Trial Outcomes & Findings for Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic (NCT NCT03434249)
NCT ID: NCT03434249
Last Updated: 2020-01-23
Results Overview
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)
COMPLETED
NA
80 participants
at 28 days from the baseline (Visit T5)
2020-01-23
Participant Flow
The study was a randomized, double-blind, placebo-controlled parallel-group study. Eighty (80) infants were screened and all were enrolled in the study and randomized (40 to Bifidobacteriium BB-12® and 40 to Placebo). The enrollment period started on 11-Nov-2016 and closed on 6-Nov-2017.
Participant milestones
| Measure |
Bifidobacterium BB-12®
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days.
|
Placebo
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Bifidobacterium BB-12®
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days.
|
Placebo
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Non-compliance of family
|
2
|
1
|
|
Overall Study
Difficulties in completing daily diary
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.05 days
STANDARD_DEVIATION 5.03 • n=40 Participants
|
32.73 days
STANDARD_DEVIATION 5.69 • n=40 Participants
|
32.89 days
STANDARD_DEVIATION 5.34 • n=80 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=40 Participants
|
19 Participants
n=40 Participants
|
37 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=40 Participants
|
21 Participants
n=40 Participants
|
43 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
|
Type of childbirth
Caesarean section
|
25 Participants
n=40 Participants
|
19 Participants
n=40 Participants
|
44 Participants
n=80 Participants
|
|
Type of childbirth
Natural childbirth
|
15 Participants
n=40 Participants
|
21 Participants
n=40 Participants
|
36 Participants
n=80 Participants
|
|
Gestational age
|
38.43 weeks
STANDARD_DEVIATION 0.93 • n=40 Participants
|
38.53 weeks
STANDARD_DEVIATION 1.20 • n=40 Participants
|
38.48 weeks
STANDARD_DEVIATION 1.07 • n=80 Participants
|
|
Birth weight
|
3280.75 grams
STANDARD_DEVIATION 367.54 • n=40 Participants
|
3412.00 grams
STANDARD_DEVIATION 442.75 • n=40 Participants
|
3346.38 grams
STANDARD_DEVIATION 409.66 • n=80 Participants
|
|
Apgar 5 minutes score
|
8.95 scores on a scale
STANDARD_DEVIATION 0.39 • n=40 Participants
|
8.83 scores on a scale
STANDARD_DEVIATION 0.38 • n=40 Participants
|
8.89 scores on a scale
STANDARD_DEVIATION 0.39 • n=80 Participants
|
|
Positive family history of allergic disease
No
|
21 Participants
n=40 Participants
|
22 Participants
n=40 Participants
|
43 Participants
n=80 Participants
|
|
Positive family history of allergic disease
Yes
|
19 Participants
n=40 Participants
|
18 Participants
n=40 Participants
|
37 Participants
n=80 Participants
|
|
Positive family history of functional gastrointestinal diseases
No
|
37 Participants
n=40 Participants
|
33 Participants
n=40 Participants
|
70 Participants
n=80 Participants
|
|
Positive family history of functional gastrointestinal diseases
Yes
|
3 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
10 Participants
n=80 Participants
|
|
Clinical/surgical history
No prior clinical/surgical events were reported
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
80 Participants
n=80 Participants
|
|
Clinical/surgical history
Prior clinical/surgical events were reported
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Exposure to second-hand tobacco smoke within the home environment
No
|
29 Participants
n=40 Participants
|
29 Participants
n=40 Participants
|
58 Participants
n=80 Participants
|
|
Exposure to second-hand tobacco smoke within the home environment
Yes
|
11 Participants
n=40 Participants
|
11 Participants
n=40 Participants
|
22 Participants
n=80 Participants
|
|
Smoking habits
Mother
|
6 Participants
n=40 Participants
|
4 Participants
n=40 Participants
|
10 Participants
n=80 Participants
|
|
Smoking habits
Mother, Father
|
3 Participants
n=40 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=80 Participants
|
|
Smoking habits
Father
|
5 Participants
n=40 Participants
|
6 Participants
n=40 Participants
|
11 Participants
n=80 Participants
|
|
Smoking habits
No one
|
26 Participants
n=40 Participants
|
29 Participants
n=40 Participants
|
55 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: at 28 days from the baseline (Visit T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they were assigned to at the randomization visit. Patients drop-out were also considered and classified as Treatment success rate = "Missing".
