NCT04666324

Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Academic / Other
• Sex: All
• Age: 3 Weeks – 6 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DRUG	Simethicone Solution	Oral daily treatment for four weeks
DIETARY_SUPPLEMENT	Multilac Baby	Oral daily treatment for four weeks

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2020-12-14
• Last updated: 2020-12-14

Locations

2 sites across 1 country: Poland