SIPPY: Study to Investigate the Potential of Probiotics in Yogurt

• Sponsor: Georgetown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00492583
• Collaborator: The Gerber Foundation (Other)
• Enrollment: 182
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 14

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Bifidobacterium lactis (BB-12); Drug: Placebo	Phase 3

Detailed Description

It is reported that more than half of all young children attend daycare centers in the United States. Absences due to illnesses are costly both on an individual and societal level; these absences are generally due to diarrhea or upper respiratory infections.

In the U.S., children under five years of age experience 20-35 million episodes of diarrhea per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all visits by children), more than 200,000 hospitalizations (13% of hospital admissions in children under five years), and 325-425 deaths annually. In 1991, the outpatient costs of treating diarrhea in children under age three was calculated at 0.6-1 billion dollars per year.

Respiratory illness is among the leading causes of death in children under five years of age. Approximately 200,000 deaths in the U.S. and 3.9 million deaths worldwide are attributed to respiratory illnesses. Respiratory illness is also the most frequent reason for physician consultation, with more than 40% of all pediatric outpatient visits related to respiratory illness. According to a recent study, 39% of children attending daycare experienced acute otitis media (ear infection) and 26% reported allergies. Most notably, 10% of children attending daycare were admitted to the hospital due to respiratory illnesses.

We have chosen BB-12 as the probiotic for this study as it is one of the best characterized probiotics with a long safety record in children, a well-proven ability to colonize the human intestinal tract, and demonstrated efficacy for different pediatric conditions. Furthermore, BB-12 is a commercially available probiotic strain that has been used in a number of feeding and clinical trials.

In fact, there is a new infant formula on the market, using the identical strain we are, in the first commercially available probiotic infant formula available in the United States. Not only has BB-12 been found to survive transit through the stomach, small intestine and colon, but also long-term consumption of BB-12 formula at levels as high as 1 billion CFU/g (240 g serving) have been found to be safe.

Our overall goal is to demonstrate that a probiotic-containing yogurt beverage can be used successfully as a vehicle for delivering health-enhancing probiotics; more specifically to determine if a yogurt drink containing Bifidobacterium lactis BB-12 at a minimum 1010 colony forming units (CFU)/per serving can prevent daycare absences.

The rationale for focusing on food as a vehicle for the transmission of probiotics is that it has the potential to benefit children more than using probiotics in a more medicinal manner, such as pills or capsules. By providing an intervention in the form of a yogurt drink, parents are given a more convenient and simple alternative to traditional probiotic supplements. As yogurt is known to be a nutrient dense food, a yogurt drink is likely to be more appealing to both children and their parents for long-term consumption than pharmaceutical-like preparations. Although compliance with most medicinal regimens is around 50%, by offering a more attractive formulation of high dose probiotics and collaborating with participants we believe compliance will exceed normal levels. Ultimately, by capitalizing on the widely accepted healthy image of yogurt and offering a simple, convenient source of probiotics, we believe this product has the potential to positively impact the health of children around the world.

Study Design

• Study Type: Interventional
• Actual Enrollment: 182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Study to Investigate the Potential of Probiotics in Yogurt
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink.	Drug: Placebo; The placebo drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus.
Experimental: Bifidobacterium lactis (BB-12) Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink.	Drug: Bifidobacterium lactis (BB-12); The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. The active drink was also supplemented with the probiotic BB-12, acquired from Chr. Hansen (Milwaukee, Wisconsin).

Outcome Measures

Primary Outcome Measures

1. Number of Days Children Are Out of School Sick [90 days]

   Outcome measure, "number of days children are out of school sick" was measured for the entire population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• aged 1-3

• attending daycare or preschool centers at least 3 days a week

• male or female

• parents must speak English or Spanish

• subjects or parents/legal guardians who agree to have their child refrain from consuming any other yogurts or foods containing probiotics for the duration of the study

Exclusion Criteria:

• subjects with developmental delays

• subjects with chronic conditions such as diabetes or asthma that require daily medication

• subjects with birth weight <2500 grams

• subjects with strawberry allergies

• subjects with active diarrhea

• subjects with congenital anomalies

• subjects with failure to thrive

• subjects with parental belief of lactose intolerance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University Department of Family Medicine	Washington	District of Columbia	United States	20007

Sponsors and Collaborators

• Georgetown University
• The Gerber Foundation

Investigators

• Principal Investigator: Daniel J Merenstein, MD, Georgetown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00492583
• Other Study ID Numbers: 2007-273
• First Posted: Jun 27, 2007
• Last Update Posted: Aug 17, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: probiotic; health; bifidobacterium lactis; BB-12

Study Results

Participant Flow

Arm/Group Title	Placebo	Bifidobacterium Lactis (BB-12)
Arm/Group Description
Period Title: Overall Study
STARTED	95	87
COMPLETED	95	87
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Bifidobacterium Lactis (BB-12)	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	95	87	182
Age (Count of Participants)
<=18 years	95 100%	87 100%	182 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex/Gender, Customized (participants) [Number]
Female	36 37.9%	43 49.4%	79 43.4%
Male	50 52.6%	34 39.1%	84 46.2%
Missing	9 9.5%	10 11.5%	19 10.4%
Region of Enrollment (participants) [Number]
United States	95 100%	87 100%	182 100%

Outcome Measures

1. Primary Outcome

Title	Number of Days Children Are Out of School Sick
Description	Outcome measure, "number of days children are out of school sick" was measured for the entire population
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Bifidobacterium Lactis (BB-12)
Arm/Group Description
Measure Participants	95	87
Number [days per 100 person days]	2.51	2.82

Adverse Events

Arm/Group Title	Placebo		Bifidobacterium Lactis (BB-12)
Arm/Group Description
All Cause Mortality
	Placebo		Bifidobacterium Lactis (BB-12)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Bifidobacterium Lactis (BB-12)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Bifidobacterium Lactis (BB-12)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/95 (3.2%)		3/87 (3.4%)
Eye disorders
Hordeolum	1/95 (1.1%)	1	0/87 (0%)	0
Gastrointestinal disorders
Diarrhea	3/95 (3.2%)	3	2/87 (2.3%)	2
Vomiting & Cough	3/95 (3.2%)	3	0/87 (0%)	0
General disorders
Pyrexia	0/95 (0%)	0	1/87 (1.1%)	1
Skin and subcutaneous tissue disorders
Dermatitis (Diaper)	3/95 (3.2%)	3	0/87 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.