Comparison · NCT04487834-e3997cc2
Simethicone Solution vs Vivatlac Baby: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Simethicone Solution vs Vivatlac Baby: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline. Trial comparisons, record NCT04487834-e3997cc2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04487834-e3997cc2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.182 | 0.0861 | 0.344 | wilson | |
| Risk in group 2 | 0.722 | 0.591 | 0.824 | wilson | |
| Risk difference, group 1 minus group 2 | -0.54 | -0.68 | -0.332 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.252 | 0.12 | 0.529 | log | |
| Odds ratio, group 1 over group 2 | 0.0855 | 0.0294 | 0.248 | log | |
| Number needed to treat, for one fewer participant with the outcome on Simethicone Solution than on Vivatlac Baby | 1.85 | 1.47 | 3.01 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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 | 6 | 33 | OG000 |
| Group 2 | 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 | 39 | 54 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
- Description
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
- Population
Source ClinicalTrials.gov
Trial
- Title
- Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
- NCT number
- NCT04487834
- Phases
- PHASE2
- Conditions
- Infantile Colic
- Interventions
- Simethicone Solution, Vivatlac Baby
- Lead sponsor
- The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
- Results first posted
- 2023-11-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04487834?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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