Using probiotics to treat gastrointestinal symptoms in children with autism

Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders

This study is testing if giving probiotics to children with autism can help improve their stomach issues and behaviors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 4 Years to 16 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT03514784 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of two different doses of the probiotics BB-12 and LGG on gastrointestinal symptoms and behaviors in healthy children aged 4 to 16 with autism spectrum disorder (ASD). Conducted as a blinded randomized controlled trial, it will assess safety, tolerability, and potential benefits over a 56-day treatment period followed by a 28-day observation phase. The study will utilize various assessment tools, including the SRS-2 and GI symptom severity index, to evaluate outcomes. The research is being conducted at the University of Texas Health Science Center at Houston and involves collaboration with experts in microbiome research.

Who should consider this trial

Good fit: Ideal candidates are healthy children aged 4 to 16 with autism spectrum disorder and gastrointestinal symptoms.

Not a fit: Patients with significant gastrointestinal diseases or those taking immunosuppressive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve gastrointestinal symptoms and behavioral outcomes in children with autism spectrum disorder.

How similar studies have performed: While the use of probiotics in autism is an emerging area, previous studies have shown mixed results, indicating that this approach is still being explored.

Eligibility criteria

Inclusion Criteria:

* Healthy children with autism spectrum disorders (4 - 16 years old) and gastrointestinal symptoms, based on the GI Severity Index, with no other recognized illness will be enrolled in this study. There will be no selection on the basis of age, race, or gender. Although the investigators anticipate the majority of subjects will be male and/or pre-pubertal, in females of childbearing potential, a pregnancy test (urine) will be performed on females participating (at each visit).

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 use of oral laxatives
* Subjects with implanted prosthetic devices including prosthetic heart valves
* The investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.

Where this trial is running

Houston, Texas

• UTHealth — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: J Marc RHoads, MD — The University of Texas Health Science Center, Houston
• Study coordinator: J. Marc Rhoads, MD

Conditions: Autism Spectrum Disorder, Gastrointestinal Symptoms, Autism Spectrum Disorder, ASD, Gastrointestinal Symptoms, Constipation, Diarrhea