Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

Not Applicable

• Conditions: Infantile Colic
• Interventions: Drug: Simethicone Solution; Dietary Supplement: Multilac Baby

• Registration Number: NCT04666324
• Lead Sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-14
• Primary Completion: 2021-06
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria

• previous treatment with probiotic or synbiotic
• previous treatment with antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simethicone Solution	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.
Multilac Baby	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.

Primary Outcome Measures

Name	Time	Method
Change of days of crying	Three weeks	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.
Change of average duration of evening crying	Three weeks	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.
Change of fecal calprotectin values	1-30 days	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.

Trial Locations

Locations (2)

GP Clinic "Pro Familia"; 🇵🇱 Koziegłowy, Poland

GP Clinic "Panaceum"; 🇵🇱 Brody, Poland