Recruiting All Strictly Breast-fed Babies With Blood In Stool

NYU Langone Hospitals

Status: Completed

Conditions: Breast Milk Protein Intolerance

Treatments: Other: Dairy Free Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02745977

14021

Details and patient eligibility

About

Breast feeding is the most nutritious form of nourishment in infants and is recommended for at least the first four months of life. Breast fed infants may develop milk protein intolerance. The management of breast milk protein intolerance differs from that of cow's milk protein intolerance in formula fed infants. Because breast milk is considered by many to be nutritionally superior to formula and results in maternal infant bonding mothers are often told to continue breast feeding. Despite the lack of evidence based data to support or refute the modification of the mother's diet, it is suggested that they eliminate their own intake of dairy products strictly and avoid supplementing with a cow's milk based formula. Investigators are doing this study to demonstrate that the deletion of dairy from the diet of a breast feeding mother will not cause breast milk protein intolerance to resolve.

Full description

Breast feeding is the most nutritious form of nourishment in infants and is recommended for at least the first four months of life. Breast fed infants may develop milk protein intolerance. The management of breast milk protein intolerance differs from that of cow's milk protein intolerance in formula fed infants. Because breast milk is considered by many to be nutritionally superior to formula and results in maternal infant bonding mothers are often told to continue breast feeding. Despite the lack of evidence based data to support or refute the modification of the mother's diet, it is suggested that they eliminate their own intake of dairy products strictly and avoid supplementing with a cow's milk based formula. The investigators are doing this study to demonstrate that the deletion of dairy from the diet of a breast feeding mother will not cause breast milk protein intolerance to resolve.Some infants have difficulty digesting breast milk. When this happens, the doctor may advise the mother to eliminate dairy from her diet as long as the mother continues breast feeding or until the baby is 12 months old. However, no studies have proven that this change in a mother's diet actually solves the baby's problem with breast milk. The purpose of this study is to find an answer to this question.

Enrollment: 25 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with exclusively breast fed infants less than 4 months of age
• Infant that has a positive stool guaiac

Exclusion criteria

• Formula fed infants

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Dairy Free Diet- guaiac + on dairy free diet

Other group

Description:

Dairy Free Diet x 3 weeks then stool guaiac positive

Treatment:

Other: Dairy Free Diet

Guaiac negative on dairy free diet

Other group

Description:

on dairy free diet x 3 weeks, then stool guaiac negative

Treatment:

Other: Dairy Free Diet