Effect of Probiotics on the Digestibility and Immunity in Infants

The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tract Flora Composition
• Intervention / Treatment: Drug: Biostime probiotics sachet children's formula; Drug: Biostime probiotics sachet children's formula（placebo）

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai first maternity and infant hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; 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	Drug: Biostime probiotics sachet children's formula; Biostime probiotics sachet children's formula,1.5g Oral Single dose
Placebo Comparator: Probiotics simulation; 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	Drug: Biostime probiotics sachet children's formula（placebo）; Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention.	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.	From Baseline to week 4
Change of Lactobacillus helveticuspopulations in stool		From Baseline to week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biostime Institute of Nutrition and Care

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PEC13036