944901
Acronym / sponsor ID: SBI-SB121-20-01
Conditions: Autistic Disorder
Keywords: Lactobacillus reuteri, autistic disorder, microbiome
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Scioto Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 2 Aug 2021 (actual)
Primary completion: 3 Mar 2022 (actual)
Study completion: 3 Mar 2022 (actual)
First posted: 30 Jun 2021 (actual)
Results: Posted 25 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
SB-121	Experimental	Drug: SB-121One dose of SB-121 daily for 28 days according to the treatment group to which they are allocated. Administration: Oral
Placebo	Placebo comparator	Drug: PlaceboOne dose of placebo daily for 28 days according to the treatment group to which they are allocated. Administration: Oral

Who may qualify

Ages: 15 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SB-121SB-121 is a formulation of L. reuteri	Drug	SB-121
PlaceboPlacebo oral formulation	Drug	Placebo

Primary outcome

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.
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.
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.

6 secondary outcomes

Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α
Time frame: 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: Serum High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: 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
Time frame: 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: Stool Biomarkers, Fecal Lactoferrin
Time frame: 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: Plasma Oxytocin
Time frame: 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
Time frame: 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)

Results and safety

Results posted to the registry on 25 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (SB-121 - Placebo)	7	7
Group 2 (Placebo - SB-121)	8	8

Primary outcome: Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation

Time frame: Approximately 98 days. Number. Unit: adverse events

Measure	SB-121 n = 15	Placebo n = 15
Treatment Period 1 : Adverse events leading to discontinuation	0	0
Treatment Period 1 : Diarrhoea (AESI)	1	2
Treatment Period 1 : Abdominal pain (AESI)	0	2
Treatment Period 1 : Abdominal pain upper (AESI)	2	0
Treatment Period 1 : Nausea (AESI)	1	0
Treatment Period 1 : Vomiting (AESI)	0	2
Treatment Period 2 : Adverse events leading to discontinuation	0	0
Treatment Period 2 : Diarrhoea (AESI)	3	3

Population analysed: Safety Population

Primary outcome: 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). Count of participants. Unit: Participants

Measure	SB-121 n = 15	Placebo n = 15
Period 1 Day 1: Sephadex Positive	2	1
Period 1 Day 1: Sephadex Negative	1	2
Period 1 Day 28: Sephadex Positive	6	5
Period 1 Day 28: Sephadex Negative	0	0
Period 1 Day 35/Washout: Sephadex Positive	2	2
Period 1 Day 35/Washout: Sephadex Negative	1	2
Period 2 Day 28/End of treatment: Sephadex Positive	4	1
Period 2 Day 28/End of treatment: Sephadex Negative	0	0

Population analysed: Intent-to-Treat Population

Primary outcome: Symptomatic Bacteremia With Positive L. Reuteri Identification

Time frame: Approximately 98 days. Count of participants. Unit: Participants

Measure	SB-121 n = 15	Placebo n = 15
Value	0	0

Population analysed: Intent-to-Treat Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any time after informed consent was obtained until 14 days after study treatment, approximately 14 weeks (112 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB-121	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15
Placebo	0 of 15 (0%)	9 of 15 (60%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36997569Schmitt LM, Smith EG, Pedapati EV, Horn PS, Will M, Lamy M, Barber L, Trebley J, Meyer K, Heiman M, West KHJ, Hughes P, Ahuja S, Erickson CA. Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder. Sci Rep. 2023 Mar 30;13(1):5192. doi: 10.1038/s41598-023-30909-0.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig Erickson, MD principal investigator

University of Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB-121 in people with Autistic Disorder, run by Scioto Biosciences, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation (time frame: Approximately 98 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944901, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.