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Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

Primary Purpose

Infantile Colic

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Simethicone Solution
Multilac Baby
Sponsored by
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic

Eligibility Criteria

3 Weeks - 6 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • GP Clinic "Panaceum"
  • GP Clinic "Pro Familia"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Simethicone Solution

Multilac Baby

Arm 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 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
December 7, 2020
Sponsor
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
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1. Study Identification

Unique Protocol Identification Number
NCT04666324
Brief Title
Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies
Official Title
Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simethicone Solution
Arm Type
Active Comparator
Arm 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.
Arm Title
Multilac Baby
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Simethicone Solution
Other Intervention Name(s)
Control Group
Intervention Description
Oral daily treatment for four weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Multilac Baby
Other Intervention Name(s)
Treatment Group
Intervention Description
Oral daily treatment for four weeks
Primary Outcome Measure Information:
Title
Change of days of crying
Description
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.
Time Frame
Three weeks
Title
Change of average duration of evening crying
Description
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.
Time Frame
Three weeks
Title
Change of fecal calprotectin values
Description
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.
Time Frame
1-30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed for infantile colic according to Wessel's criteria Exclusion Criteria: previous treatment with probiotic or synbiotic previous treatment with antibiotics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna i Krauss, Prof.
Phone
+48 88 33 89
Ext
788
Email
hjk12@pczta.fm
First Name & Middle Initial & Last Name or Official Title & Degree
Jacek Piatek, Prof.
Email
drpiatek@interia.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Krauss, Prof.
Organizational Affiliation
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Official's Role
Principal Investigator
Facility Information:
Facility Name
GP Clinic "Panaceum"
City
Brody
ZIP/Postal Code
27-230
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Maciukajc, Dr.
Email
marek.maciukajc@gmail.com
First Name & Middle Initial & Last Name & Degree
Jacek Piatek, Prof.
Email
drpiatek@interia.eu
Facility Name
GP Clinic "Pro Familia"
City
Koziegłowy
ZIP/Postal Code
62028
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Krauss, Prof.
Email
hjk12@pczta.fm
First Name & Middle Initial & Last Name & Degree
Jacek Piatek, Prof.
Email
drpiatek@interia.eu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32403297
Citation
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):3332. doi: 10.3390/ijerph17093332.
Results Reference
result
PubMed Identifier
36245729
Citation
Sommermeyer H, Bernatek M, Pszczola M, Krauss H, Piatek J. Supporting the diagnosis of infantile colic by a point of care measurement of fecal calprotectin. Front Pediatr. 2022 Sep 29;10:978545. doi: 10.3389/fped.2022.978545. eCollection 2022.
Results Reference
derived
PubMed Identifier
35208884
Citation
Bernatek M, Piatek J, Pszczola M, Krauss H, Antczak J, Maciukajc P, Sommermeyer H. Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study. Microorganisms. 2022 Feb 12;10(2):430. doi: 10.3390/microorganisms10020430.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246756/
Description
Publication

Learn more about this trial

Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

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