Comparative A1 vs A2 Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant

Intestinal Absorption Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081936
• Other study ID #: 15-SC-6-A2-003
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2016
• Last updated: March 10, 2017
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: a2 Milk Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Days to 60 Days

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Absorption

Intervention

Dietary Supplement:
• Oral consumption of Nutricia Aptamil Stage 1 formula
Daily oral consumption of Nutricia Aptamil Stage 1 formula
• Oral consumption of a2® Platinum Stage 1 formula
Daily oral consumption of a2® Platinum Stage 1 formula
• Oral consumption of breast milk
Daily oral consumption of breast milk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
a2 Milk Company Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool frequency	Change from Baseline weekly average of the number of defecation per day at 8 weeks	Baseline, Week 8
Secondary	Stool consistency	Weekly average score of stool consistency	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary	Stool color	Weekly average score of stool color	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary	Fecal Myeloperoxidase (MPO) concentration		Baseline, Day 7, Day 56
Secondary	Fecal Short Chain Fatty Acid (SCFA) concentration	Acetic Acid , Propanoic Acid, Butanoic Acid, Total SCFA	Baseline, Day 7, Day 56
Secondary	Fecal sIgA concentration		Baseline, Day 7, Day 56
Secondary	Fecal microflora counts	Bifidobacterium, Lactobacillus, Clostridium perfringens	Baseline, Day 7, Day 56
Secondary	Body weight	Body weight (unit: g)	Baseline, Day 7, Day 56
Secondary	Body height	Body height (unit: cm)	Baseline, Day 7, Day 56
Secondary	Head circumstance	Head circumstance (unit: cm)	Baseline, Day 7, Day 56
Secondary	Chest circumstance	Chest circumstance (unit: cm)	Baseline, Day 7, Day 56
Secondary	Cry frequency	Weekly average of cry frequency per day	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary	Cry duration	Weekly average of cumulative cry duration per day	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary	Sleep duration	Weekly average of cumulative sleep duration per day	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary	Milk regurgitation frequency	Weekly average of milk regurgitation frequency per day	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8