Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

NCT ID: NCT01652287

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-07-31

Brief Summary

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.

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.

Conditions

Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

BB-12 supplemented strawberry yogurt

Intervention Type: DRUG

Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days

Strawberry flavored yogurt

Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Group Type: PLACEBO_COMPARATOR

Strawberry flavored yogurt

Intervention Type: OTHER

Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Interventions

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

Intervention Type: DRUG

Strawberry flavored yogurt

Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Ability to read, speak and write English or Spanish

2. Access to a refrigerator for proper storage of drink

3. Telephone access

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Merenstein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J 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

References

Tan TP, Ba Z, Sanders ME, D'Amico FJ, Roberts RF, Smith KH, Merenstein DJ. Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children. J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):302-309. doi: 10.1097/MPG.0000000000001272.

Reference Type: RESULT

PMID: 28114246 (View on PubMed)

Other Identifiers

3U01AT003600-02S1

Identifier Type: NIH

Identifier Source: org_study_id

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