Trials Sponsors Conditions Drugs Pricing

Conditions

Anxiety Autism Spectrum Disorders

Keywords

Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8
A 74-item survey with 14 scales. Report forms for specific age ranges assess the parent's perception of the child's GI function and/or symptoms during the last month on a 5-point scale from 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and transformed to a 0-100 scale so lower scores reflect worse GI dysfunction. Response choices are in Likert-scale format ranging from 0 to 4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Often, 4=Almost Always).
Baseline and Week 8 of Both the First and Second Intervention

Secondary Outcomes (6)

Change in Target Symptom Rating From Baseline at Week 8
Baseline and Week 8 of Both the First and Second Intervention
Change in Parent Anxiety Checklist--ASD From Baseline at Week 8
Baseline and Week 8 of Both the First and Second Intervention
Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8
Baseline and Week 8 of Both the First and Second Intervention
Change in Social Responsiveness Scale (SRS) From Baseline at Week 8
Baseline and Week 8 of Both the First and Second Intervention
Children's Sleep Habits Questionnaire (CSHQ) at Week 8
Week 8 of Both the First and Second Intervention
+1 more secondary outcomes

Study Arms (2)

Visbiome, Then Placebo

EXPERIMENTAL

The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.

Drug: Visbiome Extra Strength

Placebo, Then Visbiome

PLACEBO COMPARATOR

Placebo matched to probiotic.

Drug: Maltose (placebo)

Interventions

Maltose (placebo)Drug

Maltose with a trace amount of silicon dioxide

Also known as: Maltose with silicon dioxide

Placebo, Then Visbiome

Visbiome Extra StrengthDrug

It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety

Eligibility Criteria

Age3 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

have DSM-5 ASD on clinical evaluation by a doctoral-level diagnostician, confirmed by Autism Diagnostic Interview-Revised or Autism Diagnostic Observation Schedule;
be between 3 and 12 years old;

Sponsors & Collaborators

Autism Treatment Network
Research networkcollaborator
Autism Speaks
Othercollaborator
Ohio State University

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

MeSH Terms

Conditions

Autism Spectrum DisorderAnxiety Disorders

Interventions

MaltoseSilicon Dioxide

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydratesDisaccharidesOligosaccharidesSugars

Limitations and Caveats

Small sample. Crossover did not accurately anticipate the duration of carryover Crossover not the best design for this treatment.

Results Point of Contact

Title: Dr. L. Eugene Arnold, MD, MED. Professor Emeritus College of Medicine
Organization: Nisonger Center

Study Officials

Eugene Arnold, MD
Ohio State University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

13 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor Emeritus of Psychiatry

Study Record Dates

First Submitted

June 14, 2016

First Posted

September 16, 2016

Study Start

August 2016

Date type not reported

This date has not been verified as actual or estimated.

Probiotics for Quality of Life in Autism Spectrum Disorders

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Visbiome, Then Placebo

Placebo, Then Visbiome

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Visbiome, Then Placebo

Placebo, Then Visbiome

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations