Clinical trial NCT02406937: New Stage 1 Formula on Gut Comfort and Gut Health
Official title: Efficacy of New Stage 1 Formula on the Improvement of Gut Comfort and Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Health Behavior
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Stool Frequency
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Number of Participants With Gastrointestinal Symptoms
timeFrame: Weekly (Baseline to Day 84)
measure: Stool Consistency
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Crying Time
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Fecal Concentration of Short Chain Fatty Acid
timeFrame: Baseline, Day 21
measure: Body Length
timeFrame: Baseline, Day 28, Day 56, Day 84
measure: Number of Participants With Eczema
timeFrame: Throughout the study period (84 days)
measure: Fecal Laboratory Detection for sIgA
timeFrame: Baseline, Day 84
measure: Fecal Bacterium Concentration
timeFrame: Baseline, Day 21
measure: Eczema Duration
timeFrame: Throughout the study period (84 days)
measure: Body Weight
timeFrame: Baseline, Day 28, Day 56, Day 84
measure: Head Circumference
timeFrame: Baseline, Day 28, Day 56, Day 84
measure: Chest Circumference
timeFrame: Baseline, Day 28, Day 56, Day 84
measure: Milk Regurgitation Frequency
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Milk Feeding Quantity
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Sleeping Time
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Body Mass Index (BMI)
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sprim (Shanghai) Consulting Co., Ltd.
state: Shanghai
Study officials:
affiliation: Heilongjiang Feihe Dairy Co. Ltd.
name: Jiancun Pan
role: STUDY_DIRECTOR
References: