Intestinal colic and bloating Digestive System
Conditions
Interventions
This non-interventional study is conducted in Bulgaria in routine clinical practice by GPs. Data is to be collected prospectively. Lactacol/Lactazak® will be administered in accordance with the approv
Sponsors
Pharmunion LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pediatric population 0-4 months 2. Established diagnosis: FGIDs (intestinal colic and bloating) 3. Signed Informed Consent for data collecting
Exclusion criteria
Exclusion criteria: 1. Unwillingness to provide signed Informed Consent for data collecting 2. Patients participating in other trials 3. Allergy to any of the product ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Baby's crying due to colic (number of babies crying episodes during 24 h) measured by reviewing patient’s diary daily 2. Bloating measured using (3-point Likert scale: 1 – None, 2 – Moderate, 3 – Intense) recorded in patient’s diary daily | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of the product administration by the responses to below questions during the study period: 1. “How many hours in total does your child sleep per 24-h period?” 2. “How many hours in total do you (as caregiver) sleep per 24-h period?” 3. “How often does your child usually wake during the night?” To assess the safety of the product administration in terms of the following: 1. AE occurrence when reported by the caregiver 2. Withdrawals due to lack of tolerability when reported by the caregiver | — |
Countries
Bulgaria
Contacts
Public ContactAlina Iordache
Outcome results
None listed