Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 3 - 12 |
| Updated: | 9/9/2018 |
| Start Date: | September 30, 2017 |
| End Date: | January 2022 |
| Contact: | Daniel Merenstein, MD |
| Email: | djm23@georgetown.edu |
| Phone: | 2026872745 |
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.
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.
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 10 days for a respiratory infection;
The following is a list 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, birth weight <2,500 grams
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 to penicillin or cephalosporin class antibiotics
15. Allergy to any of the following medications:
1. Tetracycline
2. Erythromycin
3. Trimethoprim
4. Ciprofloxacin
We found this trial at
1
site
Washington, District of Columbia 20007
Principal Investigator: Dan Merenstein, MD
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