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Clinical Trials/NCT02745977
NCT02745977
Completed
Not Applicable

Breast Milk Protein Intolerance and Maternal Dairy Consumption

Winthrop University Hospital1 site in 1 country25 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Milk Protein Intolerance
Sponsor
Winthrop University Hospital
Enrollment
25
Locations
1
Primary Endpoint
Presence of blood in the stool as evidenced by positive stool guaiac
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
April 24, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Farrah Lazare, MD

Attending Physician, Pediatric Gastroenterology

Winthrop University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Presence of blood in the stool as evidenced by positive stool guaiac

Time Frame: 3 weeks

If guaiac positive, then dairy is reintroduced to diet

guaiac negative on diary free diet

Time Frame: 3 weeks

if guaiac negative on dairy free diet after 3 weeks, will rechallenge with dairy to prove that blood in stool is caused by dairy in mother's diet

Study Sites (1)

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