Open-label, prospective, multicenter study to assess efficacy and safety of Lactacol/Lactazak®, a food supplement in intestinal colic and bloating
Not Applicable
Completed
- Conditions
- Intestinal colic and bloatingDigestive System
- Registration Number
- ISRCTN17581847
- Lead Sponsor
- Pharmunion LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
1. Unwillingness to provide signed Informed Consent for data collecting
2. Patients participating in other trials
3. Allergy to any of the product ingredients
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Baby's crying due to colic (number of babies crying episodes during 24 h) measured by reviewing patient’s diary daily<br>2. Bloating measured using (3-point Likert scale: 1 – None, 2 – Moderatly, 3 – Intense) recorded in patient’s diary daily<br>
- Secondary Outcome Measures
Name Time Method To assess the effectiveness of the product administration by the responses to below questions during the study period:<br>1. How many hours in total does your child sleep per 24-h period?”<br>2. How many hours in total do you (as caregiver) sleep per 24-h period?”<br>3. How often does your child usually wake during the night?”<br><br>To assess the safety of the product administration in terms of the following:<br>1. AE occurrence when reported by the caregiver<br>2. Withdrawals due to lack of tolerability when reported by the caregiver