NCT04666324

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

Status unknown NA Last updated 7 December 2020

What this trial tests

NA trial testing Simethicone Solution in Infantile Colic in 100 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
1 June 2021

1 September 2021

Quick facts

Lead sponsor	The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 December 2020
Primary completion	1 June 2021
Estimated completion	1 September 2021
Sites	2 locations across Poland

Drugs / interventions tested

• Simethicone Solution — full drug profile →
• Multilac Baby

Conditions studied

• Infantile Colic — all drugs for Infantile Colic →

Sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Who can join

Adults 3 Weeks to 6 Weeks, any sex, with Infantile Colic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change of days of crying
  Time frame: 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
  Time frame: 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
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Supporting the diagnosis of infantile colic by a point of care measurement of fecal calprotectin.
   Sommermeyer H, Bernatek M, Pszczola M, Krauss H, et al · · 2022 · cited 4× · PMID 36245729 · DOI 10.3389/fped.2022.978545
2. Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study.
   Bernatek M, Piątek J, Pszczola M, Krauss H, et al · · 2022 · cited 1× · PMID 35208884 · DOI 10.3390/microorganisms10020430