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

NCT ID: NCT03181516

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2023-10-11

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.

Conditions

Antibiotic-associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

BB-12

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

Group Type: EXPERIMENTAL

Bifidobacterium animalis subsp. lactis BB-12

Intervention Type: BIOLOGICAL

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Control

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Interventions

Bifidobacterium animalis subsp. lactis BB-12

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Intervention Type: BIOLOGICAL

Control

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Intervention Type: OTHER

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Merenstein

Professor and Director of Research Programs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Merenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-1489

Identifier Type: -

Identifier Source: org_study_id