Road to Discovery for Combination Probiotic BB-12 With LGG in Treating Autism Spectrum Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 4 - 15 |
| Updated: | 1/27/2018 |
| Start Date: | May 2016 |
| End Date: | August 2019 |
| Contact: | J. Marc Rhoads, M.D. |
| Email: | j.marc.rhoads@uth.tmc.edu |
| Phone: | 713-500-7642 |
This study will evaluate the safety and tolerability of combination probiotic BB-12 with LGG
in healthy children with autism spectrum disorder aged 4-15 years. Subjects will be
randomized to BB-12 with LGG orally (LGG dose: 10^9 c.f.u.'s; BB-12: 10^9) for a total of 56
doses or placebo (maltodextrin) at 2:1 ratio. The time on study treatment is 56 days, and the
target sample size is 30 individuals (i.e., 20 in the treatment arm and 10 in the placebo
arm).
in healthy children with autism spectrum disorder aged 4-15 years. Subjects will be
randomized to BB-12 with LGG orally (LGG dose: 10^9 c.f.u.'s; BB-12: 10^9) for a total of 56
doses or placebo (maltodextrin) at 2:1 ratio. The time on study treatment is 56 days, and the
target sample size is 30 individuals (i.e., 20 in the treatment arm and 10 in the placebo
arm).
Inclusion Criteria:
- Healthy children with autism spectrum disorders (4 - 15 years old) with
gastrointestinal symptoms but no other recognized illness will be enrolled in this
study.
- There will be no selection on the basis of age, race, or gender.
Exclusion Criteria:
- Pregnancy or breastfeeding
- Subjects taking immunosuppressive medications, including oral corticosteroids
- A history of positive result of HIV, Hepatitis B, and/or Hepatitis C test
- Abnormal lab test results (Section 5.2)
- Gastrointestinal diseases such as celiac disease, inflammatory bowel disease
- Subjects with an allergy to antibiotics
- Presence of fever or a pre-existing adverse event monitored in the study
- Use of probiotics in the last 90 days
- Acute diarrheal illness within the past 30 days
- Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals
- Current use of oral laxatives
- Subjects with implanted prosthetic devices including prosthetic heart valves
- We will require that subject not take any other probiotic-containing products,
including yogurt supplemented with probiotics during the study period.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Marc Rhoads, M.D.
Phone: 713-500-7642
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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