Effect of Probiotics on the Digestibility and Immunity in Infants
Not Applicable
Completed
- Conditions
- Gastrointestinal Tract Flora Composition
- Interventions
- Drug: Biostime probiotics sachet children's formula（placebo）Drug: Biostime probiotics sachet children's formula
- Registration Number
- NCT02317406
- Lead Sponsor
- Biostime Institute of Nutrition and Care
- Brief Summary
The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
Inclusion Criteria
- Healthy infants;
- Single birth;
- Gestational age ≥ 37 weeks (=non-preterm infant, WHO);
- Birth weight: > 2500g
- Appropriate weight between P20-P80 in accordance with the weight percentile standards of the children ages 0 to 6 years in Shanghai urban areas at inclusion visit ;
- Aged > 4 months and < 6 months;
- Infants being exclusively formula-fed(no breast milk meal) at inclusion visit;
- No suffering of gastrointestinal diseases within 1 month (CCDC recommendations);
- Parents agreeing to use one of the recommended infant formulas (no probiotic, if with prebiotics, exclude it when there is GOS over 2g/100g or FOS inside);
- Consent form signed by at least one of the parents or by the legal tutor properly informed of the study;
- Parents able to understand the protocol requirements and to fill out the infants' diary.
Exclusion Criteria
- Congenital illness or malformation;
- Significant pre-natal and/or post-natal disease;
- Mothers with metabolic or chronic diseases;
- Infants with allergic constitution and sensitive to the probiotics (CCDC recommendations);
- Infants with serious diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases and internal secretion diseases, and those with mental disorder (CCDC recommendations);
- Infants administering other drugs during the administering of the study products, thus impossible to judge the efficacy or influencing the judgment of results (CCDC recommendations);
- Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgment;
- Infant under oral antibiotic treatment at V1 visit and within the 4 weeks before V1
- Infants who used any medication or nutritional supplements (including probiotics, prebiotics etc, except for infant formula) in the 4 weeks preceding study start;
- Infants who have ever consumed the test product;
- Infants who have medical conditions for which a special diet other than standard (non hydrolyzed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia);
- Currently participating or having participated in another clinical trial during the last month.
- Infants whose legal representatives have psychological or linguistic incapability to sign the informed consent form
- Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotics simulation Biostime probiotics sachet children's formula（placebo） Biostime probiotics sachet children's formula（placebo）, 1.5g/d/sachet, administrated during the consumption of the first feeding-bottle of the day. Duration: 4 weeks Probiotics Biostime probiotics sachet children's formula Biostime probiotics sachet children's formula, 1.5g/d/sachet, administrated during the consumption of the first feeding-bottle of the day. Duration: 4 weeks
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention. From Baseline to week 4 GI tract flora include Bifidobacterium, Lactobacillus, Clostridium perfringens, Enterococcus, Enterobacter, Bacteroides. Modulatory effect of GI tract flora composition was defined as two definitions. The first definition is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change and Enterococcus, Enterobacter, Bacteroides has no obvious change. The other is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change, Enterobacter and/or Enterococcus, Bacteroides increases significantly, but the amplification less than Lactobacillus/Bifidobacterium.
Change of Lactobacillus helveticuspopulations in stool From Baseline to week 4
- Secondary Outcome Measures
Name Time Method average daily number of stools From Baseline to week 4 Aaverage daily Infant Stool Form scores consistency From Baseline to week 4 Average weekly Infant Stool Form scores amount From Baseline to week 4 Average weekly Infant Stool Form scores color From Baseline to week 4 Average daily number of crying episodes From Baseline to week 4 Average daily duration of crying episodes From Baseline to week 4 sIgA antibody levels in stool From Baseline to week 4 sIgA antibody levels in saliva From Baseline to week 4 change in infant weight From Baseline to week 4 change in infant length From Baseline to week 4 change in infant head circumference From Baseline to week 4 The number of AE and SAE From Baseline to week 4
Trial Locations
- Locations (1)
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, Shanghai, China