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Clinical Trials/NCT02745977
NCT02745977CompletedNot Applicable

Breast Milk Protein Intolerance and Maternal Dairy Consumption

Winthrop University Hospital1 site in 1 country25 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Presence of blood in the stool as evidenced by positive stool guaiac

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Dairy Free Diet- guaiac + on dairy free diet

Other

Dairy Free Diet x 3 weeks then stool guaiac positive

Intervention: Dairy Free Diet (Other)

Guaiac negative on dairy free diet

Other

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

Intervention: Dairy Free Diet (Other)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Farrah Lazare, MD

Attending Physician, Pediatric Gastroenterology

Winthrop University Hospital

Study Sites (1)

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