Recruiting All Strictly Breast-fed Babies With Blood In Stool

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breast Milk Protein Intolerance and Maternal Dairy Consumption

Conditions
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Breast Milk Protein Intolerance

Intervention / Treatment
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* Other: Dairy Free Diet


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dairy Free Diet- guaiac + on dairy free diet<br>Dairy Free Diet x 3 weeks then stool guaiac positive | Other: Dairy Free Diet<br>* Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.<br>|
| Other: Guaiac negative on dairy free diet<br>on dairy free diet x 3 weeks, then stool guaiac negative | Other: Dairy Free Diet<br>* Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of blood in the stool as evidenced by positive stool guaiac | If guaiac positive, then dairy is reintroduced to diet | 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 | 3 weeks |