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Visit T5 - Success
|
32 Participants
|
13 Participants
|
|
Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Visit T5 - Missing
|
5 Participants
|
3 Participants
|
|
Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Visit T5 - No Success
|
3 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5
Weekly mean of cries will be defined as the mean number of cries reported in the "Evaluation of behavior" section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too.
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Number of Crying Episodes
Visit T5
|
3.15 number of episodes
Standard Deviation 1.48
|
6.04 number of episodes
Standard Deviation 2.42
|
|
Number of Crying Episodes
Visit T1 - Baseline
|
7.92 number of episodes
Standard Deviation 2.79
|
8.28 number of episodes
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.
Number of infections in respiratory system, gastrointestinal system, urinary tract and skin. An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations".
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Infectious Diseases Incidence
|
0 Number of infections
Standard Deviation 0
|
0 Number of infections
Standard Deviation 0
|
SECONDARY outcome
Timeframe: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5
Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week.
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Bowel Evacuation - Stool Frequency
Visit T5
|
4.34 daily number of bowel evacuations
Standard Deviation 1.45
|
4.64 daily number of bowel evacuations
Standard Deviation 1.23
|
|
Bowel Evacuation - Stool Frequency
Visti T1 - Baseline
|
5.30 daily number of bowel evacuations
Standard Deviation 1.49
|
5.61 daily number of bowel evacuations
Standard Deviation 1.60
|
|
Bowel Evacuation - Stool Frequency
Visit T2
|
5.15 daily number of bowel evacuations
Standard Deviation 1.63
|
5.50 daily number of bowel evacuations
Standard Deviation 1.54
|
|
Bowel Evacuation - Stool Frequency
Visit T3
|
4.92 daily number of bowel evacuations
Standard Deviation 1.53
|
5.35 daily number of bowel evacuations
Standard Deviation 1.45
|
|
Bowel Evacuation - Stool Frequency
Visit T4
|
4.51 daily number of bowel evacuations
Standard Deviation 1.51
|
5.10 daily number of bowel evacuations
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5.
Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows: Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the "Count of Participants" for each group at each visit could be Greater then the "Overall Number of Participants Analyzed"
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Bowel Evacuation - Stool Consistency
T5: Patients with at least one stool of type C
|
0 participants
|
0 participants
|
|
Bowel Evacuation - Stool Consistency
T2: Patients with at least one stool of type F
|
30 participants
|
34 participants
|
|
Bowel Evacuation - Stool Consistency
T2: Patients with at least one stool of type G
|
12 participants
|
20 participants
|
|
Bowel Evacuation - Stool Consistency
T3: Patients with at least one stool of type C
|
0 participants
|
0 participants
|
|
Bowel Evacuation - Stool Consistency
T4: Patients with at least one stool of type C
|
0 participants
|
0 participants
|
|
Bowel Evacuation - Stool Consistency
T4: Patients with at least one stool of type G
|
8 participants
|
5 participants
|
|
Bowel Evacuation - Stool Consistency
T5: Patients with at least one stool of type D
|
17 participants
|
25 participants
|
|
Bowel Evacuation - Stool Consistency
T5: Patients with at least one stool of type F
|
19 participants
|
16 participants
|
|
Bowel Evacuation - Stool Consistency
T2: Patients with at least one stool of type C
|
0 participants
|
1 participants
|
|
Bowel Evacuation - Stool Consistency
T2: Patients with at least one stool of type D
|
14 participants
|
8 participants
|
|
Bowel Evacuation - Stool Consistency
T2: Patients with at least one stool of type E
|
25 participants
|
19 participants
|
|
Bowel Evacuation - Stool Consistency
T1: Patients with at least 1 stool of type C
|
0 participants
|
1 participants
|
|
Bowel Evacuation - Stool Consistency
T1: Patients with at least one stool of type D
|
14 participants
|
10 participants
|
|
Bowel Evacuation - Stool Consistency
T1: Patients with at least one stool of type E
|
21 participants
|
15 participants
|
|
Bowel Evacuation - Stool Consistency
T1: Patients with at least one stool of type F
|
27 participants
|
34 participants
|
|
Bowel Evacuation - Stool Consistency
T1: Patients with at least one stool of type G
|
12 participants
|
21 participants
|
|
Bowel Evacuation - Stool Consistency
T3: Patients with at least one stool of type D
|
16 participants
|
8 participants
|
|
Bowel Evacuation - Stool Consistency
T3: Patients with at least one stool of type E
|
24 participants
|
26 participants
|
|
Bowel Evacuation - Stool Consistency
T3: Patients with at least one stool of type F
|
27 participants
|
30 participants
|
|
Bowel Evacuation - Stool Consistency
T3: Patients with at least one stool of type G
|
8 participants
|
8 participants
|
|
Bowel Evacuation - Stool Consistency
T4: Patients with at least one stool of type D
|
18 participants
|
15 participants
|
|
Bowel Evacuation - Stool Consistency
T4: Patients with at least one stool of type E
|
27 participants
|
30 participants
|
|
Bowel Evacuation - Stool Consistency
T4: Patients with at least one stool of type F
|
23 participants
|
27 participants
|
|
Bowel Evacuation - Stool Consistency
T5: Patients with at least one stool of type E
|
26 participants
|
29 participants
|
|
Bowel Evacuation - Stool Consistency
T5: Patients with at least one stool of type G
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5
The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week. Patients could report more than one mood per day then the sum of the "Count of Participants" for each group at each visit could be greater then the "Overall Number of Participants Analyzed".
