Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT02317406
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.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
6 Months
Study:
NCT02317406
Study Brief:
Protocol Section:
NCT02317406