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Combination Probiotic for Autism
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- 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.
- Group 1: BB-12 with LGG (Lower Dose)
- Group 2: Placebo
- Group 3: BB-12 with LGG (Higher Dose)
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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