Clinical trial NCT03181516: Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Official title: Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antibiotic-associated Diarrhea
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Penn State University
name: University of Maryland, Baltimore
First posted: 2017-06-08
Enrollment: 255
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants Experiencing Diarrhea
timeFrame: 14 days
measure: Adverse Events
timeFrame: Days 0-180
Secondary outcomes:
measure: Pediatric Quality-of-life Score
timeFrame: 7 days
measure: 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.
timeFrame: 14 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Department of Family Medicine, Research Division
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Daniel Merenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: