Lactose Intolerance in children Digestive System
Conditions
Interventions
This non-interventional study is conducted in Bulgaria in routine clinical practice by GPs or Pediatricians. Data will be collected prospectively. Lactacol will be administered in accordance with appr
Sponsors
Pharmunion LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pediatric population : 7 months – 7 years. 2. Established diagnosis: Lactose Intolerance with: in terms of frequency, there should be at least one baseline symptom occurring “often” or “always,” and no symptom notated with “0” (“never”) In terms of severity, there should be at least one baseline symptom with a severity score of 2 (Moderate) or higher and no symptom notated with “0” (“no symptoms”). 3. Signed Informed Consent for data collecting.
Exclusion criteria
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 |
|---|---|
| Bloating measured daily from Day 0 to Day 14 and at Day 21 using a 5-point frequency score (Never = 0, Rarely = 1, Sometimes = 2, Often = 3, Always = 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abdominal pain measured using a 5-point frequency score (Never = 0, Rarely = 1, Sometimes = 2, Often = 3, Always = 4) and a 5-point severity score (No symptoms = 0, Mild = 1, Moderate = 2, Severe = 3, Very severe = 4) at Day 0, Day 14 and Day 21. 2. Diarrhoea measured using a 5-point frequency score (Never = 0, Rarely = 1, Sometimes = 2, Often = 3, Always = 4) and a 5-point severity score at Day 0, Day 14 and Day 21. 3. Flatulence measured using a 5-point frequency score (Never = 0, Rarely = 1, Sometimes = 2, Often = 3, Always = 4) and a 5-point severity score at Day 0, Day 14 and Day 21. 4. Nausea measured using a 5-point frequency score (Never = 0, Rarely = 1, Sometimes = 2, Often = 3, Always = 4) and 5-point severity score at Day 0, Day 14 and Day 21. 5. Discomfort measured using a 5-point frequency score (Never = 0, Rarely = 1, Sometimes = 2, Often = 3, Always = 4) and 5-point severity score at Day 0, Day 14 and Day 21. 6. Quality of Life (QoL) measured using the Visual Analogue Scale (VAS) at Day 0 and Day 14. 7. Investigator’s Final Evaluation assessed at Day 21. 8. Adverse events recorded during the study period (Day 0 to Day 21). 9. Participant withdrawals due to lack of tolerability recorded during the study period (Day 0 to Day 21). | — |
Countries
Bulgaria
Contacts
Public ContactAlina Iordache
Outcome results
None listed