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Probiotic

Flore for Autism Spectrum Disorder

Phase < 1
Waitlist Available
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children and adults ages 2.5-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in score between baseline and 3 months
Awards & highlights

Study Summary

This trial looks at whether a probiotic can help improve symptoms in children and adults with autism, as well as any gastrointestinal issues they may have.

Who is the study for?
This trial is for children and adults aged 2.5-75 years who have been diagnosed with Autism Spectrum Disorder (ASD). Participants must be new clients of Sun Genomics, not having started treatment yet, and their ASD diagnosis will be confirmed by an evaluation. They should not have had any medication or therapy changes in the last two months nor plan to change them during the first three months of the study.Check my eligibility
What is being tested?
The study is testing a customized probiotic called Flore on individuals with autism to see if it can improve both autism-related symptoms and gastrointestinal issues. The participants' responses to this probiotic therapy are being closely monitored.See study design
What are the potential side effects?
While specific side effects are not listed, probiotics typically may cause digestive discomfort initially such as gas or bloating; however, they're generally considered safe. Any unexpected reactions would be documented throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between the ages of 2.5 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in score between baseline and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in score between baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parent Global Impressions of Autism
Secondary outcome measures
Gastrointestinal Symptom Rating Scale
Social Responsiveness Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Each participant receives a customized probiotic based on the results of the test of their microbiota

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,164 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
383 Patients Enrolled for Autism Spectrum Disorder
Sun GenomicsUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Flore (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04655326 — Phase < 1
Autism Spectrum Disorder Research Study Groups: Treatment Group
Autism Spectrum Disorder Clinical Trial 2023: Flore Highlights & Side Effects. Trial Name: NCT04655326 — Phase < 1
Flore (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04655326 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this investigation?

"As per information on clinicaltrials.gov, this trial is still looking for participants. It was initially uploaded on October 15th 2020 and the data synopsis underwent its latest update on December 29th 2021."

Answered by AI

What is the enrolment capacity of this trial?

"That is correct. According to the datasheet hosted on clinicaltrials.gov, recruitment for this trial commenced on October 15th 2020 and was recently updated at the end of December 2021 which confirms that it's currently searching for 1000 participants from a single medical site."

Answered by AI

Is the age limit for this experiment open to those under fifty-five years of age?

"According to the set criteria, individuals aged between 30 months and 75 years old can apply for this trial. Meanwhile, there are 229 trials that cater to those under 18 while 42 studies are specially tailored for people over 65."

Answered by AI

Which individuals meet the criteria to participate in this research?

"This clinical trial is currently accepting 1000 individuals with autism spectrum disorder ranging from 2.5 to 75 years old. To qualify, applicants must be a new client of Sun Genomics, possess an ASD diagnosis validated by the Social Responsiveness Scale (SRS-2) administered by ASU staff, and fall within the specified age range."

Answered by AI

Who else is applying?

What state do they live in?
New York
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
James B Adams 2020. "Probiotic Therapy for Children and Adults With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655326.
All > Asd > Autism
~23 spots leftby Aug 2024
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