A Phase 2 interventional study of Simethicone Solution and Vivatlac Baby in Infantile Colic, sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz. Completed at 2 sites in Poland. Open to participants aged 3 Weeks to 6 Weeks. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Phase 2, Interventional, and Treatment
Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.
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.
Exclusion Criteria:
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
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
Oral daily treatment for four weeks
Also known as: Simethicone
Oral daily treatment for four weeks
Also known as: Multistrain Synbiotic
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
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
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
915 patients were assessed for eligibility.
| Milestone | Simethicone Solution | Multilac Baby |
|---|---|---|
| Started | 33 | 54 |
| Completed | 33 | 54 |
| Not completed | 0 | 0 |
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.
| Participants | Simethicone Solution | Vivatlac Baby |
|---|---|---|
| Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | 6 | 39 |
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.
| Participants | Simethicone Solution | Vivatlac Baby |
|---|---|---|
| Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | 13 | 46 |
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.
| Participants | Simethicone Solution | Vivatlac Baby |
|---|---|---|
| Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | 14 | 27 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simethicone Solution | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Multilac Baby | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Age, Continuous(days) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Mean | 25.0 ± 1.9 | 26.0 ± 1.8 | 25.6 ± 1.9 |
| Sex: Female, Male(Participants) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Female | 18 | 29 | 47 |
| Male | 15 | 25 | 40 |
| Race and Ethnicity Not Collected(Participants) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Poland | 33 | 54 | 87 |
| Type of delivery(Participants) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Normal | 24 | 39 | 63 |
| Caesarean | 9 | 15 | 24 |
| Birthweight(g) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Mean | 3480 ± 412 | 3500 ± 404 | 3492 ± 347 |
| Feeding(Participants) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Breast feeding | 22 | 27 | 49 |
| Formula feeding | 11 | 17 | 28 |
| Mixed feeding | 0 | 10 | 10 |
| Days of crying(days) | Simethicone Solution | Vivatlac Baby | Total |
|---|---|---|---|
| Mean | 18.2 ± 1.7 | 18.3 ± 2.1 | 18.2 ± 1.6 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz