Bleeding per rectum in an otherwise healthy infant is a common problem encountered by Pediatric
Gastroenterologists. Though benign and treatable most of the time; management often involves using
expensive formulas. It is estimated that 2-3% of infants suffer from Cow’s milk protein intolerance
(CMPI), with about 50% of this reaction being non-IgE mediated. Allergic protocolitis is a common
manifestation of non-IgE mediated CMPI. The most common presentation of this disorder is an otherwise
healthy infant with streaks of blood with or without mucus and /or diarrhea. It is reported that more than
half of such children are exclusively breast fed. It is assumed that milk and/or soy protein from maternal
diet find their way in the breast milk causing an allergic reaction.The commonly accepted treatment
strategy is eliminating intact cow’s milk protein from the diet of the infant. In formula-fed infants, protein
hydrolysate , elemental or soy formulas are used . In breast-fed babies, dietary modifications such as
eliminating milk and soy from maternal diet or switching the infant to a semi elemental or elemental diet
have been suggested. There appears to be a lack of objective clinical data on presentation, course,
response to therapy and long term prognosis of this disorder.
Aim:
To evaluate the role of change of formula or maternal dietary changes (in exclusively breast fed infants)
in the prognosis of children with CMPI. This will be achieved by documenting, comparing and
contrasting different management styles of individual practitioners participating in the study.
Method:
Multicenter collaborative non-interventional observational study
Hypothesis:
1. Change to elemental or semi-elemental formula is not helpful in resolving rectal bleeding in children
with allergic proctitis due to CMPI.
2. In exclusively breast fed infants, change of maternal diet is not helpful in resolving rectal bleeding in
children with allergic proctitis due to CMPI.