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Sulforaphane for Autism

Phase 2

Waitlist Available

Led By Steven Buyske

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male gender

Age between 13-30 years

Must not have

Impaired renal function (serum creatinine > 1.2 mg/dl)

Current infection or treatment with antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests if sulforaphane, a compound from broccoli, can improve symptoms in males with autism. Sulforaphane boosts protective enzymes and helps manage stress and immune responses. The study aims to see improvements in social interaction, behavior, and communication. Sulforaphane, derived from broccoli sprouts, has shown potential benefits in previous trials for improving behavior and social responsiveness in individuals with autism spectrum disorder (ASD).

Who is the study for?

This trial is for males aged 13-30 with a diagnosis of autistic disorder in New Jersey. Participants must have a parent or guardian's consent and be able to complete all study visits. They should not have kidney, liver, thyroid issues, current infections, recent major surgery or chronic diseases like heart disease or diabetes.

What is being tested?

The trial is testing whether sulforaphane can improve core symptoms of autism. Sulforaphane is derived from vegetables like broccoli and will be given in controlled amounts compared to a placebo in a double-blind setup where neither the participants nor the researchers know who receives what treatment.

What are the potential side effects?

While specific side effects are not listed here, sulforaphane generally may cause gas or bowel irritation due to its source being vegetables like broccoli. Any additional side effects would be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am male.

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I am between 13 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is impaired with a creatinine level over 1.2 mg/dl.

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I am currently fighting an infection or taking antibiotics.

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My liver function is not more than twice the normal limit.

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I am female.

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I haven't had a major illness or surgery in the last 3 months.

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My thyroid function is not normal.

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I am willing and able to follow the study's schedule and treatments.

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I am either younger than 13 or older than 30.

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I have had a seizure in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2013 Phase 2 trial • 20 Patients • NCT01228084

35%

Flatulence

35%

Nausea

20%

Bloating

20%

Diarrhea

20%

Dyspepsia

15%

Gatrointestinal pain

100%

80%

60%

40%

20%

Study treatment Arm

Sulpforaphane

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SulforaphaneExperimental Treatment1 Intervention

About 30 subjects will be randomized into this arm, receiving pills with glucoraphanin rich broccoli seed powder containing active myrosinase resulting in sulforaphane once ingested Doses will be weight dependent with each pill resulting in \~ 50 µmol sulforaphane. Body weight Dose of sulforaphane 34 kg \~ 50 µmol 68 kg \~ 100 µmol 102 kg \~ 150 µmol

Group II: PlaceboPlacebo Group1 Intervention

About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulforaphane

Not yet FDA approved

0 / 11Eligibility criteria met