Recruiting All Strictly Breast-fed Babies With Blood In Stool
- Conditions
- Breast Milk Protein Intolerance
- Interventions
- Other: Dairy Free Diet
- Registration Number
- NCT02745977
- Lead Sponsor
- Winthrop University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- Women with exclusively breast fed infants less than 4 months of age
- Infant that has a positive stool guaiac
- Formula fed infants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dairy Free Diet- guaiac + on dairy free diet Dairy Free Diet Dairy Free Diet x 3 weeks then stool guaiac positive Guaiac negative on dairy free diet Dairy Free Diet on dairy free diet x 3 weeks, then stool guaiac negative
- Primary Outcome Measures
Name Time Method Presence of blood in the stool as evidenced by positive stool guaiac 3 weeks If guaiac positive, then dairy is reintroduced to diet
guaiac negative on diary free diet 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Winthrop Pediatric Associates
🇺🇸Mineola, New York, United States