Beneficial Bacteria Treatment for Autism (BBT)

Arizona State University (ASU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gastrointestinal Problems; Autism Spectrum Disorders

Treatments: Drug: MoviPrep; Drug: Prilosec; Drug: oral Vancomycin; Biological: human fecal material; processed, frozen; administered orally and rectally; Biological: human fecal material; processed, frozen administered orally

Study type: Interventional

Funder types: Other

Identifiers

NCT02504554

STUDY00001053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Oral Group

Experimental group

Description:

This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.

Treatment:

Biological: human fecal material; processed, frozen administered orally

Drug: oral Vancomycin

Drug: Prilosec

Drug: MoviPrep

Rectal Group

Experimental group

Description:

This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.

Treatment:

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

Drug: oral Vancomycin

Drug: Prilosec

Drug: MoviPrep