Clinical trial NCT02317406: Effect of Probiotics on the Digestibility and Immunity in Infants
Official title: Effect of Probiotics on the Digestibility and Immunity in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tract Flora Composition
Lead sponsor: Biostime Institute of Nutrition and Care
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 133
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.)

Primary outcomes:
measure: Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention.
timeFrame: From Baseline to week 4
measure: Change of Lactobacillus helveticuspopulations in stool
timeFrame: From Baseline to week 4
Secondary outcomes:
measure: average daily number of stools
timeFrame: From Baseline to week 4
measure: Aaverage daily Infant Stool Form scores consistency
timeFrame: From Baseline to week 4
measure: Average weekly Infant Stool Form scores amount
timeFrame: From Baseline to week 4
measure: Average weekly Infant Stool Form scores color
timeFrame: From Baseline to week 4
measure: Average daily number of crying episodes
timeFrame: From Baseline to week 4
measure: Average daily duration of crying episodes
timeFrame: From Baseline to week 4
measure: sIgA antibody levels in stool
timeFrame: From Baseline to week 4
measure: sIgA antibody levels in saliva
timeFrame: From Baseline to week 4
measure: change in infant weight
timeFrame: From Baseline to week 4
measure: change in infant length
timeFrame: From Baseline to week 4
measure: change in infant head circumference
timeFrame: From Baseline to week 4
measure: The number of AE and SAE
timeFrame: From Baseline to week 4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
References: