Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Status and phase: Completed; Phase 2

Conditions: Infantile Colic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04487834

Kalisz 2020-01

Details and patient eligibility

About

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby 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 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.

Enrollment: 87 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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87 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

Vivatlac Baby

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vivatlac Baby