An interventional study of Simethicone Solution and Multilac Baby in Infantile Colic, sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz. Status unknown at 2 sites in Poland. Open to participants aged 3 Weeks to 6 Weeks. Per ClinicalTrials.gov, last updated 2020-12-14.
Sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Not applicable, Interventional, and Treatment
Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels 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 Multilac Baby). Multilac 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. Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland), a quantitative immunoassay.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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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 (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.
Dietary Supplement: Multilac Baby
Oral daily treatment for four weeks
Also known as: Control Group
Oral daily treatment for four weeks
Also known as: Treatment Group
Change of days of crying
Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success will be determined by calculation the percentage of patients for whom the measurement will be 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
Change of average duration of evening crying
Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success will be determined by calculation the percentage of patients for whom the measurement will be 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
Change of fecal calprotectin values
BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland). It is a quantitative determination of fecal calprotectin through a sandwich immunoassay. Treatment success will be determined by calculation the percentage of patients for whom the measurement will be reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Time frame: 1-30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz