← Back to Search

Probiotic

Combination Probiotic for Autism

Phase 1 & 2
Recruiting
Led By J Marc RHoads, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 21, 56 and 84
Awards & highlights

Study Summary

This trial is looking at the effects of a probiotic on children with autism spectrum disorders. The probiotic will be given at different doses over 56 days, and then there will be a 28 day observation period. The trial will assess safety and tolerability of the probiotic, as well as any effects on behaviors, GI symptoms, and relevant biomarkers.

Who is the study for?
This trial is for healthy children aged 4-16 with autism spectrum disorders and gastrointestinal symptoms, without other illnesses. It's open to all races and genders; girls who can have babies will get a pregnancy test each visit. Kids can't join if they're on laxatives, have certain GI diseases, allergies to antibiotics, fever or serious health issues, are pregnant/breastfeeding, take immune-weakening drugs or had recent antibiotics/probiotics.Check my eligibility
What is being tested?
The study tests two doses of a combination probiotic (BB-12 with LGG) against a placebo in kids with autism over an 84-day period. Researchers want to see how safe it is and its effect on behavior using the SRS-2 and ABC scales, GI symptoms via the GI symptom severity index, and changes in inflammation markers, gut bacteria & metabolites.See study design
What are the potential side effects?
While specific side effects aren't listed here since this trial assesses safety and tolerability of the probiotics BB-12 with LGG at different doses for children with ASD; generally probiotics may cause digestive discomfort like gas or bloating initially.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 21, 56 and 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 21, 56 and 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of BB-12+LGG at different doses on adverse events (safety)
Secondary outcome measures
Anxiety
Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)
Other outcome measures
Effects of BB-12+LGG at different doses on GI symptoms as measured by GI Symptom Severity Index
Effects of BB-12+LGG at different doses on fecal microbial community
Effects of BB-12+LGG at different doses on gut inflammation (Fecal Calprotectin)
+4 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: BB-12 with LGG (Lower Dose)Active Control1 Intervention
BB-12 with LGG (Multistrain probiotic; lower dose): 1 billion CFUs
Group II: BB-12 with LGG (Higher Dose)Active Control1 Intervention
BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs
Group III: PlaceboPlacebo Group1 Intervention
Maltodextrin

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,834 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,955 Previous Clinical Trials
2,672,430 Total Patients Enrolled
Texas Higher Education Coordinating BoardUNKNOWN
2 Previous Clinical Trials
237 Total Patients Enrolled

Media Library

BB-12 with LGG (Higher Dose) (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03514784 — Phase 1 & 2
Autism Research Study Groups: BB-12 with LGG (Lower Dose), Placebo, BB-12 with LGG (Higher Dose)
Autism Clinical Trial 2023: BB-12 with LGG (Higher Dose) Highlights & Side Effects. Trial Name: NCT03514784 — Phase 1 & 2
BB-12 with LGG (Higher Dose) (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03514784 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to enrollees at the moment?

"Affirmative. According to information hosted on clinicaltrials.gov, this experiment is actively recruiting participants and began doing so since May 1st 2016. The study requires 70 individuals from a single trial site for enrolment."

Answered by AI

Does this clinical trial permit geriatric participants?

"For those hoping to join this trial, the age limit is 4-16 years. Clinicialtrials.gov currently lists 421 trials for minors and 653 studies focussing on seniors."

Answered by AI

What other investigations have been undertaken regarding the combination of BB-12 and LGG (at reduced dosage)?

"At the moment, 3 clinical trials are currently assessing BB-12 with LGG (Lower Dose) and none of them have achieved Phase 3. These experiments are primarily located in Houston, Texas but there are a few other medical sites involved as well."

Answered by AI

How many individuals are involved in this research endeavor?

"True. Based on the information displayed on clinicaltrials.gov, this medical trial is in search of participants. It was first uploaded to the site on May 1st 2016 and most recently modified on June 8th 2022 with a goal of recruiting 70 patients from one location."

Answered by AI

For whom is enrollment into this trial available?

"This clinical trial seeks to recruit 70 children with autism spectrum disorder, aged between 4 and 16 years old. Candidates should be in good health and experience gastrointestinal symptoms as defined by the GI Severity Index. No preference will be given based on age, gender or race; however, a urine pregnancy test must take place for female participants of childbearing potential at each visit. The investigators anticipate that most subjects will likely be male minors prior to reaching puberty."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
< 18
What site did they apply to?
UTHealth
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Sep 2025