Last updated: May 6, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting
Phase
1/2
Condition
Asperger's Disorder
Autism
Williams Syndrome
Treatment
Placebo
BB-12 with LGG (Higher Dose)
BB-12 with LGG (Lower Dose)
Clinical Study ID
NCT03514784
HSC-MS-17-0995
R01HD095158-02
Ages 4-16 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy children with autism spectrum disorders (4 - 16 years old) andgastrointestinal symptoms, based on the GI Severity Index, with no other recognizedillness will be enrolled in this study. There will be no selection on the basis ofage, race, or gender. Although the investigators anticipate the majority of subjectswill be male and/or pre-pubertal, in females of childbearing potential, a pregnancytest (urine) will be performed on females participating (at each visit).
Exclusion
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 30 days
- Acute diarrheal illness within the past 30 days
- Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals Current useof oral laxatives
- Subjects with implanted prosthetic devices including prosthetic heart valves
- The investigators will require that subject not take any other probiotic-containingproducts, including yogurt supplemented with probiotics during the study period.
Study Design
Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
May 01, 2016
Estimated Completion Date:
December 31, 2025
Connect with a study center
UTHealth
Houston, Texas 77030
United StatesActive - Recruiting
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