Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Study Overview
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Brief Summary
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Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

Detailed Description
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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.

Official Title
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Effects of Simethicone and Vivatlac Baby in Infantile Colic

Conditions
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Infantile Colic

Intervention / Treatment
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* Drug: Simethicone Solution
* Dietary Supplement: Vivatlac Baby


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed for infantile colic according to Wessel's criteria Exclusion Criteria: previous treatment with probiotic or synbiotic previous treatment with antibiotics

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simethicone Solution<br>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. | Drug: Simethicone Solution<br>* Oral daily treatment for four weeks<br>* Other names: Simethicone;|
| Experimental: Vivatlac Baby<br>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. | Dietary Supplement: Vivatlac Baby<br>* Oral daily treatment for four weeks<br>* Other names: Multistrain Synbiotic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three weeks | 
| 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. | Three weeks | 
| 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. | Three weeks |