Intestinal AbsorptionPhase 4NCT03081936

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

A Phase 4 study testing Oral consumption of Nutricia Aptamil Stage 1 formula, Oral consumption of a2® Platinum Stage 1 formula and Oral consumption of breast milk in people with Intestinal Absorption, run by a2 Milk Company Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 40 to 60 daysHealthy volunteers can take part
Conditions the study is for: Intestinal Absorption
What is being tested?: Oral consumption of Nutricia Aptamil Stage 1 formula, Oral consumption of a2® Platinum Stage 1 formula and Oral consumption of breast milk
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: No sites listed yet
Study dates: Nov 2015to Feb 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 60 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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;

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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.

About this study

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

Conditions: Intestinal Absorption
Being tested: Oral consumption of Nutricia Aptamil Stage 1 formula, Oral consumption of a2® Platinum Stage 1 formula, Oral consumption of breast milk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral consumption of Nutricia Aptamil Stage 1 formulaDietary supplement
Daily oral consumption of Nutricia Aptamil Stage 1 formula
Oral consumption of a2® Platinum Stage 1 formulaDietary supplement
Daily oral consumption of a2® Platinum Stage 1 formula
Oral consumption of breast milkDietary supplement
Daily oral consumption of breast milk

Study groups in NCT03081936
Study group	Role	What they receive
A1 formula	Active comparator	Oral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk) Receives: 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) Receives: Dietary Supplement: Oral consumption of a2® Platinum Stage 1 formula
Breast feeding	Active comparator	Oral consumption of breast milk Receives: Dietary Supplement: Oral consumption of breast milk

What is being measured

The primary outcome is the main question the study is designed to answer.

Stool frequency
Change from Baseline weekly average of the number of defecation per day at 8 weeks
Measured: Baseline, Week 8

Secondary outcomes (14)

Stool consistency
Weekly average score of stool consistency
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Stool color
Weekly average score of stool color
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Fecal Myeloperoxidase (MPO) concentration
Measured: Baseline, Day 7, Day 56
Fecal Short Chain Fatty Acid (SCFA) concentration
Acetic Acid , Propanoic Acid, Butanoic Acid, Total SCFA
Measured: Baseline, Day 7, Day 56
Fecal sIgA concentration
Measured: Baseline, Day 7, Day 56
Fecal microflora counts
Bifidobacterium, Lactobacillus, Clostridium perfringens
Measured: Baseline, Day 7, Day 56
Body weight
Body weight (unit: g)
Measured: Baseline, Day 7, Day 56
Body height
Body height (unit: cm)
Measured: Baseline, Day 7, Day 56
Head circumstance
Head circumstance (unit: cm)
Measured: Baseline, Day 7, Day 56
Chest circumstance
Chest circumstance (unit: cm)
Measured: Baseline, Day 7, Day 56
Cry frequency
Weekly average of cry frequency per day
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Cry duration
Weekly average of cumulative cry duration per day
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Sleep duration
Weekly average of cumulative sleep duration per day
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Milk regurgitation frequency
Weekly average of milk regurgitation frequency per day
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Feb 2016

First posted17 Mar 2017
Study startNov 2015
Primary completionJan 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intestinal AbsorptionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03081936
Sponsor's protocol ID: 15-SC-6-A2-003
Status last verified: Mar 2017
First submitted: 1 Nov 2016
Last updated: 17 Mar 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Gut Oxalate Absorption in Calcium Oxalate Stone Disease
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All Intestinal Absorption trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03081936
Acronym / sponsor ID: 15-SC-6-A2-003
Conditions: Intestinal Absorption
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: a2 Milk Company Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jan 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 17 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
A1 formula	Active comparator	Dietary Supplement: Oral consumption of Nutricia Aptamil Stage 1 formulaOral consumption of Nutricia Aptamil Stage 1 formula (traditional cow milk)
A2 formula	Experimental	Dietary Supplement: Oral consumption of a2® Platinum Stage 1 formulaOral consumption of a2® Platinum Stage 1 formula (containing 100% A2® beta -casein)
Breast feeding	Active comparator	Dietary Supplement: Oral consumption of breast milkOral consumption of breast milk

Who may qualify

Ages: 40 to 60 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral consumption of Nutricia Aptamil Stage 1 formulaDaily oral consumption of Nutricia Aptamil Stage 1 formula	Dietary supplement	A1 formula
Oral consumption of a2® Platinum Stage 1 formulaDaily oral consumption of a2® Platinum Stage 1 formula	Dietary supplement	A2 formula
Oral consumption of breast milkDaily oral consumption of breast milk	Dietary supplement	Breast feeding

Primary outcome

Stool frequency
Time frame: Baseline, Week 8
Change from Baseline weekly average of the number of defecation per day at 8 weeks

14 secondary outcomes

Stool consistency
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Stool color
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Fecal Myeloperoxidase (MPO) concentration
Time frame: Baseline, Day 7, Day 56
Fecal Short Chain Fatty Acid (SCFA) concentration
Time frame: Baseline, Day 7, Day 56
Fecal sIgA concentration
Time frame: Baseline, Day 7, Day 56
Fecal microflora counts
Time frame: Baseline, Day 7, Day 56
Body weight
Time frame: Baseline, Day 7, Day 56
Body height
Time frame: Baseline, Day 7, Day 56
Head circumstance
Time frame: Baseline, Day 7, Day 56
Chest circumstance
Time frame: Baseline, Day 7, Day 56
Cry frequency
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Cry duration
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Sleep duration
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Milk regurgitation frequency
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
Individual participant dataSharing planned: No

Related trials for Intestinal Absorption

Recruiting
Digestion and Absorption of Postbiotic Regulatory Proteins
Protein Utilization
Active, not recruitingObservational study
Study on the Impact of Different Feeding Methods on Allergy Prevention and Digestive Absorption in Infants and Young Children
Infant Allergy, Infant Gut Health
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Recruiting
Gut Oxalate Absorption in Calcium Oxalate Stone Disease
Kidney Stone, Kidney Calculi
Recruiting
Does Paracetamol Influence the Release of Gut Hormones, Glucose Absorption and Glycemia?
Healthy Young Adults, Physiology

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charlie Zhang, MD study director

Sprim (Shanghai) Consulting Co., Ltd.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stool frequency (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03081936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.