Early Phase 1
N=13
Probiotics for Quality of Life in Autism Spectrum Disorders
Autism Spectrum Disorders · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02903030 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8 — 17.97; 7.98 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Maltose (placebo) (Drug); Visbiome Extra Strength (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8 |
17.97; 7.98 | — |
| SECONDARY Change in Target Symptom Rating From Baseline at Week 8 |
-2.10; -0.60 | — |
| SECONDARY Change in Parent Anxiety Checklist--ASD From Baseline at Week 8 |
-6.20; -4.10 | — |
| SECONDARY Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8 |
-1.80; -3.50; -2.60; -2.50; -1.20; -1.80 | — |
| SECONDARY Change in Social Responsiveness Scale (SRS) From Baseline at Week 8 |
-4.70; -1.70 | — |
| SECONDARY Children's Sleep Habits Questionnaire (CSHQ) at Week 8 |
42.80; 43.44 | — |
| SECONDARY Change in The Parenting Stress Index Short Form (PSI) |
-9.60; -1.70 | — |
Summary
A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02903030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.