Probiotics for Quality of Life in Autism Spectrum Disorders

NCT02903030 | Completed Early Phase 1 Results

• 1 other identifier: 2016H0174
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.

Conditions

Autism Spectrum Disorders; Anxiety

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

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 Strength DRUG

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

Visbiome, Then Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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;
• have \>2 mo. abdominal pain, constipation, diarrhea, and/or vomiting, with an item-mean score \>2 on at least one scale of the GI module of the PedsQL scale;
• have clinical anxiety symptoms with an item mean of \>1.0 (0-3 scale) on the new Autism Anxiety Scale.
• Participants will be recruited from minority, poor, inner city, or rural populations.

You may not qualify if:

• Antibiotics in 2 months prior to enrolling;
• Prior bowel surgery;
• Chronic serious medical condition (e.g., diabetes);
• Weight or height \< 3rd %ile for age;
• Chronic anti-inflammatory use within 2 months prior to enrolling;
• History of inflammatory bowel disease, Celiac disease, or eosinophilic disorders (e.g., eosinophilic esophagitis);
• Already taking probiotics within the previous 6 months.

Sponsors & Collaborators

• Ohio State University: lead
• Autism Treatment Network: collaborator
• Autism Speaks: collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Interventions

Maltose; Silicon Dioxide

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars; Minerals; Inorganic Chemicals; Oxides; Oxygen Compounds; Silicon Compounds

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

l.arnold@osumc.edu

614-685-6701

Study Officials

• Eugene Arnold, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (1)