Infantile Colic
Conditions
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.
Interventions
Oral daily treatment for four weeks
DIETARY_SUPPLEMENTMultilac Baby
Oral daily treatment for four weeks
Sponsors
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 6 Weeks
Healthy volunteers
No
Inclusion criteria
* diagnosed for infantile colic according to Wessel's criteria
Exclusion criteria
* previous treatment with probiotic or synbiotic * previous treatment with antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of days of crying | 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 | 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 | 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. |
Countries
Poland
Contacts
Primary ContactHanna i Krauss, Prof.
Backup ContactJacek Piatek, Prof.
Outcome results
None listed