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


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Verified June 2017 by Daniel Merenstein, Georgetown University

Sponsor:

Information provided by (Responsible Party):

Daniel Merenstein, Georgetown University

ClinicalTrials.gov Identifier:

NCT03181516

First received: June 7, 2017

Last updated: June 7, 2017

Last verified: June 2017

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. Our research group has worked closely with the Federal Drug Administration (FDA) to move research forward for the most well studied Bifidobacterium strain. To explore possible mechanisms, we will also study the gut microbiota composition and function by collecting five fecal samples at multiple time points from all participants. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.

Antibiotic-associated Diarrhea Biological: Bifidobacterium animalis subsp. lactis BB-12
Other: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 300
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Experimental: BB-12

Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt

Biological: Bifidobacterium animalis subsp. lactis BB-12

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Placebo Comparator: Control

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Other: Control

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 an upper 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03181516

Georgetown University

Principal Investigator: Daniel Merenstein, MD Georgetown University

Responsible Party: Daniel Merenstein, Associate Professor and Director of Research Programs, Georgetown University
ClinicalTrials.gov Identifier: NCT03181516     History of Changes
Other Study ID Numbers: 2016-1489
Study First Received: June 7, 2017
Last Updated: June 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 08, 2017