Comparative Effects of A1 Versus A2®Cow Milk Based Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant: a Pilot Double-blinded, Randomized, Controlled Parallel Study

a2 Milk Company Ltd.0 sites33 target enrollmentNovember 2015

ConditionsIntestinal Absorption

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Intestinal Absorption
Sponsor: a2 Milk Company Ltd.
Enrollment: 33
Primary Endpoint: Stool frequency
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk based formula on alimentation and gastrointestinal digestion. The impact of the study products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and infant growth were also evaluated.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

a2 Milk Company Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing to formula feeding and consume 600ml or more of IF each day;
•Have normal electrocardiograms (ECG) and blood pressure during quiet respiration.
•Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
•Parent(s) or legal guardian's consent to the study and willing to comply with study procedures;
•Parent(s) or guardian of infant agrees not to enroll infant another clinical study while participating in this study;
•Fully understand the nature, objective, benefit and the potential risks and side effects of the study.

Exclusion Criteria

•Twins, multiple birth, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
•During pregnancy, the mothers had pregnancy complications or other disease that may affect the results;
•Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other disease;
•Having neonatal diarrhea or acute respiratory infections within 48hours before enrollment;
•Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
•Having taken any food containing prebiotics or probiotics tithing 15 days of enrollment;
•Body weight-to-height Z-value \<-3 according to the standard of the World Health Organization (WHO);
•Receiving hormone therapy and intravenous nutrition;
•Lactose intolerance or allergic to ingredients of study product;
•Have history of faecal impaction;