Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-01 @ 11:59 AM
Study NCT ID:
NCT02317406
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on the Digestibility and Immunity in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention.', 'timeFrame': 'From Baseline to week 4', 'description': 'GI tract flora include Bifidobacterium, Lactobacillus, Clostridium perfringens, Enterococcus, Enterobacter, Bacteroides. Modulatory effect of GI tract flora composition was defined as two definitions. The first definition is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change and Enterococcus, Enterobacter, Bacteroides has no obvious change. The other is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change, Enterobacter and/or Enterococcus, Bacteroides increases significantly, but the amplification less than Lactobacillus/Bifidobacterium.'}, {'measure': 'Change of Lactobacillus helveticuspopulations in stool', 'timeFrame': 'From Baseline to week 4'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Tract Flora Composition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy infants;\n* Single birth;\n* Gestational age ≥ 37 weeks (=non-preterm infant, WHO);\n* Birth weight: \\> 2500g\n* 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 ;\n* Aged \\> 4 months and \\< 6 months;\n* Infants being exclusively formula-fed(no breast milk meal) at inclusion visit;\n* No suffering of gastrointestinal diseases within 1 month (CCDC recommendations);\n* 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);\n* Consent form signed by at least one of the parents or by the legal tutor properly informed of the study;\n* Parents able to understand the protocol requirements and to fill out the infants' diary.\n\nExclusion Criteria:\n\n* Congenital illness or malformation;\n* Significant pre-natal and/or post-natal disease;\n* Mothers with metabolic or chronic diseases;\n* Infants with allergic constitution and sensitive to the probiotics (CCDC recommendations);\n* 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);\n* 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);\n* 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;\n* Infant under oral antibiotic treatment at V1 visit and within the 4 weeks before V1\n* Infants who used any medication or nutritional supplements (including probiotics, prebiotics etc, except for infant formula) in the 4 weeks preceding study start;\n* Infants who have ever consumed the test product;\n* 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);\n* Currently participating or having participated in another clinical trial during the last month.\n* Infants whose legal representatives have psychological or linguistic incapability to sign the informed consent form\n* 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.)"}, 'identificationModule': {'nctId': 'NCT02317406', 'briefTitle': 'Effect of Probiotics on the Digestibility and Immunity in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Biostime Institute of Nutrition and Care'}, 'officialTitle': 'Effect of Probiotics on the Digestibility and Immunity in Infants', 'orgStudyIdInfo': {'id': 'PEC13036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', '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", 'interventionNames': ["Drug: Biostime probiotics sachet children's formula"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Probiotics simulation', '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", 'interventionNames': ["Drug: Biostime probiotics sachet children's formula（placebo）"]}], 'interventions': [{'name': "Biostime probiotics sachet children's formula", 'type': 'DRUG', 'description': "Biostime probiotics sachet children's formula,1.5g Oral Single dose", 'armGroupLabels': ['Probiotics']}, {'name': "Biostime probiotics sachet children's formula（placebo）", 'type': 'DRUG', 'description': "Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose", 'armGroupLabels': ['Probiotics simulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai First Maternity and Infant Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biostime Institute of Nutrition and Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}