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

Georgetown University255 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

255

Conditions

Antibiotic-associated Diarrhea

Interventions

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of Participants Experiencing 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.

Time frame: 14 days

Adverse Events

Number of reported adverse events over the duration of the study

Time frame: Days 0-180

Secondary Outcomes

Pediatric Quality-of-life Score

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.

Time frame: 7 days

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.

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.