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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 21, 56 and 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 21, 56 and 84
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 moreTrial 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
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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
916 Previous Clinical Trials
324,422 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,982 Previous Clinical Trials
2,682,812 Total Patients Enrolled
Texas Higher Education Coordinating BoardUNKNOWN
2 Previous Clinical Trials
237 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand a pregnancy test is required for women who can have children.I am currently taking oral laxatives.My child has autism and GI issues, is aged 4-16, and is otherwise healthy.I have a gastrointestinal condition like celiac or inflammatory bowel disease.I will not consume any probiotics or probiotic-enriched foods during the study.I currently have a fever or an ongoing health issue being tracked in the study.I have not taken probiotics in the last 30 days.I have taken antibiotics or anti-fungals in the last 2 weeks.I have had diarrhea in the last 30 days.I am currently taking medications that suppress my immune system.My child has autism and GI issues but is otherwise healthy.
Research Study Groups:
This trial has the following groups:- Group 1: BB-12 with LGG (Lower Dose)
- Group 2: Placebo
- Group 3: BB-12 with LGG (Higher Dose)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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