Trials Sponsors Conditions Drugs Pricing

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (3)

Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Three weeks
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Three weeks
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Three weeks

Study Arms (2)

Simethicone Solution

ACTIVE COMPARATOR

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.

Drug: Simethicone Solution

Vivatlac Baby

EXPERIMENTAL

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.

Dietary Supplement: Vivatlac Baby

Interventions

Simethicone SolutionDrug

Oral daily treatment for four weeks

Also known as: Simethicone

Simethicone Solution

Vivatlac BabyDietary supplement

Oral daily treatment for four weeks

Also known as: Multistrain Synbiotic

Eligibility Criteria

Age3 Weeks - 6 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

diagnosed for infantile colic according to Wessel's criteria

You may not qualify if:

Sponsors & Collaborators

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Otherlead

Study Sites (2)

GP Practice Pro Familia

Koziegłowy, 62028, Poland

Medical University in Poznań

Poznan, 61701, Poland

Related Publications (2)

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.
PMID: 32403297BACKGROUND
Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.
PMID: 33765904DERIVED

MeSH Terms

Conditions

Colic

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental Materials

Limitations and Caveats

A limitation of the study is the use of parental diaries to measure infants' crying behavior. Using paper diaries is not without problems. Nevertheless, it has been shown that paper diary recordings of common infant behavior can provide reasonably good estimates of durations, while behavioral frequencies may be underestimated. Another major limitation of the study is that medication was not blinded.

Results Point of Contact

Title: Jacek Piatek
Organization: Calisia University, Kalisz, Poland

Study Officials

Hanna Krauss, Prof.
University of Applied Sciences in Kalisz, Poland
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

87 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

April 16, 2020

Actual (reported)

Primary Completion

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

Simethicone Solution

Vivatlac Baby

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations