Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Status: Unknown

Conditions: Infantile Colic

Treatments: Drug: Simethicone Solution; Dietary Supplement: Multilac Baby

Study type: Interventional

Funder types: Other

Identifiers

NCT04666324

Kalisz 2020-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 6 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed for infantile colic according to Wessel's criteria

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Simethicone Solution

Active Comparator group

Description:

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.

Treatment:

Drug: Simethicone Solution

Multilac Baby

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Multilac Baby