Health BehaviorPhase 4NCT02406937

New Stage 1 Formula on Gut Comfort and Gut Health

A Phase 4 study testing Oral intake of Feihe New Formula, Oral intake of Feihe Stage 1 Formula and Breast Feeding in people with Health Behavior, run by Heilongjiang Feihe Dairy Co. Ltd. at 1 site in China.

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

180 qualified subjects aged from 7 days to 90 days will be enrolled with the 144 completed in study (allowing for a 20% drop-out rate). Subjects will be randomly assigned into 3 groups, including breast feeding, commercial and new formula group. Study intervention is 12 weeks. Read more about this study

Who is it for?: Ages 7 to 90 daysHealthy volunteers can take part
Conditions the study is for: Health Behavior
What is being tested?: Oral intake of Feihe New Formula, Oral intake of Feihe Stage 1 Formula and Breast Feeding
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteChina
Study dates: Jan 2015to Aug 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 90 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Infants aged 7-90 days;
Fed by breast milk before enrollment;
Parent or legal guardian fully understand the purpose and requirement, including the potential risks and side effects of the study;
Willing to participate in the study and comply all the procedures;
Concent form signed by parents.

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;
Think about the need to exclude C-section delivered infants? It's often the majority of births in Chinese tier-1 cities, so it will probably make the study recruitment slower, and postpone the study. The microflora of C-section infants in known to be different compared to normally born infants. At least, the mode of delivery should be noted and calculated into the primary and secondary outcome measurements as a potential confounding factor
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;

Show all 13Show fewer

Having taken any food containing prebiotics or probiotics tithing 15 days of enrollment;
Having gluten allergy (celiac disease);
Body weight-to-height Z-value<-3 according to the standard of WHO;
Receiving hormone therapy and intravenous nutrition;
Lactose intolerance or allergic to ingredients of study product;
Have participated in other clinical studies within 3 months prior to the date of screening;
Unable to comply the study schedule.

Trial locations and contacts

1 site in 1 country.

China1 site

Sprim (Shanghai) Consulting Co., Ltd.
Shanghai, Shanghai Municipality, 200336

Other trials in China

About this study

Official title: Efficacy of New Stage 1 Formula on the Improvement of Gut Comfort and Gut Health

Read the detailed description

Primary objective:

Improvement on gut health and infant comfort

Secondary objective：

Efficacy on easy digestion;
Changes on SCFA in feces(Baseline and Endpoint)
Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended)
Changes on sIgA in feces(Baseline and Endpoint)
Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time;
Incidence of eczema and duration;
Infants growth

Conditions: Health Behavior
Being tested: Oral intake of Feihe New Formula, Oral intake of Feihe Stage 1 Formula, Breast Feeding
Medical subject headings: Health Behavior

What participants receive

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

Oral intake of Feihe New FormulaDietary supplement
Oral intake of Feihe New Formula
Oral intake of Feihe Stage 1 FormulaDietary supplement
Oral intake of Feihe Stage 1 Formula
Breast FeedingDietary supplement
Oral intake of breast milk

Study groups in NCT02406937
Study group	Role	What they receive
Feihe New Formula	Experimental	Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients. Receives: Dietary Supplement: Oral intake of Feihe New Formula
Feihe Stage 1 Formula	Active comparator	Oral intake of Feihe stage 1 formula Receives: Dietary Supplement: Oral intake of Feihe Stage 1 Formula
Breast Feeding	Placebo comparator	Oral intake of breast milk Receives: Dietary Supplement: Breast Feeding

What is being measured

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

Stool Frequency
Average daily stool frequency during the measurement week
Measured: Baseline, Week 4, Week 8, Week 12

Secondary outcomes (16)

Number of Participants With Gastrointestinal Symptoms
Number of participants with symptom of bloating and abdominal pain
Measured: Weekly (Baseline to Day 84)
Stool Consistency
Average Bristol Score during the measurement week. The seven types of stool are:
1. = Separate hard lumps, like nuts (difficult to pass)
2. = Sausage-shaped but lumpy
3. = Like a sausage but with cracks in its surface
4. = Like a sausage or snake, smooth and soft
5. = Soft blobs with clear-cut edges (passed easily)
6. = Fluffy pieces with ragged edges; a mushy stool
7. = Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 tending towards diarrhoea.
Measured: Baseline, Week 4, Week 8, Week 12
Crying Time
Questionnaire recorded by parents. Average crying time per day during the measurement week.
Measured: Baseline, Week 4, Week 8, Week 12
Fecal Concentration of Short Chain Fatty Acid
fecal concentration of acetate, propionate and butyrate acid
Measured: Baseline, Day 21
Body Length
Body length
Measured: Baseline, Day 28, Day 56, Day 84
Number of Participants With Eczema
Measured: Throughout the study period (84 days)
Fecal Laboratory Detection for sIgA
Measured: Baseline, Day 84
Fecal Bacterium Concentration
bifidobacterium, lactobacillus, clostridium perfringens
Measured: Baseline, Day 21
Eczema Duration
Measured: Throughout the study period (84 days)
Body Weight
Measured: Baseline, Day 28, Day 56, Day 84
Head Circumference
Measured: Baseline, Day 28, Day 56, Day 84
Chest Circumference
Measured: Baseline, Day 28, Day 56, Day 84
Milk Regurgitation Frequency
Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.
Measured: Baseline, Week 4, Week 8, Week 12
Milk Feeding Quantity
Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.
Measured: Baseline, Week 4, Week 8, Week 12
Sleeping Time
Questionnaire recorded by parents. Average sleeping time per day during the measurement week.
Measured: Baseline, Week 4, Week 8, Week 12
Body Mass Index (BMI)
BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2 (kilogram per square meter).
Measured: Baseline, Week 4, Week 8, Week 12

