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Completed

NCT Number: NCT03181516

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

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.

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Key information

Conditions

Antibiotic-associated Diarrhea

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bifidobacterium animalis subsp. lactis BB-12

Biological

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Control

Other

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Primary outcomes

  1. Number of Participants Experiencing 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.

  2. Adverse Events

    Time frame: Days 0-180

    Number of reported adverse events over the duration of the study

Secondary outcomes

  1. Pediatric Quality-of-life Score

    Time frame: 7 days

    The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory.

    Based on the PedsQL form filled out by participants, the scores were translated using the PedsQL form guidelines: 0=100, 1=75, 2=50,3=25,4=0. The raw scores of participants were averaged after translation. The lowest possible score is 0 and the highest possible score is 100. A higher score indicates a healthier lifestyle.

  2. Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Penn State University
  • University of Maryland, Baltimore

Registry information

Acronym: PLAY ON

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2017
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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