Infantile Colic
Conditions
Brief summary
Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.
Detailed description
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby). Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.
Interventions
Oral daily treatment for four weeks
DIETARY_SUPPLEMENTVivatlac Baby
Oral daily treatment for four weeks
Sponsors
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 6 Weeks
Healthy volunteers
No
Inclusion criteria
* diagnosed for infantile colic according to Wessel's criteria
Exclusion criteria
* previous treatment with probiotic or synbiotic * previous treatment with antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | 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. |
| Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | 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. |
| Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | 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. |
Countries
Poland
Participant flow
Recruitment details
915 patients were assessed for eligibility.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| Vivatlac Baby 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 | 54 |
| Total | 87 |
Baseline characteristics
| Characteristic | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Age, Continuous | 25.0 days STANDARD_DEVIATION 1.9 | 26.0 days STANDARD_DEVIATION 1.8 | 25.6 days STANDARD_DEVIATION 1.9 |
| Birthweight | 3480 g STANDARD_DEVIATION 412 | 3500 g STANDARD_DEVIATION 404 | 3492 g STANDARD_DEVIATION 347 |
| Days of crying | 18.2 days STANDARD_DEVIATION 1.7 | 18.3 days STANDARD_DEVIATION 2.1 | 18.2 days STANDARD_DEVIATION 1.6 |
| Duration of evenning crying | 2.7 h/day STANDARD_DEVIATION 0.5 | 2.8 h/day STANDARD_DEVIATION 0.7 | 2.8 h/day STANDARD_DEVIATION 0.5 |
| Feeding Breast feeding | 22 Participants | 27 Participants | 49 Participants |
| Feeding Formula feeding | 11 Participants | 17 Participants | 28 Participants |
| Feeding Mixed feeding | 0 Participants | 10 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Poland | 33 participants | 54 participants | 87 participants |
| Sex: Female, Male Female | 18 Participants | 29 Participants | 47 Participants |
| Sex: Female, Male Male | 15 Participants | 25 Participants | 40 Participants |
| Type of delivery Caesarean | 9 Participants | 15 Participants | 24 Participants |
| Type of delivery Normal | 24 Participants | 39 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 54 |
| other Total, other adverse events | 0 / 33 | 0 / 54 |
| serious Total, serious adverse events | 0 / 33 | 0 / 54 |
Outcome results
Primary
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
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.
Time frame: Three weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simethicone Solution | Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | 13 Participants |
| Vivatlac Baby | Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | 46 Participants |
p-value: 0.0001Fisher Exact
Primary
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
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.
Time frame: Three weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simethicone Solution | Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | 14 Participants |
| Vivatlac Baby | Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | 27 Participants |
p-value: 0.4852Fisher Exact
Primary
Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
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.
Time frame: Three weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simethicone Solution | Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | 6 Participants |
| Vivatlac Baby | Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | 39 Participants |
p-value: <0.0001Fisher Exact