Timeline

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

Jan 2015Aug 2015

First posted2 Apr 2015 (estimated)
Study startJan 2015
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Health BehaviorStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02406937
Sponsor's protocol ID: 14-SC-9-FH-001
Status last verified: Aug 2016
First submitted: 30 Mar 2015
Last updated: 10 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of New Stage 1 Formula on the Improvement of Gut Comfort and Gut Health
ClinicalTrials.gov ID: NCT02406937
Acronym / sponsor ID: 14-SC-9-FH-001
Conditions: Health Behavior
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 2 Apr 2015 (estimated)
Results: Posted 10 Oct 2016

Clinical summary

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

Detailed description

Primary objective:

Improvement on gut health and infant comfort

Secondary objective：

Efficacy on easy digestion;
Changes on SCFA in feces(Baseline and Endpoint)
Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended)
Changes on sIgA in feces(Baseline and Endpoint)
Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time;
Incidence of eczema and duration;
Infants growth

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Feihe New Formula	Experimental	Dietary Supplement: Oral intake of Feihe New FormulaOral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.
Feihe Stage 1 Formula	Active comparator	Dietary Supplement: Oral intake of Feihe Stage 1 FormulaOral intake of Feihe stage 1 formula
Breast Feeding	Placebo comparator	Dietary Supplement: Breast FeedingOral intake of breast milk

Who may qualify

Ages: 7 to 90 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Infants aged 7-90 days;
Fed by breast milk before enrollment;
Parent or legal guardian fully understand the purpose and requirement, including the potential risks and side effects of the study;
Willing to participate in the study and comply all the procedures;
Concent form signed by parents.

Key exclusion criteria (13 listed)

Twins, multiple birth, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
Think about the need to exclude C-section delivered infants? It's often the majority of births in Chinese tier-1 cities, so it will probably make the study recruitment slower, and postpone the study. The microflora of C-section infants in known to be different compared to normally born infants. At least, the mode of delivery should be noted and calculated into the primary and secondary outcome measurements as a potential confounding factor
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;

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 intake of Feihe New FormulaOral intake of Feihe New Formula	Dietary supplement	Feihe New Formula
Oral intake of Feihe Stage 1 FormulaOral intake of Feihe Stage 1 Formula	Dietary supplement	Feihe Stage 1 Formula
Breast FeedingOral intake of breast milk	Dietary supplement	Breast Feeding

Primary outcome

Stool Frequency
Time frame: Baseline, Week 4, Week 8, Week 12
Average daily stool frequency during the measurement week

16 secondary outcomes

Number of Participants With Gastrointestinal Symptoms
Time frame: Weekly (Baseline to Day 84)
Stool Consistency
Time frame: Baseline, Week 4, Week 8, Week 12
Crying Time
Time frame: Baseline, Week 4, Week 8, Week 12
Fecal Concentration of Short Chain Fatty Acid
Time frame: Baseline, Day 21
Body Length
Time frame: Baseline, Day 28, Day 56, Day 84
Number of Participants With Eczema
Time frame: Throughout the study period (84 days)
Fecal Laboratory Detection for sIgA
Time frame: Baseline, Day 84
Fecal Bacterium Concentration
Time frame: Baseline, Day 21
Eczema Duration
Time frame: Throughout the study period (84 days)
Body Weight
Time frame: Baseline, Day 28, Day 56, Day 84
Head Circumference
Time frame: Baseline, Day 28, Day 56, Day 84
Chest Circumference
Time frame: Baseline, Day 28, Day 56, Day 84
Milk Regurgitation Frequency
Time frame: Baseline, Week 4, Week 8, Week 12
Milk Feeding Quantity
Time frame: Baseline, Week 4, Week 8, Week 12
Sleeping Time
Time frame: Baseline, Week 4, Week 8, Week 12
Body Mass Index (BMI)
Time frame: Baseline, Week 4, Week 8, Week 12

Results and safety

Results posted to the registry on 10 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Feihe New Formula	60	59
Feihe Formula	60	59
Breast Feeding	60	58

Primary outcome: Stool Frequency

Time frame: Baseline, Week 4, Week 8, Week 12. Mean (Standard Deviation). Unit: Times per day

Measure	Feihe New Formula n = 59	Feihe Formula n = 59	Breast Feeding n = 58
Baseline	2.2 (1.0)	2.2 (0.9)	2.3 (1.0)
Week 4	1.6 (0.5)	1.8 (0.6)	2.1 (0.7)
Week 8	1.2 (0.3)	1.6 (0.5)	1.5 (0.5)
Week 12	1.0 (0.3)	1.5 (0.4)	1.6 (0.4)

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Feihe New Formula	0 of 60 (0%)	0 of 60 (0%)	Not reported
Feihe Formula	0 of 60 (0%)	0 of 60 (0%)	Not reported
Breast Feeding	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jiancun Pan study director

Heilongjiang Feihe Dairy Co. Ltd.

1 site in 1 country: see every site and its status.

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 5 inclusion and 13 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 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 4, Week 8, Week 12). 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 NCT02406937.

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 10 Oct 2016.