Effect of Probiotics on the Digestibility and Immunity in Infants

NCT ID: NCT02317406

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-06-30

Brief Summary

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

Conditions

Gastrointestinal Tract Flora Composition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Biostime probiotics sachet children's formula

Intervention Type: DRUG

Biostime probiotics sachet children's formula,1.5g Oral Single dose

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

Group Type: PLACEBO_COMPARATOR

Biostime probiotics sachet children's formula（placebo）

Intervention Type: DRUG

Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose

Interventions

Biostime probiotics sachet children's formula

Biostime probiotics sachet children's formula,1.5g Oral Single dose

Intervention Type: DRUG

Biostime probiotics sachet children's formula（placebo）

Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose

Intervention Type: DRUG

Eligibility Criteria

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.)

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biostime Institute of Nutrition and Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

PEC13036

Identifier Type: -

Identifier Source: org_study_id