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 Details — Status: Completed

Administrative data

• NCT number: NCT02406937
• Other study ID #: 14-SC-9-FH-001
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2015
• Last updated: October 19, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Heilongjiang Feihe Dairy Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 90 Days

Eligibility

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 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

• Health Behavior

Intervention

Dietary Supplement:
• Oral intake
Oral intake

Locations

Country	Name	City	State
China	Sprim (Shanghai) Consulting Co., Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang Feihe Dairy Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms	bloating, abdominal pain	Weekly (Baseline to Day 84)	No
Secondary	Stool frequency		Weekly (Baseline to Day 84)	No
Secondary	Stool consistency	Measured by Bristol Score	Weekly (Baseline to Day 84)	No
Secondary	Subject comfort	Questionnaire recorded by parents: fussy frequency and duration, milk regurgitation frequency, product/breast feeding quantity, feeding of complementary food and sleeping time, crying time.	Weekly (Baseline to Day 84)	No
Secondary	Fecal concentration of Short Chain Fatty Acid	acetate, propionate, butyrate	Baseline, Day 21	No
Secondary	Anthropometric measurements (composite)	Body length, body weight, BMI, head circumference and chest circumference.	Baseline, Day 28, Day 56, Day 84	Yes
Secondary	Eczema incidence and duration		Weekly (Baseline to Day 84)	No
Secondary	Fecal laboratory detection for sIgA		Baseline, Day 84	No
Secondary	Fecal bacterium concentration	bifidobacterium, lactobacillus, clostridium perfringens	Baseline, Day 21	No