New Stage 1 Formula on Gut Comfort and Gut Health

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Dietary supplement: Oral intake of Feihe New Formula; Dietary supplement: Oral intake of Feihe Stage 1 Formula; Dietary supplement: Breast Feeding

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

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200336
      • Sprim (Shanghai) Consulting Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feihe New Formula; Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.	Dietary supplement: Oral intake of Feihe New Formula; Oral intake of Feihe New Formula
Active Comparator: Feihe Stage 1 Formula; Oral intake of Feihe stage 1 formula	Dietary supplement: Oral intake of Feihe Stage 1 Formula; Oral intake of Feihe Stage 1 Formula
Placebo Comparator: Breast Feeding; Oral intake of breast milk	Dietary supplement: Breast Feeding; Oral intake of breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Frequency	Average daily stool frequency during the measurement week	Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Gastrointestinal Symptoms	Number of participants with symptom of bloating and abdominal pain	Weekly (Baseline to Day 84)
Stool Consistency	Average Bristol Score during the measurement week. The seven types of stool are: = Separate hard lumps, like nuts (difficult to pass); = Sausage-shaped but lumpy; = Like a sausage but with cracks in its surface; = Like a sausage or snake, smooth and soft; = Soft blobs with clear-cut edges (passed easily); = Fluffy pieces with ragged edges; a mushy stool; = 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.	Baseline, Week 4, Week 8, Week 12
Crying Time	Questionnaire recorded by parents. Average crying time per day during the measurement week.	Baseline, Week 4, Week 8, Week 12
Fecal Concentration of Short Chain Fatty Acid	fecal concentration of acetate, propionate and butyrate acid	Baseline, Day 21
Body Length	Body length	Baseline, Day 28, Day 56, Day 84
Number of Participants With Eczema		Throughout the study period (84 days)
Fecal Laboratory Detection for sIgA		Baseline, Day 84
Fecal Bacterium Concentration	bifidobacterium, lactobacillus, clostridium perfringens	Baseline, Day 21
Eczema Duration		Throughout the study period (84 days)
Body Weight		Baseline, Day 28, Day 56, Day 84
Head Circumference		Baseline, Day 28, Day 56, Day 84
Chest Circumference		Baseline, Day 28, Day 56, Day 84
Milk Regurgitation Frequency	Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.	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.	Baseline, Week 4, Week 8, Week 12
Sleeping Time	Questionnaire recorded by parents. Average sleeping time per day during the measurement week.	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).	Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
• Investigators: Study Director: Jiancun Pan, Heilongjiang Feihe Dairy Co. Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14-SC-9-FH-001