NCT02406937

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Heilongjiang Feihe Dairy Co. Ltd. · Industry
• Sex: All
• Age: 7 Days – 90 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral intake of Feihe New Formula	Oral intake of Feihe New Formula
DIETARY_SUPPLEMENT	Oral intake of Feihe Stage 1 Formula	Oral intake of Feihe Stage 1 Formula
DIETARY_SUPPLEMENT	Breast Feeding	Oral intake of breast milk

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-04-02
• Last updated: 2016-10-10
• Results posted: 2016-10-10

Locations

1 site across 1 country: China