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

NCT03081936 | Completed Phase 4

• 1 other identifier: 15-SC-6-A2-003
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intestinal Absorption

Outcome Measures

Primary Outcomes (1)

• Stool frequency

  Change from Baseline weekly average of the number of defecation per day at 8 weeks

  Baseline, Week 8

Secondary Outcomes (14)

• Stool consistency

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

• Stool color

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

• Fecal Myeloperoxidase (MPO) concentration

  Baseline, Day 7, Day 56

• Fecal Short Chain Fatty Acid (SCFA) concentration

  Baseline, Day 7, Day 56

• Fecal sIgA concentration

  Baseline, Day 7, Day 56

Study Arms (3)

A1 formula

ACTIVE COMPARATOR

Oral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk)

Dietary Supplement: Oral consumption of Nutricia Aptamil Stage 1 formula

A2 formula

EXPERIMENTAL

Oral consumption of a2® Platinum Stage 1 formula (containing 100% A2® beta -casein)

Dietary Supplement: Oral consumption of a2® Platinum Stage 1 formula

Breast feeding

ACTIVE COMPARATOR

Oral consumption of breast milk

Dietary Supplement: Oral consumption of breast milk

Interventions

Oral consumption of Nutricia Aptamil Stage 1 formula DIETARY_SUPPLEMENT

Daily oral consumption of Nutricia Aptamil Stage 1 formula

A1 formula

Oral consumption of a2® Platinum Stage 1 formula DIETARY_SUPPLEMENT

Daily oral consumption of a2® Platinum Stage 1 formula

A2 formula

Oral consumption of breast milk DIETARY_SUPPLEMENT

Daily oral consumption of breast milk

Breast feeding

Eligibility Criteria

• Age: 40 Days - 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Charlie Zhang, MD

  Sprim (Shanghai) Consulting Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: March 17, 2017
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share