MedDataX Logo

Trial Outcomes & Findings for Effects of Vivatlac Baby on Crying Behavior of Colicky Babies (NCT NCT04487834)

NCT ID: NCT04487834

Last Updated: 2023-11-22

Results Overview

Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

Three weeks

Results posted on

2023-11-22

Participant Flow

915 patients were assessed for eligibility.

828 patients were excluded before randomization (parents of 704 patients declined to participate, 123 patients were diagnosed non-colic, 1 patient was excluded because of antibiotic treatment). 87 patients were randomized (33 to the Simethicone arm and 54 to the multi-strain synbiotic arm)

Participant milestones

Participant milestones
Measure
Simethicone Solution
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion. Simethicone Solution: Oral daily treatment for four weeks
Multilac Baby
Treatment with one stick pack of the multi-strain synbiotic (Multilac® Baby, Vivatrex GmbH, Aachen, Germany) per day for four weeks. Each stick pack of Multilac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides. Multilac Baby: Oral daily treatment for four weeks
Overall Study
STARTED
33
54
Overall Study
COMPLETED
33
54
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Simethicone Solution
n=33 Participants
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion. Simethicone Solution: Oral daily treatment for four weeks
Vivatlac Baby
n=54 Participants
Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides. Vivatlac Baby: Oral daily treatment for four weeks
Total
n=87 Participants
Total of all reporting groups
Age, Continuous
25.0 days
STANDARD_DEVIATION 1.9 • n=33 Participants
26.0 days
STANDARD_DEVIATION 1.8 • n=54 Participants
25.6 days
STANDARD_DEVIATION 1.9 • n=87 Participants
Sex: Female, Male
Female
18 Participants
n=33 Participants
29 Participants
n=54 Participants
47 Participants
n=87 Participants
Sex: Female, Male
Male
15 Participants
n=33 Participants
25 Participants
n=54 Participants
40 Participants
n=87 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Poland
33 participants
n=33 Participants
54 participants
n=54 Participants
87 participants
n=87 Participants
Type of delivery
Normal
24 Participants
n=33 Participants
39 Participants
n=54 Participants
63 Participants
n=87 Participants
Type of delivery
Caesarean
9 Participants
n=33 Participants
15 Participants
n=54 Participants
24 Participants
n=87 Participants
Birthweight
3480 g
STANDARD_DEVIATION 412 • n=33 Participants
3500 g
STANDARD_DEVIATION 404 • n=54 Participants
3492 g
STANDARD_DEVIATION 347 • n=87 Participants
Feeding
Breast feeding
22 Participants
n=33 Participants
27 Participants
n=54 Participants
49 Participants
n=87 Participants
Feeding
Formula feeding
11 Participants
n=33 Participants
17 Participants
n=54 Participants
28 Participants
n=87 Participants
Feeding
Mixed feeding
0 Participants
n=33 Participants
10 Participants
n=54 Participants
10 Participants
n=87 Participants
Days of crying
18.2 days
STANDARD_DEVIATION 1.7 • n=33 Participants
18.3 days
STANDARD_DEVIATION 2.1 • n=54 Participants
18.2 days
STANDARD_DEVIATION 1.6 • n=87 Participants
Duration of evenning crying
2.7 h/day
STANDARD_DEVIATION 0.5 • n=33 Participants
2.8 h/day
STANDARD_DEVIATION 0.7 • n=54 Participants
2.8 h/day
STANDARD_DEVIATION 0.5 • n=87 Participants

PRIMARY outcome

Timeframe: Three weeks

Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Outcome measures

Outcome measures
Measure
Simethicone Solution
n=33 Participants
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion. Simethicone Solution: Oral daily treatment for four weeks
Vivatlac Baby
n=54 Participants
Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides. Vivatlac Baby: Oral daily treatment for four weeks
Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
6 Participants
39 Participants

PRIMARY outcome

Timeframe: Three weeks

Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Outcome measures

Outcome measures
Measure
Simethicone Solution
n=33 Participants
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion. Simethicone Solution: Oral daily treatment for four weeks
Vivatlac Baby
n=54 Participants
Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides. Vivatlac Baby: Oral daily treatment for four weeks
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
13 Participants
46 Participants

PRIMARY outcome

Timeframe: Three weeks

Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Outcome measures

Outcome measures
Measure
Simethicone Solution
n=33 Participants
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion. Simethicone Solution: Oral daily treatment for four weeks
Vivatlac Baby
n=54 Participants
Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides. Vivatlac Baby: Oral daily treatment for four weeks
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
14 Participants
27 Participants

Adverse Events

Simethicone Solution

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Multilac Baby

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacek Piatek

Calisia University, Kalisz, Poland

Phone: +48883389788

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place