An interventional study of Dairy Free Diet in Breast Milk Protein Intolerance, sponsored by Winthrop University Hospital. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by Winthrop University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Winthrop University Hospital is the lead sponsor of 42 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Dairy Free Diet x 3 weeks then stool guaiac positive
Other: Dairy Free Diet
on dairy free diet x 3 weeks, then stool guaiac negative
Other: Dairy Free Diet
Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.
Presence of blood in the stool as evidenced by positive stool guaiac
If guaiac positive, then dairy is reintroduced to diet
Time frame: 3 weeks
guaiac negative on diary free diet
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
Time frame: 3 weeks
Plan to share: No
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Winthrop University Hospital