Recruiting All Strictly Breast-fed Babies With Blood In Stool

NCT ID: NCT02745977

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-04-24

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.

Conditions

Breast Milk Protein Intolerance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dairy Free Diet- guaiac + on dairy free diet

Dairy Free Diet x 3 weeks then stool guaiac positive

Group Type: OTHER

Dairy Free Diet

Intervention Type: OTHER

Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.

Guaiac negative on dairy free diet

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

Group Type: OTHER

Dairy Free Diet

Intervention Type: OTHER

Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.

Interventions

Dairy Free Diet

Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Winthrop University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Farrah Lazare, MD

Attending Physician, Pediatric Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Winthrop Pediatric Associates

Mineola, New York, United States

Countries

United States

Other Identifiers

14021

Identifier Type: -

Identifier Source: org_study_id