Trial Outcomes & Findings for Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK) (NCT NCT00481507)
NCT ID: NCT00481507
Last Updated: 2019-07-10
Results Overview
The primary outcome was the incidence of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
14 days
Results posted on
2019-07-10
Participant Flow
Participant milestones
| Measure |
Placebo
150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
|
Kefir
150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics 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.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
61
|
|
Overall Study
COMPLETED
|
64
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
|
Kefir
n=61 Participants
150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics 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.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
61 participants
n=7 Participants
|
125 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Prior estimates of the sample size showed that 62 per group would have 80% power for detecting a difference of 20% in the rates of diarrhea. This was based on the placebo group having a 10% (which is consistent with published literature) rate of diarrhea. Analysis performed used the intention to treat and no imputation was required.
The primary outcome was the incidence of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.
Outcome measures
| Measure |
Kefir
n=61 Participants
150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics 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.
|
Placebo
n=64 Participants
150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
|
|---|---|---|
|
Incidence of Participants With Diarrhea by Parental Report
|
18.0 Percentage of participants
Interval 9.0 to 30.0
|
21.9 Percentage of participants
Interval 13.0 to 24.0
|
SECONDARY outcome
Timeframe: 14 daysIncidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools. Outcomes assessed by parental report via daily diary and phone follow-ups with study research assistants on days 0, 5, 10, and 15.
Outcome measures
| Measure |
Kefir
n=61 Participants
150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics 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.
|
Placebo
n=64 Participants
150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
|
|---|---|---|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
lethargy
|
16.4 Percentage of participants
Interval 8.0 to 28.0
|
21.9 Percentage of participants
Interval 13.0 to 46.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
vomiting
|
16.4 Percentage of participants
Interval 8.0 to 28.0
|
10.9 Percentage of participants
Interval 5.0 to 21.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
stomach pain
|
8.2 Percentage of participants
Interval 3.0 to 18.0
|
14.1 Percentage of participants
Interval 7.0 to 25.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
constipation
|
19.7 Percentage of participants
Interval 11.0 to 32.0
|
17.2 Percentage of participants
Interval 9.0 to 29.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
runny nose
|
77.0 Percentage of participants
Interval 65.0 to 87.0
|
82.8 Percentage of participants
Interval 71.0 to 91.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
cough
|
68.9 Percentage of participants
Interval 56.0 to 80.0
|
53.1 Percentage of participants
Interval 40.0 to 66.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
earaches
|
23.0 Percentage of participants
Interval 13.0 to 36.0
|
17.2 Percentage of participants
Interval 9.0 to 29.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
fever
|
45.9 Percentage of participants
Interval 33.0 to 59.0
|
39.1 Percentage of participants
Interval 27.0 to 52.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
irritability
|
19.7 Percentage of participants
Interval 11.0 to 32.0
|
18.8 Percentage of participants
Interval 10.0 to 31.0
|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
loose stools
|
29.5 Percentage of participants
Interval 19.0 to 43.0
|
32.8 Percentage of participants
Interval 22.0 to 46.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Kefir
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=64 participants at risk
150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
|
Kefir
n=61 participants at risk
150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics 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.
|
|---|---|---|
|
Gastrointestinal disorders
emesis
|
0.00%
0/64
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
1.6%
1/64 • Number of events 1
|
0.00%
0/61
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place