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

Antibiotic-associated Diarrhea Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181516
• Other study ID #: 2016-1489
• Status: Completed
• Phase: Phase 2
• Start date: September 30, 2017
• Est. completion date: October 11, 2023

Study information

• Verified date: June 2024
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: October 11, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Diarrhea

Intervention

Biological:
• Bifidobacterium animalis subsp. lactis BB-12
Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Other:
• Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Locations

Country	Name	City	State
United States	Georgetown University Department of Family Medicine, Research Division	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	Penn State University, University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhea	Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.	14 days
Primary	Adverse events	Number of reported adverse events over the duration of the study	Days 0-180
Secondary	Pediatric quality-of-life score	The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory	7 days
Secondary	Symptoms of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.	This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.	14 days