Road to Discovery for Combination Probiotic BB-12 With LGG in Treating Autism Spectrum Disorder

Inflammation Clinical Trial

Official title:

Road to Discovery for Combination Probiotic BB-12 With LGG in Treating Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674984
• Other study ID #: HSC-MS-15-0751
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: November 2019

Study information

• Verified date: November 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Inflammation

Intervention

Drug:
• BB-12 with LGG
Multistrain probiotic
• Placebo

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Texas Higher Education Coordinating Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of combination probiotic BB-12+LGG on GI symptoms as measured by GI Symptom Severity Index	GI symptoms will be measured by the GI Severity Index.	Days 1, 21, 56 and 84
Other	Effect of combination probiotic BB-12+LGG on gut inflammation	Biological change in fecal calprotectin levels and plasma S100A9 will indicate GI and systemic levels of inflammation. S100 is a damage-associated molecular pattern molecule (DAMP) released by granulocytes, which is reportedly elevated 2-fold in plasma of children with ASD. FC is a highly accurate fecal marker of inflammation. Plasma zonulin, a marker for intestinal permeability ("leaky gut"), which is often associated with inflammation.	Days 1, 56 and 84
Other	Effect of combination probiotic BB-12+LGG on fecal microbial community and metabolites	We will determine microbial alpha and beta diversity and distribution of the major taxa before and after probiotic treatment. Because bacterial products may be equally or more important than their community structure, we will determine levels of metabolic markers which are reported to be abnormal in autism: fecal amino acids, ammonia, short chain fatty acids (SCFA), and phenols.	Days 1, 56 and 84
Primary	Effect of combination probiotic BB-12+LGG on adverse events assessed by case report form (survey) that are related to BB-12 with LGG (health-promoting bacteria) or placebo treatment.	The symptom grade will detail the severity of adverse events by scoring. Graded scores between 1 - 4.	84 days
Secondary	Effect of combination probiotic BB-12+LGG on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)	Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the Aberrant Behavior Checklist (ABC) pre and post treatment	Days 1, 21, 56 and 84
Secondary	Effect of combination probiotic BB-12+LGG on irritability and maladaptive behaviors measured with the Social Responsiveness Scale-2	Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the and the Social Responsiveness Scale-2 (SRS-2) pre and post treatment.	Days 1, 21, 56 and 84