Probiotics for Quality of Life in Autism Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT02903030|
Recruitment Status : Completed
First Posted : September 16, 2016
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders Anxiety||Drug: Maltose (placebo) Drug: Visbiome Extra Strength||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Probiotics for Quality of Life in Autism Spectrum Disorders|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||December 1, 2017|
Experimental: Visbiome, Then Placebo
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
It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
Placebo Comparator: Placebo, Then Visbiome
Placebo matched to probiotic.
Drug: Maltose (placebo)
Maltose with a trace amount of silicon dioxide
Other Name: Maltose with silicon dioxide
- Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8 [ Time Frame: Baseline and Week 8 of Both the First and Second Intervention ]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).
- Change in Target Symptom Rating From Baseline at Week 8 [ Time Frame: Baseline and Week 8 of Both the First and Second Intervention ]Parents are asked to name the 2 problems of most concern to them at baseline; a clinician helps the parent quantify and describe the problem (frequency, duration, severity, interference with daily life) at baseline. At subsequent visits the clinician reminds the parent of the previous description and helps them again quantify/describe the current state. A panel of blind clinicians reviews the descriptions and rates each on a 9-point scale relative to baseline, from remission (0) to disastrously worse (9), with 5=no change. These ratings are averaged, capturing the issues of most concern to parents across families. For purposes of this study, one of the 2 problems will be required to pertain to GI function, and will be analyzed separately as well as being averaged into the overall symptom rating.
- Change in Parent Anxiety Checklist--ASD From Baseline at Week 8 [ Time Frame: Baseline and Week 8 of Both the First and Second Intervention ]A 25-item single-factor scale measure of emotional stability/anxiety. Higher scores are worse for PRAS-ASD subscale, hence a negative estimate means more improvement with the probiotics compared to control. Scores range from 0-75.
- Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8 [ Time Frame: Baseline and Week 8 of Both the First and Second Intervention ]
The ABC is a 58-item parent rating on a 0-3 scale with five subscales:
- Irritability (includes agitation, aggression, and self-injury, 15 items) with range of scores from 0-45
- Social Withdrawal (16 items) with range of scores from 0-48
- Stereotypies (7 items) with range of scores from 0-21
- Hyperactivity (16 items) with range of scores from 0-48
- Inappropriate Speech (4 items) with range of scores from 0-12.
Higher scores are worse for the ABC subscale, hence a negative estimate means more improvement with the probiotics compared to control.
- Change in Social Responsiveness Scale (SRS) From Baseline at Week 8 [ Time Frame: Baseline and Week 8 of Both the First and Second Intervention ]This 65-item rating scale measures the severity of autism spectrum symptoms as they occur in natural social settings. The SRS provides a clear picture of a child's social impairments, assessing social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits. It is appropriate for use with children from 4 to 18 years of age and will detect changes in core ASD symptoms. A higher score in this scale represents worse symptoms with raw scores summed and generated t-scores ranging from 0-110.
- Children's Sleep Habits Questionnaire (CSHQ) at Week 8 [ Time Frame: Week 8 of Both the First and Second Intervention ]It includes 33 items rated retrospectively over the previous week by parents yielding a total score and eight subscales. Eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness.Total score (summed) range of 0-99. A higher score is a better outcome for this measure.
- Change in The Parenting Stress Index Short Form (PSI) [ Time Frame: Baseline and Week 8 of Both the First and Second Intervention ]The PSI is used to evaluate the degree of stress in the parent-child relationship. The Short Form has 36 items from the full length PSI, rated on a 5-point scale from 1 = strongly disagree, to 5 = strongly agree. It is completed in 10-15 minutes. The PSI may be used for parents of children up to 12 years. It yields a Total Score and three domain scores. This will detect effect on parental stress and QOL. Higher scores (ranging from 0-180) are worse for PSI, hence a negative estimate means more improvement with the probiotics compared to control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903030
|United States, Ohio|
|Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Eugene Arnold, MD||Ohio State University|