Recruiting All Strictly Breast-fed Babies With Blood In Stool

May 8, 2017 updated by: Farrah Lazare, MD, Winthrop University Hospital

Breast Milk Protein Intolerance and Maternal Dairy Consumption

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop Pediatric Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winthrop University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

April 24, 2017

Study Completion (ACTUAL)

April 24, 2017

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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