New Stage 1 Formula on Gut Comfort and Gut Health

NCT02406937 | Completed Phase 4 Results

• 1 other identifier: 14-SC-9-FH-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (1)

• Stool Frequency

  Average daily stool frequency during the measurement week

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (16)

• Number of Participants With Gastrointestinal Symptoms

  Weekly (Baseline to Day 84)

• Stool Consistency

  Baseline, Week 4, Week 8, Week 12

• Crying Time

  Baseline, Week 4, Week 8, Week 12

• Fecal Concentration of Short Chain Fatty Acid

  Baseline, Day 21

• Body Length

  Baseline, Day 28, Day 56, Day 84

Study Arms (3)

Feihe New Formula

EXPERIMENTAL

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

Dietary Supplement: Oral intake of Feihe New Formula

Feihe Stage 1 Formula

ACTIVE COMPARATOR

Oral intake of Feihe stage 1 formula

Dietary Supplement: Oral intake of Feihe Stage 1 Formula

Breast Feeding

PLACEBO COMPARATOR

Oral intake of breast milk

Dietary Supplement: Breast Feeding

Interventions

Oral intake of Feihe New Formula DIETARY_SUPPLEMENT

Oral intake of Feihe New Formula

Feihe New Formula

Oral intake of Feihe Stage 1 Formula DIETARY_SUPPLEMENT

Oral intake of Feihe Stage 1 Formula

Feihe Stage 1 Formula

Breast Feeding DIETARY_SUPPLEMENT

Oral intake of breast milk

Breast Feeding

Eligibility Criteria

• Age: 7 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.: lead

Study Sites (1)

Sprim (Shanghai) Consulting Co., Ltd.

Shanghai, Shanghai Municipality, 200336, China

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Lactation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Results Point of Contact

• Title: Dr. Charlie Zhang
• Organization: Sprim (Shanghai) Consulting Co., Ltd.

charlie.zhang@sprim.cn

+86 (21) 51097272

Study Officials

• Jiancun Pan

  Heilongjiang Feihe Dairy Co. Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 10, 2016
• Results First Posted: October 10, 2016

Record last verified: 2016-08

Locations

CN (1)