Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Aristo Pharmaceuticals Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female infants, aged less than 5 months, and diagnosed with infantile colic using Rome IV Criteria - Infant has cried for 3 or more hours per day, during 3 or more days in the preceding week and recommended with nutritional supplementation of either Bifidobacterium lactis BB-12 or SOC as per the investigator s choice with no probiotic 2. Full-term infant, i.e. gestational age between 37 and 42 weeks 3. Birth weight more than 2500g 4. Breastfed, either exclusively or predominantly, i.e. more than 50 percentage times 5. Parent(s) who maintained the same infant feeding mode throughout the study treatment duration 6. Infants whose maternal diet has also remained unchanged during treatment
Exclusion criteria
Exclusion criteria: 1. Clinically significant co-existing illness or major medical problem, which, in the opinion of the treating physician, does not make the patient suitable for participation in the study 2. Diagnosis of any other gastrointestinal disorder 3. Failure to thrive, as determined by the treating physician 4. Use of antibiotics two weeks before enrolment and throughout the treatment period with Bifidobacterium lactis BB-12 or SOC as per the investigator s choice with no probiotic, for infantile colic, for both infant and mother 5. Use of probiotics two weeks before enrolment or during the treatment period with Bifidobacterium lactis BB-12 or SOC as per the investigator s choice with no probiotic, 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. Infants receiving solid foods, such as cereals, mashed fruits, vegetables
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in daily average crying time upon treatment with Bifidobacterium lactis BB-12 or SOC till week 1, week 2, week 3, and week 4 from baseline (i.e., Day 0 also referred to as Visit 1) 2. Proportion of infants achieving more than equal to 50 percentage reduction in daily average crying time till week 4 of treatment with Bifidobacterium lactis BB-12 or SOC 3.Treatment duration required for the treatment with Bifidobacterium lactis BB-12 or SOC to achieve more than equal to 50 percentage reduction in daily average crying time from baseline (i.e., Day 0 also referred to as Visit 1) 4. Reduction in crying episodes till week 1, week 2, week 3, and week 4 from baseline (i.e., Day 0 also referred to as Visit 1) upon treatment with Bifidobacterium lactis BB-12 or SOCTimepoint: Baseline, week 1, week 2, week 3 and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of infants with reported adverse events upon treatment with Bifidobacterium lactis BB-12 or SOCTimepoint: Baseline, week 1, week 2, week 3 and week 4;Exploratory Endpoint 1. Change in Fussiness on a Fussiness Rating Scale (FRS) from baseline at the end of week 1 and week 4 from baseline (i.e., Day 0 also referred to as Visit 1) between the treatment arms (with Bifidobacterium lactis BB-12 or SOC 2. Parental perception of colic severity on a 0 to 10 Visual Analogue Scale (VAS Scale) at the end of week 1 and week 4 from baseline (i.e., Day 0 also referred to as Visit 1) between Bifidobacterium lactis BB-12 and SOC 3. Physician s perception of colic severity (i.e., abdominal distension, including bloating, swollen or tight tummy) on a 0 to 10 Visual Analogue Scale (VAS Scale) at the end of week 1 and week 4 from baseline (i.e., Day 0 also referred to as Visit 1) between the treatment arms with Bifidobacterium lactis BB-12 or SOCTimepoint: Baseline, week 1, week 2, week 3 and week 4;Exploratory Endpoint 4. Change in abdominal distension, including bloating, swollen or tight tummy from baseline to the end of Week 1, Week 2, and Week 4 on a 0 to 10 rating scale compared between the treatment arms with Bifidobacterium lactis BB-12 or SOCTimepoint: Baseline, week 1, week 2, week 3 and week 4 | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt Ltd
Outcome results
None listed