Probiotics for Quality of Life in Autism Spectrum Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02903030|
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : December 14, 2017
|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 :||12 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|
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
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) (Varni et al., 2001; (Varni, Burwinkle, & Seid, 2006; Varni et al, 2014) [ Time Frame: Screen, Baseline, Week 4, Week 8, Week 11, Week 15, Week 19 ]A 74-item survey with 14 scales (# of items): stomach pain & hurt (6 items), discomfort when eating (5), food & drink limits (6), trouble swallowing (3), heartburn/reflux (4), nausea/vomiting (4), gas & bloating (7), constipation (14), blood in poop (2), diarrhea (7), worry about going poop (5), worry about stomachaches (2), medicines (4), and communication (5). 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 (Arnold et al, 2003) [ Time Frame: Baseline, Week 4, Week 8, Week 11, Week 15, Week 19 ]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 to disastrously worse, 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 (Scahill, Lecavalier, Bears, & Aman, 2015) [ Time Frame: Screen, Baseline, Week 4, Week 8, Week 11, Week 15, Week 19 ]
- Change in The Aberrant Behavior Checklist (ABC) (Aman et al., 1985a, 1985b) [ Time Frame: Baseline, Week 4, Week 8, Week 11, Week 15, Week 19 ]The ABC is a 58-item parent rating on a 0-3 scale with five subscales: 1) Irritability (includes agitation, aggression, and self-injury, 15 items); 2) Social Withdrawal (16 items); 3) Stereotypies (7 items); 4) Hyperactivity (16 items); and 5) Inappropriate Speech (4 items).
- Change in Social Responsiveness Scale (SRS) (Costantino et al., 2003) [ Time Frame: Baseline, Week 8, Week 11, Week 19 ]This 65-item rating scale measures the severity of autism spectrum symptoms as they occur in natural social settings. Completed by a parent or teacher in 15 to 20 minutes, 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.
- Change in Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, & Mcguinn, 2000) [ Time Frame: Baseline, Week 8, Week 11, Week 19 ]It includes 33 items rated retrospectively over the previous week by parents. 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. In a recent study of the Autism Treatment Network, 75% of the participants analyzed had a CSHQ score >41, the clinical threshold for sleep problems (Hollway, Aman, and Butter, 2013). Sleep greatly affects quality of life for both children and parents, and it is important to detect any changes in this important vegetative function.
- Change in The Parenting Stress Index Short Form (PSI) (Abidin,1995) [ Time Frame: Baseline, Week 8 ]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.
- Change in Vital signs [ Time Frame: Screen, Baseline, Week 4, Week 8, Week 11, Week 15, Week 19 ]
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|