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

Study Overview
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Brief Summary
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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.

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

Conditions
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Antibiotic-associated Diarrhea

Intervention / Treatment
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* Biological: Bifidobacterium animalis subsp. lactis BB-12
* Other: Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BB-12<br>Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt | Biological: Bifidobacterium animalis subsp. lactis BB-12<br>* Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt<br>|
| Placebo Comparator: Control<br>Yogurt without Bifidobacterium animalis subsp. lactis BB-12 | Other: Control<br>* Yogurt without Bifidobacterium animalis subsp. lactis BB-12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric quality-of-life score | The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory | 7 days | 
| 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. | 14 days |