Beneficial Bacteria Treatment for Autism

Autism Spectrum Disorders Clinical Trial

— BBT  

Official title:

Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504554
• Other study ID #: STUDY00001053
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: November 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Children ages 7-17 years

2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)

3. Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items

4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial

5. General good physical health aside from gastrointestinal problems

6. Cognitive Ability to Provide Informed Assent

Exclusion Criteria:

1. Antibiotics in last 6 months

2. Probiotics in last 3 months

3. Single-gene disorder (Fragile X, etc.)

4. Major brain malformation

5. Tube feeding

6. Severe gastrointestinal problems that require immediate treatment (life-threatening)

7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions

8. Severely underweight/malnourished

9. Recent or scheduled surgeries

10. Current participation in other clinical trials

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder
• Gastrointestinal Problems

Intervention

Drug:
• oral Vancomycin
an antibiotic
• MoviPrep
a bowel cleanse
• Prilosec
a stomach acid suppressan

Biological:
• human fecal material; processed, frozen administered orally
human fecal material; processed, frozen, administered orally
• human fecal material; processed, frozen; administered orally and rectally
human fecal material; processed, frozen; administered orally and rectally

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Arizona State University	Northern Arizona University, University of Arizona, University of Minnesota

References & Publications (1)

Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 10 weeks (end of treatment)
Secondary	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.	Baseline and 10 weeks (end of treatment)
Secondary	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)	Baseline and 10 weeks (end of treatment)
Secondary	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.	Baseline and 10 weeks (end of treatment)
Secondary	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.	Baseline and 10 weeks (end of treatment)
Secondary	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.	baseline and 10 weeks
Secondary	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.	baseline and 18 weeks (8 weeks after treatment stopped)
Secondary	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.	Baseline and 10 weeks (end of treatment)