Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Probiotic Lactobacillus reuteri UBL Ru-87: 5 drops of Lactobacillus reuteri UBL Ru-87 contains 100 million colony-forming units
Control Intervention1: Placebo: 5 drops contains Sun flow
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: from birth to 2. Diagnosed with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment) according to Rome III criteria 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 5. Birth weight = 2500g 6. Apgar score more than 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 enrollment and throughout the intervention period, for both infant and mother 5. Use of probiotics two weeks before enrollment 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 |
|---|---|
| •Treatment success, defined as the percentage of children achieving a reduction in the daily average crying time to less than 3 hrs., and the duration of crying (minutes per day) at 7,14, 21 and 28 days after randomization with reference to baseline (recorded daily by parent as well)Timepoint: Visit 1 Screening and baseline assessment. Treatment Initiation (day 0) Visit 2 Follow-up 1 (Day 07 ± 2 days) Visit 3 Follow-up 2 (Day 14 ± 2 days) Visit 4 Follow-up 3 (Day 21 ± 2 days) Visit 5 End of study (Day 28 ± 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| a. The percentage of children achieving a reduction in the daily average crying time defined as the percentage of children achieving a reduction in the daily average crying time =50% (Timeline on day 28 with reference to baseline) b. Persistence of infantile colic after the intervention (Timeline on day 28 with reference to baseline) c. Parental perceptions of colic severity; & parental/ family quality of life. To assess infantile colic (parental) a 10-cm visual analog scale (VAS) will be used. The possible scores ranged from0 to 10. For the parent’s perception of colic severity, 0 indicates no pain & 10 indicated the worst pain. For the parental/family quality of life, 0 indicates no effect & 10 indicates a very good effect. Parents will be instructed how to use the VAS scale prior to the study (Timeline baseline/Day 0, Day 7, Day 14, Day 21 & Day 28). d. Analysis of gut microbiota from fecal samples at baseline & EOTTimepoint: Visit 1 Screening & baseline assessment. Treatment Initiation (day 0) Visit 2 Follow-up 1 (Day 07 ± 2 days) Visit 3 Follow-up 2 (Day 14 ± 2 days) Visit 4 Follow-up 3 (Day 21 ± 2 days) Visit 5 End of study (Day 28 ± 2 days) | — |
Countries
India
Contacts
Public ContactDr Jayanthi
Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri Hospital and Research Centre
Outcome results
None listed