New Stage 1 Formula on Gut Comfort and Gut Health

NCT ID: NCT02406937

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

Brief 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.

Detailed Description

Primary objective:

1. Improvement on gut health and infant comfort

Secondary objective：

1. Efficacy on easy digestion;

2. Changes on SCFA in feces(Baseline and Endpoint)

3. Improvement on gut microbiome strains(Baseline and Day 21); (bifidobacterium/lactobacillus/clostridium perfringens recommended)

4. Changes on sIgA in feces(Baseline and Endpoint)

5. Improvement on tolerance(comfort) via infant fussy/bloating/abdominal pain/milk regurgitation/sleeping time;

6. Incidence of eczema and duration;

7. Infants growth

Conditions

Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Feihe New Formula

Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.

Group Type: EXPERIMENTAL

Oral intake of Feihe New Formula

Intervention Type: DIETARY_SUPPLEMENT

Oral intake of Feihe New Formula

Feihe Stage 1 Formula

Oral intake of Feihe stage 1 formula

Group Type: ACTIVE_COMPARATOR

Oral intake of Feihe Stage 1 Formula

Intervention Type: DIETARY_SUPPLEMENT

Oral intake of Feihe Stage 1 Formula

Breast Feeding

Oral intake of breast milk

Group Type: PLACEBO_COMPARATOR

Breast Feeding

Intervention Type: DIETARY_SUPPLEMENT

Oral intake of breast milk

Interventions

Oral intake of Feihe New Formula

Oral intake of Feihe New Formula

Intervention Type: DIETARY_SUPPLEMENT

Oral intake of Feihe Stage 1 Formula

Oral intake of Feihe Stage 1 Formula

Intervention Type: DIETARY_SUPPLEMENT

Breast Feeding

Oral intake of breast milk

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heilongjiang Feihe Dairy Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiancun Pan

Role: STUDY_DIRECTOR

Heilongjiang Feihe Dairy Co. Ltd.

Locations

Sprim (Shanghai) Consulting Co., Ltd.

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

14-SC-9-FH-001

Identifier Type: -

Identifier Source: org_study_id