{
  "FullStudy":{
    "Rank":217879,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515644",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CT.01.2010"
          },
          "Organization":{
            "OrgFullName":"PT. Sari Husada",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Study on the Effect of Inulin in Infant Formula on Gut Health",
          "OfficialTitle":"A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants",
          "Acronym":"STAR-IFFO"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 5, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 22, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 24, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"PT. Sari Husada",
            "LeadSponsorClass":"INDUSTRY"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Danone Research",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool.\n\nIt is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy Infants"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Healthy infants",
              "Infant formula",
              "Prebiotics"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"164",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Intervention group I",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Intervention group I: Powder based Infant formula with Inulin I",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Powder based infant formula"
                  ]
                }
              },{
                "ArmGroupLabel":"Intervention group II",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Intervention group II: Powder based Infant formula with Inulin II",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Powder based infant formula"
                  ]
                }
              },{
                "ArmGroupLabel":"Intervention group III",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Intervention group III: Powder based Infant formula without Inulin",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Powder based infant formula"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Powder based infant formula",
                "InterventionDescription":"Powder based infant formula with Inulin I",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Intervention group I"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Powder based infant formula",
                "InterventionDescription":"Powder based infant formula with Inulin II",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Intervention group II"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Powder based infant formula",
                "InterventionDescription":"Powder based infant formula without Inulin",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Intervention group III"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Difference between beneficial bacteria I level in stool at week 4 and week 8.",
                "PrimaryOutcomeTimeFrame":"Week 4, Week 8."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Difference between beneficial bacteria II level in stool at week 4 and week 8.",
                "SecondaryOutcomeTimeFrame":"Week 4, Week 8."
              },{
                "SecondaryOutcomeMeasure":"Difference between pH of stool at week 4 and week 8.",
                "SecondaryOutcomeTimeFrame":"Week 4, Week 8."
              },{
                "SecondaryOutcomeMeasure":"Difference between stool consistency at week 4 and week 8.",
                "SecondaryOutcomeTimeFrame":"Week 4, Week 8."
              },{
                "SecondaryOutcomeMeasure":"Difference between sIgA at week 4 and week 8.",
                "SecondaryOutcomeTimeFrame":"Week 4, Week 8."
              },{
                "SecondaryOutcomeMeasure":"Difference between SCFA at week 4 and week 8.",
                "SecondaryOutcomeTimeFrame":"Week 4, Week 8."
              },{
                "SecondaryOutcomeMeasure":"Safety and tolerability.",
                "SecondaryOutcomeDescription":"The safety and tolerability achieved by continuous recording of adverse events, including the occurrence of diarrhea and constipation.",
                "SecondaryOutcomeTimeFrame":"From date of baseline visit (day 1) until the date of visit 8 (day 56)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria at screening:\n\nHealthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard\nFully formula-fed in the 28 days prior to inclusion\nExpected investigational product intake of min 500ml per day\nWritten informed consent from the parents\n\nExclusion criteria at screening:\n\nLow birth weight (LBW) less than 2,000g.\nDisorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required)\nUse of systemic antibiotics or antimycotics medication in the 14 days prior to the study\nSignificant congenital abnormality that will interfere with the study objectives in the opinion of the investigator.\nInvestigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.\nParticipation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.\n\nExclusion criteria for intervention period:\n\nNot consuming study product longer than 2 days consecutively\nIntake of study product is less than 500ml per day for 7 days",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"3 Months",
          "MaximumAge":"4 Months",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Hanifah Oswari, dr., Sp.A(K), PhD",
                "OverallOfficialAffiliation":"Research Unit of Indonesian Pediatrics Association",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Research Unit of Indonesian Pediatrics Association",
                "LocationCity":"Jakarta",
                "LocationCountry":"Indonesia"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}