Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

Infantile Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04666324
• Other study ID #: Kalisz 2020-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: September 2021

Study information

• Verified date: December 2020
• Source: The President Stanislaw Wojciechowski State University of Applied Sciences in Kalisz
• Contact: Hanna i Krauss, Prof.
• Phone: +48 88 33 89
• Email: hjk12[@]pczta.fm
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

Inclusion Criteria:

• diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria:

• previous treatment with probiotic or synbiotic

• previous treatment with antibiotics

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Drug:
• Simethicone Solution
Oral daily treatment for four weeks

Dietary Supplement:
• Multilac Baby
Oral daily treatment for four weeks

Locations

Country	Name	City	State
Poland	GP Clinic "Panaceum"	Brody
Poland	GP Clinic "Pro Familia"	Kozieglowy

Sponsors (1)

Lead Sponsor	Collaborator
The President Stanislaw Wojciechowski State University of Applied Sciences in Kalisz

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9). pii — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of days of crying	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.	Three weeks
Primary	Change of average duration of evening crying	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.	Three weeks
Primary	Change of fecal calprotectin values	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.	1-30 days

External Links

•   Publication