Effect of Probiotics on the Digestibility and Immunity in Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02317406
• Date of registration: 08/12/2014
• Prospective Registration: No
• Primary sponsor: Biostime Institute of Nutrition and Care
• Public title: Effect of Probiotics on the Digestibility and Immunity in Infants
• Scientific title: Effect of Probiotics on the Digestibility and Immunity in Infants
• Date of first enrolment: December 2014
• Target sample size: 133
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02317406
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

China

Key inclusion & exclusion 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.)



Age minimum: 4 Months
Age maximum: 6 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Gastrointestinal Tract Flora Composition

Intervention(s)

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

Drug: Biostime probiotics sachet children's formula

Primary Outcome(s)

Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention. [Time Frame: From Baseline to week 4]

Change of Lactobacillus helveticuspopulations in stool [Time Frame: From Baseline to week 4]

Secondary Outcome(s)

Average daily number of crying episodes [Time Frame: From Baseline to week 4]

sIgA antibody levels in saliva [Time Frame: From Baseline to week 4]

average daily number of stools [Time Frame: From Baseline to week 4]

change in infant head circumference [Time Frame: From Baseline to week 4]

sIgA antibody levels in stool [Time Frame: From Baseline to week 4]

Aaverage daily Infant Stool Form scores consistency [Time Frame: From Baseline to week 4]

change in infant weight [Time Frame: From Baseline to week 4]

The number of AE and SAE [Time Frame: From Baseline to week 4]

change in infant length [Time Frame: From Baseline to week 4]

Average daily duration of crying episodes [Time Frame: From Baseline to week 4]

Average weekly Infant Stool Form scores amount [Time Frame: From Baseline to week 4]

Average weekly Infant Stool Form scores color [Time Frame: From Baseline to week 4]

Secondary ID(s)

PEC13036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors