This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders. The combination therapy includes beneficial bacteria.
This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders. It involves a combination therapy including beneficial bacteria.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Gastrointestinal Symptom Responsiveness Scale (GSRS)
The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7.
Time frame: Baseline and 10 weeks (end of treatment)
Parent Global Impressions-Revised (PGI-R)
The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3.
Time frame: Baseline and 10 weeks (end of treatment)
Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)
Number of participants who had a clinically significant change in their blood safety markers (comprehensive metabolic panel including kidney/liver function and complete blood count with differential)
Time frame: Baseline and 10 weeks (end of treatment)
Childhood Autism Rating Scale (CARS)
The CARS is an assessment of 15 autism-related symptoms. Each item is scored on a scale of 1 (no symptoms) to 4 (severe symptoms), and the scores for each symptom are summed to obtain a total score. So, the possible scores range from 15 to 60, with a higher score indicating greater severity.
Time frame: Baseline and 10 weeks (end of treatment)
Social Responsiveness Scale (SRS)
The SRS is an assessment of social skills based on 65 items, where each item is scored on a range of 0 (no symptoms) to 3 (severe symptoms). The total score is a sum of the individual scores, so the total possible range is from 0 to 195, with a higher score indicating greater severity of symptoms.
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human fecal material; processed, frozen, administered orally
human fecal material; processed, frozen; administered orally and rectally
Time frame: Baseline and 10 weeks (end of treatment)
Short Sensory Profile
The Short Sensory Profile is an assessment of sensory problems. However, the data on this scale was not collected due to administrative error.
Time frame: baseline and 10 weeks
Vineland Adaptive Behavior Scale (VABS)
The VABS is an assessment of adaptive behaviors, and we analyzed it to determine the developmental age of the participants, with possible scores ranging from 0 years to 21 years.
Time frame: baseline and 18 weeks (8 weeks after treatment stopped)
Daily Stool Record (DSR)
The DSR is a record of the type of stool that a participant had each day, using the Bristol Stool Form which ranges from 1 (very hard) to 7 (liquid). We then analyzed the data as % days of abnormal stools over a 14 day period, where an abnormal stool is defined as an unusually hard stool (types 1-2), unusually soft stool (types 6-7), or no stool that day. So, the possible range of % days of abnormal stools is from 0% to 100%, with a higher score indicating a more severe problem.
Time frame: Baseline and 10 weeks (end of treatment)