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Infant's Mood
T1: Pts. with at least one mood equal to Irritable
|
36 participants
|
36 participants
|
|
Infant's Mood
T2: Pts. with at least one mood equal to Calm
|
14 participants
|
7 participants
|
|
Infant's Mood
T2: Pts. with at least one mood equal to Agitated
|
37 participants
|
32 participants
|
|
Infant's Mood
T3: Pts. with at least one mood equal to Calm
|
28 participants
|
12 participants
|
|
Infant's Mood
T3: Pts. with at least one mood equal to Agitated
|
34 participants
|
33 participants
|
|
Infant's Mood
T3: Pts. with at least one mood equal to Irritable
|
25 participants
|
30 participants
|
|
Infant's Mood
T4: Pts. with at least one mood equal to Calm
|
35 participants
|
15 participants
|
|
Infant's Mood
T4: Pts. with at least one mood equal to Asleep
|
21 participants
|
17 participants
|
|
Infant's Mood
T4: Pts. with at least one mood equal to Agitated
|
32 participants
|
36 participants
|
|
Infant's Mood
T4: Pts. with at least one mood equal to Irritable
|
11 participants
|
28 participants
|
|
Infant's Mood
T5: Pts. with at least one mood equal to Calm
|
35 participants
|
17 participants
|
|
Infant's Mood
T5: Pts. with at least one mood equal to Asleep
|
27 participants
|
23 participants
|
|
Infant's Mood
T5: Pts. with at least one mood equal to Agitated
|
9 participants
|
34 participants
|
|
Infant's Mood
T5: Pts. with at least one mood equal to Irritable
|
5 participants
|
20 participants
|
|
Infant's Mood
T1: Pts with at least one mood equal to Calm
|
4 participants
|
5 participants
|
|
Infant's Mood
T1: Pts. with at least one mood equal to Asleep
|
5 participants
|
6 participants
|
|
Infant's Mood
T1: Pts. with at least one mood equal to Agitated
|
38 participants
|
25 participants
|
|
Infant's Mood
T2: Pts. with at least one mood equal to Asleep
|
11 participants
|
8 participants
|
|
Infant's Mood
T2: Pts. with at least one mood equal to Irritable
|
33 participants
|
34 participants
|
|
Infant's Mood
T3: Pts. with at least one mood equal to Asleep
|
12 participants
|
8 participants
|
SECONDARY outcome
Timeframe: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5
Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Infant's Sleep
Visit T1 - baseline
|
678.14 minutes
Standard Deviation 96.13
|
693.62 minutes
Standard Deviation 121.79
|
|
Infant's Sleep
Visit T2
|
687.47 minutes
Standard Deviation 113.41
|
696.68 minutes
Standard Deviation 121
|
|
Infant's Sleep
Visit T3
|
722.37 minutes
Standard Deviation 116.30
|
711.99 minutes
Standard Deviation 128.87
|
|
Infant's Sleep
Visit T4
|
725.76 minutes
Standard Deviation 112.54
|
725.14 minutes
Standard Deviation 131.74
|
|
Infant's Sleep
Visit T5
|
713.20 minutes
Standard Deviation 98.97
|
738.61 minutes
Standard Deviation 141.58
|
SECONDARY outcome
Timeframe: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.
Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Infant's Temper
Visit T1 - Baseline
|
158.82 minutes
Standard Deviation 36.31
|
138 minutes
Standard Deviation 34.71
|
|
Infant's Temper
Visit T2
|
118.61 minutes
Standard Deviation 45.59
|
117.24 minutes
Standard Deviation 58.32
|
|
Infant's Temper
Visit T3
|
89.48 minutes
Standard Deviation 47.96
|
84.33 minutes
Standard Deviation 46.76
|
|
Infant's Temper
Visit T4
|
71.71 minutes
Standard Deviation 54.79
|
84.89 minutes
Standard Deviation 58.04
|
|
Infant's Temper
Visit T5
|
36.79 minutes
Standard Deviation 42.45
|
72.96 minutes
Standard Deviation 40.22
|
SECONDARY outcome
Timeframe: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)Population: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.
Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=40 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Infant's Feeding
Visit T1 - Baseline
|
187.72 minutes
Standard Deviation 35.95
|
177.72 minutes
Standard Deviation 34.66
|
|
Infant's Feeding
Visit T2
|
186.13 minutes
Standard Deviation 63.37
|
188.98 minutes
Standard Deviation 32.75
|
|
Infant's Feeding
Visit T3
|
179.80 minutes
Standard Deviation 55.16
|
185.98 minutes
Standard Deviation 30.98
|
|
Infant's Feeding
Visit T4
|
180.31 minutes
Standard Deviation 47.85
|
182.22 minutes
Standard Deviation 28.70
|
|
Infant's Feeding
Visit T5
|
176.47 minutes
Standard Deviation 38.55
|
182.26 minutes
Standard Deviation 27.20
|
SECONDARY outcome
Timeframe: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)Population: The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5
Evaluation of calprotectin levels in fecal samples
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=32 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=30 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Calprotectin
Visit T1 - Baseline
|
667.76 mM/Kg
Standard Deviation 162.06
|
658.47 mM/Kg
Standard Deviation 112.61
|
|
Calprotectin
Visit T5
|
802.64 mM/Kg
Standard Deviation 131.33
|
915.41 mM/Kg
Standard Deviation 106.47
|
SECONDARY outcome
Timeframe: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)Population: The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5
Evaluation of Beta-defensin type 2 levels in fecal samples
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=32 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=30 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Beta-defensin Type 2
Visit T1 - baseline
|
73.50 ng/g
Standard Deviation 10.92
|
69.41 ng/g
Standard Deviation 7.03
|
|
Beta-defensin Type 2
Visit T5
|
166.34 ng/g
Standard Deviation 43.79
|
127.97 ng/g
Standard Deviation 35.41
|
SECONDARY outcome
Timeframe: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)Population: The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5
Evaluation of LL37 peptide levels in fecal samples
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=32 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=30 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
LL37 Peptide
Visit T1 - Baseline
|
5.50 ng/g
Standard Deviation 0.82
|
5.37 ng/g
Standard Deviation 0.83
|
|
LL37 Peptide
Visit T5
|
7.65 ng/g
Standard Deviation 1.15
|
6.07 ng/g
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)Population: The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5
Evaluation of Butyrate levels in fecal samples
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=32 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=30 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Short Chain Fatty Acids - Butyrate
Visit T1 - Baseline
|
0.19 mM/Kg
Standard Deviation 0.14
|
0.17 mM/Kg
Standard Deviation 0.16
|
|
Short Chain Fatty Acids - Butyrate
Visit T5
|
0.63 mM/Kg
Standard Deviation 0.49
|
0.32 mM/Kg
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)Population: The analysis Population includes all the participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5
Secretory immunoglobulin A (SIgA) levels in fecal samples
Outcome measures
| Measure |
Bifidobacterium BB-12®
n=32 Participants
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=30 Participants
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Secretory Immunoglobulin A (SIgA)
Visit T1 - Baseline
|
84.79 microg/g
Standard Deviation 21.71
|
86.55 microg/g
Standard Deviation 12.13
|
|
Secretory Immunoglobulin A (SIgA)
Visit T5
|
250.65 microg/g
Standard Deviation 37.95
|
192.01 microg/g
Standard Deviation 27.12
|
Adverse Events
Bifidobacterium BB-12®
Placebo
Serious adverse events
| Measure |
Bifidobacterium BB-12®
n=40 participants at risk
patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Bifidobacterium, BB-12® (Bifidolactis Infant)
|
Placebo
n=40 participants at risk
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.5%
1/40 • Number of events 1 • 5 weeks starting from the patient enrollment
|
0.00%
0/40 • 5 weeks starting from the patient enrollment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place