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Completed

NCT Number: NCT03081936

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

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.

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Key information

Age range

40 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral consumption of Nutricia Aptamil Stage 1 formula

Dietary Supplement

Daily oral consumption of Nutricia Aptamil Stage 1 formula

Oral consumption of a2® Platinum Stage 1 formula

Dietary Supplement

Daily oral consumption of a2® Platinum Stage 1 formula

Oral consumption of breast milk

Dietary Supplement

Daily oral consumption of breast milk

Primary outcomes

  1. Stool frequency

    Time frame: Baseline, Week 8

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

Secondary outcomes

  1. Stool consistency

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

    Weekly average score of stool consistency

  2. Stool color

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

    Weekly average score of stool color

  3. Fecal Myeloperoxidase (MPO) concentration

    Time frame: Baseline, Day 7, Day 56

  4. Fecal Short Chain Fatty Acid (SCFA) concentration

    Time frame: Baseline, Day 7, Day 56

    Acetic Acid , Propanoic Acid, Butanoic Acid, Total SCFA

  5. Fecal sIgA concentration

    Time frame: Baseline, Day 7, Day 56

  6. Fecal microflora counts

    Time frame: Baseline, Day 7, Day 56

    Bifidobacterium, Lactobacillus, Clostridium perfringens

  7. Body weight

    Time frame: Baseline, Day 7, Day 56

    Body weight (unit: g)

  8. Body height

    Time frame: Baseline, Day 7, Day 56

    Body height (unit: cm)

  9. Head circumstance

    Time frame: Baseline, Day 7, Day 56

    Head circumstance (unit: cm)

  10. Chest circumstance

    Time frame: Baseline, Day 7, Day 56

    Chest circumstance (unit: cm)

  11. Cry frequency

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

    Weekly average of cry frequency per day

  12. Cry duration

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

    Weekly average of cumulative cry duration per day

  13. Sleep duration

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

    Weekly average of cumulative sleep duration per day

  14. Milk regurgitation frequency

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

    Weekly average of milk regurgitation frequency per day

Sponsors and collaborators

Lead sponsor

a2 Milk Company Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2017
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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