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Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

This study is currently recruiting participants.
Verified March 2013 by Georgetown University
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Daniel Merenstein, Georgetown University
ClinicalTrials.gov Identifier:
NCT01652287
First received: July 5, 2012
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

The investigators believe a readily available drink containing a high dose of probiotics has the potential to improve compliance through many of these mechanisms. This product also has the potential to positively impact the health of children and adults around the world, as yogurt will likely be more appealing to both children and their parents for long term consumption than pharmaceutical-like preparations. In addition to the benefits associated with the consumption of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense food.

More specifically, the rationale for this Phase I study is to determine safety of this yogurt drink and comply with FDA recommendations pertaining to an Investigational New Drug application. The investigators hypothesize that BB-12 is safe in generally healthy children ages 1-5 years.


Condition Intervention Phase
Children
 Drug: BB-12 supplemented strawberry yogurt
Other: Strawberry flavored yogurt
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: Days 0-180 ] [ Designated as safety issue: Yes ]
    The primary outcome is to assess the safety of BB-12 yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.


Secondary Outcome Measures:
  • Presence of BB-12 in the stool samples [ Time Frame: Days 0, 10, 30, 60 and 90 ] [ Designated as safety issue: No ]
    The secondary objective is to assess the ability of BB-12 to survive gastric transit. The presence of BB-12 in the stool samples will be examined from the samples collected on days 0, 10, 30, 60 and 90, ±2 days. We will examine the stools by plating on selective agar as well as examining them directly by PCR to detect the presence of BB-12.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BB-12 supplemented yogurt
Probiotic, Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12), supplemented strawberry yogurt, 4 ounces taken orally for 10 days
 Drug: BB-12 supplemented strawberry yogurt
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
Placebo Comparator: Strawberry flavored yogurt
Placebo, strawberry yogurt, 4 ounces taken orally for 10 days
 Other: Strawberry flavored yogurt
Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Detailed Description:

Probiotics are live microorganisms that, when administered in sufficient amounts, may improve health. A common use for probiotics is in addressing gastrointestinal issues, such as antibiotic-associated diarrhea (AAD). As an alternative to supplements, probiotics are also included as ingredients in fermented dairy products to produce functional foods, which are foods providing health benefits beyond their nutritional value. Yogurt, for example, is a fermented milk product often considered a functional food. One of the most commonly used probiotics is Bifidobacterium animalis ssp. lactis (BB-12).

Our Primary Aim in Years 1-2 is to conduct a pediatric randomized controlled study to establish the safety of BB-12 fortified yogurt in children. Our Secondary Aims are to examine the fecal microbiota of children prior to, during and following consumption of probiotics. This study will evaluate whether a well-defined, probiotic-containing yogurt can safely be used as an effective delivery vehicle for probiotics. This study is important to help advance probiotic research forward in a systematic, well-accepted manner. Our long-term goal is to create yogurt with sufficient probiotic dosages to positively impact many different aspects of childhood and adult health.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for parents/caregivers are:

  1. Ability to read, speak and write English or Spanish
  2. Access to a refrigerator for proper storage of drink
  3. Telephone access

Inclusion criteria for children are:

1. Are between the ages of 1 and 5 years

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 (defined as three or more loose stools for two consecutive days)
  8. Any other medicines used except anti-pyretic medicines (to reduce fever) [excluding as needed medications]
  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. During the baseline physical exam, have an oxygen saturation rate <96% and respiratory and pulse rate outside the normal range per their age.

Parents/caregivers will also be asked to refrain from giving their child any probiotic foods or supplements during the entire 2 weeks of the active intervention period, and 2 weeks before day 1 of starting the yogurt. Parents will be supplied with a list of products to avoid.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652287

Contacts
Contact: Daniel J Merenstein, MD 202-687-2745 djm23@georgetown.edu

Locations
United States, District of Columbia
Georgetown University Department of Family Medicine, Research Division Recruiting
Washington, District of Columbia, United States, 20007
Contact: Daniel Merenstein, MD     202-687-2745     djm23@georgetown.edu    
Principal Investigator: Dan Merenstein, MD            
Sponsors and Collaborators
Georgetown University
Penn State University
Investigators
Principal Investigator: Daniel J Merenstein, MD Georgetown University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Daniel Merenstein, Principal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT01652287     History of Changes
Other Study ID Numbers: 3U01AT003600-02S1
Study First Received: July 5, 2012
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013