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

Primary Purpose

Antibiotic-associated Diarrhea

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bifidobacterium animalis subsp. lactis BB-12
Control
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-associated Diarrhea

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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 7-10 days for a respiratory infection;

The following is a list (non-exhaustive) 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, or born prior to 37 weeks gestation/of pregnancy
  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 or a hypersensitivity to the antibiotic prescribed by her/his provider

  15. Allergy to any of the following medications:

    1. Tetracycline
    2. Erythromycin
    3. Trimethoprim
    4. Ciprofloxacin
  16. blood oxygen saturation is less than 90% (if enrollment/baseline visit is completed in person and if the participant was prescribed antibiotics during a telemedicine visit)

Sites / Locations

  • Georgetown University Department of Family Medicine, Research Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BB-12

Control

Arm Description

Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Outcomes

Primary Outcome Measures

Diarrhea
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

Pediatric quality-of-life score
The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory
Symptoms of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.
This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.

Full Information

First Posted
June 7, 2017
Last Updated
August 15, 2023
Sponsor
Georgetown University
Collaborators
University of Maryland, Baltimore, Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT03181516
Brief Title
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Acronym
PLAY ON
Official Title
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
University of Maryland, Baltimore, Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BB-12
Arm Type
Experimental
Arm Description
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Intervention Type
Biological
Intervention Name(s)
Bifidobacterium animalis subsp. lactis BB-12
Intervention Description
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Primary Outcome Measure Information:
Title
Diarrhea
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pediatric quality-of-life score
Description
The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory
Time Frame
7 days
Title
Symptoms of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.
Description
This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child is between ages of 3-12 years Caregiver has the ability to read, speak and write English or Spanish Household has refrigerator for proper storage of drink Household has telephone access Enrollment must take place within 24 hours of starting antibiotics Child was outpatient treated Child was prescribed treatment with a penicillin or cephalosporin class antibiotic regimen for 7-10 days for a respiratory infection; The following is a list (non-exhaustive) of inclusive antibiotics: Amoxicillin Augmentin (amoxicillin/clavulanate) Ancef (cefazolin) Cefadroxil Cephalexin Cephradine Duricef (cefadroxil) Keflex (cephalexin) Kefzol (cefazolin) Velosef (cephradine) Ceclor (cefaclor) Cefotan Cefoxitin Ceftin (cefuroxime) Cefzil (cefprozil) Lorabid (loracarbef) Mefoxin (Cefoxitin) Zinacef (cefuroxime) Omnicef (cefdinir) Suprax (cefixime) Dicloxacillin Pen-Vee K (penicillin) Exclusion Criteria: Developmental delays Any chronic condition, such as diabetes or asthma, that requires medication Prematurity, or born prior to 37 weeks gestation/of pregnancy Congenital anomalies Failure to thrive Allergy to strawberry Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days) Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed) Parental belief of lactose intolerance History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic History of gastrointestinal surgery or disease Milk-protein allergy Allergy to any component of the product or the yogurt vehicle Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider Allergy to any of the following medications: Tetracycline Erythromycin Trimethoprim Ciprofloxacin blood oxygen saturation is less than 90% (if enrollment/baseline visit is completed in person and if the participant was prescribed antibiotics during a telemedicine visit)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Merenstein, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Department of Family Medicine, Research Division
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

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