Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
None listed
Sponsors
Global Generics India Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: from birth to 5 months of age 2. Diagnosed with infantile colic using Rome IV Criteria (Infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week) and recommended with nutritional supplementation of Lactobacillus reuteri for infantile colic by the treating physician 3. Full term infant, i.e. gestational age between 37 and 42 weeks 4. Breast fed, either exclusively or predominantly, i.e. more than 50% time 5. Birth weight >2500g 6. Apgar score >= 8 at 5 minutes at birth 7. Written informed consent from parents to share data as per protocol and adhere to routine follow up visits as required by treating physician 8. Parent(s) willing to maintain same infant feeding mode throughout study period 9. Parent(s) willingness and ability to fill in diary and questionnaires
Exclusion criteria
Exclusion criteria: 1. Significant co-existing illness or major medical problem, which in opinion of treating physician does not make patient suitable for participation in study 2. Any other gastrointestinal disorder 3. Failure to thrive 4. Use of antibiotics two weeks before enrolment and throughout the intervention period, for both infant and mother 5. Use of probiotics two weeks before enrolment and throughout the intervention period, for both infant (infant formula and/or supplementation) and mother 6. Use of acid suppressive therapy two weeks before enrolment and throughout the intervention period. 7. Infant receiving solid foods, such as cereals, mashed fruits or vegetable puree 8. Participation in any other interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in daily average crying time during study period compared to baseline 2. Treatment success - defined as the percentage of children achieving a reduction in the daily average crying time 50% during the study period Timepoint: All patients will be followed up as per routine clinical practice, however the data will be recorded at following time points: baseline i.e. day 0 (Visit 1) day 3 (Visit 2) day 7(Visit 3) day 14 (Visit 4) day 21(Visit 5) and day 28(Visit 6) of study period. At Day 7 (Visit 3) Day 21 (Visit 5) and Day 28 (Visit 6) the data post physical examination at clinic and the diary card will be recorded | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fussiness on a Fussiness Rating Scale (FRS) compared to base line 2. Parental perception of colic severity during the study period on a 0 to 10 Visual Analogue Scale (VAS Scale) compared to baseline 3. Maternal depression during the study period (EPDS) compared to baseline 4. Assessment of safety and tolerability of L.reuteri based on parent reported or investigator observed adverse events Timepoint: All patients will be followed up as per routine clinical practice, however the data will be recorded at following time points: baseline i.e. day 0 (Visit 1) day 3 (Visit 2) day 7(Visit 3) day 14 (Visit 4) day 21(Visit 5) and day 28(Visit 6) of study period. At Day 7 (Visit 3) Day 21 (Visit 5) and Day 28 (Visit 6) the data post physical examination at clinic and the diary card will be recorded | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt. Ltd.
Outcome results
None listed