Health Condition 1: K638- Other specified diseases of intestine
Conditions
Interventions
Intervention1: Combination of Probiotic, Digestive enzymes Carminatives
(Tummy soft drops): Each 5 ml contains
Bacillus coagulans 500 million
GBI-30, 6086
Alpha Amylase (1:800) 25mg
Pepsin (1:
Sponsors
Jhaver Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants (age 3 months to 1 year) fulfilling the Rome-IV diagnostic criteria for infantile colic with no evidence of acute/ chronic illness. 2. Rome-IV diagnostic for clinical research purposes, diagnosis of infantile colic also includes both of the following. 3. Caregiver reports infant has cried or fussed for three or more hours per day during three or more days in 7 days in a telephone or face-to-face screening interview; and 4. Total 24-h crying plus fussing in the selected group of infants is confirmed to be three h or more when measured by at least one prospectively kept 24-h behaviour diary. 5. Parents who report their infant crying excessively must be screened on an outpatient basis.
Exclusion criteria
Exclusion criteria: 1. Infants born before completing 34 weeks of gestation or birth weight 2. Infants with known gastrointestinal disorders, previous abdominal surgery, known galactosemia or diabetes mellitus will be excluded from the study. 3. Infants with severe dehydration. 4. Presence of systemic infections. 6. Infants with known immunocompromising morbidities. 7. Infants with severe acute malnutrition. 8. Infants with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination. 9. Infants with cystic fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After a 5-day study, the primary outcome will be assessed by the clinical response which is defined as the percentage of infants achieving a reduction in the daily average crying time 50%Timepoint: 5-days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. After a 5-day study, the secondary outcome will be assessed by the occurrence of adverse events (Milk regurgitation, vomiting, diarrhoea, constipation) following the administration of digestive enzymes, carminatives & probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow. Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the dairyTimepoint: after 5 days | — |
Countries
India
Contacts
Public ContactDr. G. Raj Kamal
Chengalpattu medical college
Outcome results
None listed