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Recruiting All Strictly Breast-fed Babies With Blood In Stool

Breast Milk Protein Intolerance and Maternal Dairy Consumption

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02745977
Enrollment
25
Registered
2016-04-20
Start date
2014-06-30
Completion date
2017-04-24
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Protein Intolerance

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.

Interventions

OTHERDairy Free Diet

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

Sponsors

Winthrop University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of blood in the stool as evidenced by positive stool guaiac3 weeksIf guaiac positive, then dairy is reintroduced to diet
guaiac negative on diary free diet3 weeksif 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026