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Probiotic
Probiotic Yogurt for Antibiotic-Associated Diarrhea (PLAY ON Trial)
Phase 2
Waitlist Available
Led By Daniel Merenstein, MD
Research Sponsored by Georgetown University
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 14 days
Awards & highlights
PLAY ON Trial Summary
This trial is testing whether a specific probiotic can help prevent antibiotic-associated diarrhea in children.
Who is the study for?
This trial is for healthy children aged 3-12 on antibiotics for respiratory infections, who have access to a fridge and whose caregivers can communicate in English or Spanish. It's not suitable for kids with chronic conditions like diabetes or asthma, those with heart disease, gastrointestinal issues, allergies to certain antibiotics or milk protein, lactose intolerance beliefs, prematurity, congenital anomalies, or active diarrhea.Check my eligibility
What is being tested?
The study tests if high-dose BB-12 probiotic yogurt can prevent antibiotic-associated diarrhea in children taking antibiotics compared to regular yogurt. It also examines the safety of this probiotic-enriched yogurt and its effects on the diversity of gut bacteria over time.See study design
What are the potential side effects?
While specific side effects are not listed here, generally probiotics like BB-12 are considered safe but may cause digestive discomfort such as gas or bloating initially. Any unexpected reactions related to the consumption of the supplemented yogurt will be closely monitored.
PLAY ON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diarrhea
Secondary outcome measures
Pediatric quality-of-life score
Symptoms of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.
PLAY ON Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BB-12Experimental Treatment1 Intervention
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Group II: ControlPlacebo Group1 Intervention
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bifidobacterium animalis subsp. lactis BB-12
2017
Completed Phase 2
~260
Find a Location
Who is running the clinical trial?
Penn State UniversityOTHER
355 Previous Clinical Trials
125,502 Total Patients Enrolled
1 Trials studying Antibiotic-associated Diarrhea
138 Patients Enrolled for Antibiotic-associated Diarrhea
University of Maryland, BaltimoreOTHER
687 Previous Clinical Trials
374,391 Total Patients Enrolled
2 Trials studying Antibiotic-associated Diarrhea
204 Patients Enrolled for Antibiotic-associated Diarrhea
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,247 Total Patients Enrolled
2 Trials studying Antibiotic-associated Diarrhea
204 Patients Enrolled for Antibiotic-associated Diarrhea
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a delay in your physical or mental development.You have a long-term medical condition, like diabetes or asthma, that needs regular medication.You are not growing or gaining weight properly.You have a refrigerator at home to store drinks properly.You are allergic to milk protein.You cannot take any medications other than fever reducers, except for occasional medicines that may be needed.You were born before 37 weeks of pregnancy.You were born with physical abnormalities.You are allergic to any ingredient in the product or the yogurt used as a vehicle.The child is between 3 and 12 years old.The participant's parent or guardian believes they are lactose intolerant.You are allergic to strawberries.You have been experiencing frequent loose stools for two or more days.
Research Study Groups:
This trial has the following groups:- Group 1: BB-12
- Group 2: Control
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA officially sanctioned Bifidobacterium animalis subsp. lactis BB-12?
"After careful evaluation, our team at Power rated the safety of Bifidobacterium animalis subsp. lactis BB-12 as a 2 since this is only in Phase 2 clinical trials and there is limited information currently available on its efficacy."
Answered by AI
What is the aggregate size of the cohort involved in this experiment?
"Affirmative. As evidenced by clinicaltrials.gov, this medical investigation is currently enrolling participants; the trial was posted on September 30th 2017 and has since been updated on June 27th 2022. This study seeks to enlist 300 people from a single location."
Answered by AI
Does this medical experiment currently have openings for participants?
"According to the data hosted on clinicaltrials.gov, this medical trial is actively seeking participants and was initially posted on September 30th 2017 with its most recent edit being June 27th 2022."
Answered by AI
Is the enrollment criteria for this investigation limited to individuals over 40 years of age?
"This trial is specifically designed for children between the ages of 3 and 12. Patients younger than 18 have 28 other clinical trials available to them, while seniors over 65 can access 46 different studies."
Answered by AI
Am I eligible to be a participant in this clinical trial?
"Those interested in this clinical trial must be aged between 3 and 12, while also presenting with diarrhea. The study is seeking to recruit a total of 300 individuals."
Answered by AI
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