Phase 2 N=255 Randomized Double-blind Prevention

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

Antibiotic-associated Diarrhea

Bottom Line

View on ClinicalTrials.gov: NCT03181516 ↗

Enrolled (actual)

255

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Number of Participants Experiencing Diarrhea — 3; 2; 122; 128 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bifidobacterium animalis subsp. lactis BB-12 (Biological); Control (Other)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: Georgetown University
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing Diarrhea	3; 2; 122; 128	—
PRIMARY Adverse Events	144; 148	—
SECONDARY Pediatric Quality-of-life Score	85; 91	—
SECONDARY 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.	25; 19; 15; 21; 11; 14	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03181516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.