Clinical trial NCT03081936: Comparative A1 vs A2 Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intestinal Absorption
Lead sponsor: a2 Milk Company Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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;
* Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
* Currently taking medicines for cardiovascular or metabolic disease ;
* Currently suffering from any gastrointestinal disorders or gastrointestinal disease , including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
* Had hospitalizations within 3 months before screening;
* According to investigator's judgment, current frequent users of drugs which may affect the gastrointestinal function or immune system;
* Unable to comply the study schedule.

Primary outcomes:
measure: Stool frequency
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Stool consistency
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Stool color
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Fecal Myeloperoxidase (MPO) concentration
timeFrame: Baseline, Day 7, Day 56
measure: Fecal Short Chain Fatty Acid (SCFA) concentration
timeFrame: Baseline, Day 7, Day 56
measure: Fecal sIgA concentration
timeFrame: Baseline, Day 7, Day 56
measure: Fecal microflora counts
timeFrame: Baseline, Day 7, Day 56
measure: Body weight
timeFrame: Baseline, Day 7, Day 56
measure: Body height
timeFrame: Baseline, Day 7, Day 56
measure: Head circumstance
timeFrame: Baseline, Day 7, Day 56
measure: Chest circumstance
timeFrame: Baseline, Day 7, Day 56
measure: Cry frequency
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Cry duration
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Sleep duration
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Milk regurgitation frequency
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Other outcomes:
Locations:
Study officials:
affiliation: Sprim (Shanghai) Consulting Co., Ltd.
name: Charlie Zhang, MD
role: STUDY_DIRECTOR
References: