Effect of Probiotics on the Digestibility and Immunity in Infants

Biostime Institute of Nutrition and Care

Status: Completed

Conditions: Gastrointestinal Tract Flora Composition

Treatments: Drug: Biostime probiotics sachet children's formula（placebo）; Drug: Biostime probiotics sachet children's formula

Study type: Interventional

Funder types: Other

Identifiers

NCT02317406

PEC13036

Details and patient eligibility

About

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

Enrollment: 133 patients

Sex: All

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

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

Treatment:

Drug: Biostime probiotics sachet children's formula

Probiotics simulation

Placebo Comparator group

Description:

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

Treatment:

Drug: Biostime probiotics sachet children's formula（placebo）