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

NCT03181516 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016-1489
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing 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

• Adverse Events

  Number of reported adverse events over the duration of the study

  Days 0-180

Secondary Outcomes (2)

• Pediatric Quality-of-life Score

  7 days

• 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.

  14 days

Study Arms (2)

BB-12

EXPERIMENTAL

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

Biological: Bifidobacterium animalis subsp. lactis BB-12

Control

PLACEBO COMPARATOR

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Other: Control

Interventions

Bifidobacterium animalis subsp. lactis BB-12 BIOLOGICAL

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

BB-12

Control OTHER

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Control

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child is between ages of 3-12 years
• Caregiver has the ability to read, speak and write English or Spanish
• Household has refrigerator for proper storage of drink
• Household has telephone access
• Enrollment must take place within 24 hours of starting antibiotics
• Child was outpatient treated
• 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:
• Amoxicillin
• Augmentin (amoxicillin/clavulanate)
• Ancef (cefazolin)
• Cefadroxil
• Cephalexin
• Cephradine
• Duricef (cefadroxil)

You may not qualify if:

• Developmental delays
• Any chronic condition, such as diabetes or asthma, that requires medication
• Prematurity, or born prior to 37 weeks gestation/of pregnancy
• Congenital anomalies
• Failure to thrive
• Allergy to strawberry
• Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
• Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed)
• Parental belief of lactose intolerance
• History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
• History of gastrointestinal surgery or disease
• Milk-protein allergy
• Allergy to any component of the product or the yogurt vehicle
• Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider
• Allergy to any of the following medications:

Sponsors & Collaborators

• Georgetown University: lead
• Penn State University: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, 20007, United States

Location

Results Point of Contact

• Title: Dr. Daniel Merenstein
• Organization: Georgetown University Medical Center

djm23@georgetown.edu

2026872745

Study Officials

• Daniel Merenstein, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Research Programs

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 8, 2017
• Study Start: September 30, 2017
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)