To evaluate the efficacy of digestive enzymes, carminatives & probiotics in the management of infantile colic in a tertiary care hospital in South India - NI

Jhaver Research Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•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.

•1. Infants born before completing 34 weeks of gestation or birth weight < 2500 g and inadequate weight gain ( < 125 g/wk.).
•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.

发起方

Jhaver Research Foundation