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OpenTrials
Completed

NCT Number: NCT02745977

Recruiting All Strictly Breast-fed Babies With Blood In Stool

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Winthrop Pediatric Associates

Mineola, New York, 11501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dairy Free Diet

Other

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Registry information

Official study title

Breast Milk Protein Intolerance and Maternal Dairy Consumption

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2016
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.