NCT00481507

Brief Summary

The purpose of this study is to determine the effectiveness of commercially available kefir on preventing antibiotic-associated diarrhea compared to placebo in children ages 1-5.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

May 30, 2007

Results QC Date

May 9, 2011

Last Update Submit

July 3, 2019

Conditions

Respiratory Tract Infections

Keywords

ProbioticCultured dairy drinkHealth10 day antibioticOtherwise healthy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Participants With Diarrhea by Parental Report

    The primary outcome was the incidence of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.

    14 days

Secondary Outcomes (1)

  • Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools

    14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Kefir

EXPERIMENTAL
Other: Kefir

Interventions

KefirOTHER

The intervention was Kefir,a drink that is commercially available in the United States. The following probiotics are present in the Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150mL) everyday.

Kefir
PlaceboOTHER

The intervention was Kefir, a drink that is commercially available in the United States. The following probiotics are present in active Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. The placebo group was heat-treated to kill all cultures. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150 mL)everyday.

Placebo

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ability to speak and write English
  • Aged 1-5 years
  • Male or female
  • Diagnosed with an upper respiratory infection and placed on a penicillin class antibiotic regimen for 10 days

You may not qualify if:

  • Developmental delays
  • Chronic conditions, such as diabetes or asthma, that require medication
  • Prematurity, birth weight \<2500 grams
  • Allergy to kefir and/or milk
  • Active diarrhea
  • Congenital anomalies
  • Failure to thrive
  • Parental belief of lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Deptartment of Family Medicine

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

Location

Related Publications (1)

  • Merenstein DJ, Foster J, D'Amico F. A randomized clinical trial measuring the influence of kefir on antibiotic-associated diarrhea: the measuring the influence of Kefir (MILK) Study. Arch Pediatr Adolesc Med. 2009 Aug;163(8):750-4. doi: 10.1001/archpediatrics.2009.119.

    PMID: 19652108RESULT

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Kefir

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fermented BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaCultured Milk ProductsMilkFermented FoodsDairy ProductsFoodFood and Beverages

Limitations and Caveats

We did not assess or culture stools for the presence of pathogenic organisms. We did not independently examine children; we relied on parental/patient-oriented outcomes. Our population was generally very healthy. We did not assess probiotic dosages.

Results Point of Contact

Title
Daniel Merenstein, MD
Organization
GEORGETOWN UNIVERSITY
djm23@georgetown.edu
202-687-2745

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
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 10, 2019

Results First Posted

March 26, 2012

Record last verified: 2019-07

Locations

US(1)