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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
Must not have
Current use of oral laxatives
Gastrointestinal diseases such as celiac disease, inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 21, 56 and 84

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking oral laxatives.
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I have a gastrointestinal condition like celiac or inflammatory bowel disease.
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I will not consume any probiotics or probiotic-enriched foods during the study.
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I am currently taking medications that suppress my immune system.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effects of BB-12+LGG at different doses on adverse events (safety)
Secondary study objectives
Anxiety
Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)
Other study objectives
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
950 Previous Clinical Trials
344,975 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,056 Previous Clinical Trials
2,738,074 Total Patients Enrolled
Texas Higher Education Coordinating BoardUNKNOWN
3 Previous Clinical Trials
317 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
~7 spots leftby Dec 2025
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