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New Stage 1 Formula on Gut Comfort and Gut Health

Health Behavior Clinical Trial

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

Clinical 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02406937
Study type Interventional
Source Heilongjiang Feihe Dairy Co. Ltd.
Contact
Status Completed
Phase Phase 4
Start date January 2015
Completion date August 2015
View Details
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