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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simethicone Solution | Active Comparator | 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. |
|
| Vivatlac Baby | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simethicone Solution | Drug | Oral daily treatment for four weeks |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Krauss, Prof. | University of Applied Sciences in Kalisz, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GP Practice Pro Familia | Koziegłowy | 62028 | Poland | |||
| Medical University in Poznań |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32403297 | Background | Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332. | |
| 33765904 | Derived | Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26. |
| Label | URL |
|---|---|
| In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters | View source |
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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)
915 patients were assessed for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in days at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Three weeks |
|
4 weeks
Adverse events were collected by a non-systematic assessment: Every event considered by parents of babies to be an adverse event was reported as an event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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A limitation of the study is the use of parental diaries to measure infants' crying behavior. Using paper diaries is not without problems. Nevertheless, it has been shown that paper diary recordings of common infant behavior can provide reasonably good estimates of durations, while behavioral frequencies may be underestimated. Another major limitation of the study is that medication was not blinded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacek Piatek | Calisia University, Kalisz, Poland | +48883389788 | drpiatek@interia.eu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Effects of Simethicone and Multilac Baby in Infantile Colic | Mar 2, 2020 | Jul 22, 2020 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Annex Patient Assessment Sheet Day 0 | Mar 2, 2020 | Jul 22, 2020 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Annex 24 Hours Parental Diary Form | Mar 2, 2020 | Jul 22, 2020 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2020 | Jul 22, 2020 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D012841 | Simethicone |
| ID | Term |
|---|---|
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
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| Vivatlac Baby | Dietary Supplement | Oral daily treatment for four weeks |
|
|
| Poznan |
| 61701 |
| Poland |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of delivery | (normal/caesarean) | Count of Participants | Participants |
|
| Birthweight | Birthweight in g | Mean | Standard Deviation | g |
|
| Feeding | breast/formula/mixed | Count of Participants | Participants |
|
| Days of crying | Days of crying last 3 weeks before start of treatment | Mean | Standard Deviation | days |
|
| Duration of evenning crying | Duration of evenning crying in three weeks before start of treatment | Mean | Standard Deviation | h/day |
|
| 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 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Three weeks |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | Three weeks |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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 | 0 | 54 | 0 | 54 | 0 | 54 |
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| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Mixed feeding |
|