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Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics (PLAY ON)

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ClinicalTrials.gov Identifier: NCT03181516
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
University of Maryland
Penn State University
Information provided by (Responsible Party):
Daniel Merenstein, Georgetown University

Brief Summary:
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.

Condition or disease Intervention/treatment Phase
Antibiotic-associated Diarrhea Biological: Bifidobacterium animalis subsp. lactis BB-12 Other: Control Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
Experimental: BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Biological: Bifidobacterium animalis subsp. lactis BB-12
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Placebo Comparator: Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Other: Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12




Primary Outcome Measures :
  1. Diarrhea [ Time Frame: 14 days ]
    Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.


Secondary Outcome Measures :
  1. Pediatric quality-of-life score [ Time Frame: 7 days ]
    The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Child is between ages of 3-12 years
  2. Caregiver has the ability to read, speak and write English or Spanish
  3. Household has refrigerator for proper storage of drink
  4. Household has telephone access
  5. Enrollment must take place within 24 hours of starting antibiotics
  6. Child was outpatient treated
  7. Child was prescribed treatment with a penicillin or cephalosporin class antibiotic regimen for 10 days for a respiratory infection;

The following is a list of inclusive antibiotics:

  1. Amoxicillin
  2. Augmentin (amoxicillin/clavulanate)
  3. Ancef (cefazolin)
  4. Cefadroxil
  5. Cephalexin
  6. Cephradine
  7. Duricef (cefadroxil)
  8. Keflex (cephalexin)
  9. Kefzol (cefazolin)
  10. Velosef (cephradine)
  11. Ceclor (cefaclor)
  12. Cefotan
  13. Cefoxitin
  14. Ceftin (cefuroxime)
  15. Cefzil (cefprozil)
  16. Lorabid (loracarbef)
  17. Mefoxin (Cefoxitin)
  18. Zinacef (cefuroxime)
  19. Omnicef (cefdinir)
  20. Suprax (cefixime)
  21. Dicloxacillin
  22. Pen-Vee K (penicillin)

Exclusion Criteria:

  1. Developmental delays
  2. Any chronic condition, such as diabetes or asthma, that requires medication
  3. Prematurity, birth weight <2,500 grams
  4. Congenital anomalies
  5. Failure to thrive
  6. Allergy to strawberry
  7. Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
  8. Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed)
  9. Parental belief of lactose intolerance
  10. History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
  11. History of gastrointestinal surgery or disease
  12. Milk-protein allergy
  13. Allergy to any component of the product or the yogurt vehicle
  14. Allergy to penicillin or cephalosporin class antibiotics
  15. Allergy to any of the following medications:

    1. Tetracycline
    2. Erythromycin
    3. Trimethoprim
    4. Ciprofloxacin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181516


Contacts
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Contact: Daniel Merenstein, MD 2026872745 djm23@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Department of Family Medicine, Research Division Recruiting
Washington, District of Columbia, United States, 20007
Contact: Dan Merenstein, MD         
Principal Investigator: Dan Merenstein, MD         
Sponsors and Collaborators
Georgetown University
University of Maryland
Penn State University
Investigators
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Principal Investigator: Daniel Merenstein, MD Georgetown University

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Responsible Party: Daniel Merenstein, Professor and Director of Research Programs, Georgetown University
ClinicalTrials.gov Identifier: NCT03181516     History of Changes
Other Study ID Numbers: 2016-1489
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents