Nctid:
NCT06231056
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000011248", "term"=>"Pregnancy Complications"}], "ancestors"=>[{"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "asFound"=>"Complicating Pregnancy", "relevance"=>"HIGH"}, {"id"=>"M25869", "name"=>"Premature Birth", "relevance"=>"LOW"}, {"id"=>"M9547", "name"=>"Hemolysis", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T367", "name"=>"Bifidobacterium", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"Control group"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Probiotic supplement group"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>250}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-06-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-20", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2020-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Bacteriological assessment", "timeFrame"=>"12 weeks", "description"=>"Control of bacteriuria by urine culture (number of participants)"}, {"measure"=>"Bacteriological assessment", "timeFrame"=>"12 weeks", "description"=>"Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab"}, {"measure"=>"Clinical assessments at the end of pregnancy", "timeFrame"=>"12 weeks", "description"=>"Incidence of Prelabor rupture of membranes (PROM)"}, {"measure"=>"Clinical assessments at the end of pregnancy", "timeFrame"=>"12 weeks", "description"=>"Incidence of Preterm PROM (PPROM)"}, {"measure"=>"Clinical assessments at the end of pregnancy", "timeFrame"=>"12 weeks", "description"=>"Incidence of Preterm birth"}, {"measure"=>"clinical assessments at the end of pregnancy", "timeFrame"=>"12 weeks", "description"=>"Rate of natural or caesarean section mode"}, {"measure"=>"Clinical assessments at the end of pregnancy", "timeFrame"=>"12 weeks", "description"=>"Incidence of induction of child birth"}], "secondaryOutcomes"=>[{"measure"=>"Rate of incidence of side effects", "timeFrame"=>"12 weeks", "description"=>"Number of participants presenting any side effects"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Genitourinary; Infection, Complicating Pregnancy"]}, "descriptionModule"=>{"briefSummary"=>"Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.", "detailedDescription"=>"There is strong scientific evidence that supports the correlation between bacterial vaginosis (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth. Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and the onset of BV. The latter, however, are not without risks, as they can in turn cause alterations in the vaginal microbiota and is associated with an increased risk of miscarriage.\n\nRecent research have shown that probiotic treatment can help reduc the risk of preterm birth and positivity of Group B β-hemolytic streptococcus (GBS) infection.\n\nThe present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as prophylaxis of GBS infections and urine culture positivity.\n\nThis was a retrospective, observational, controlled and single centre study."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"45 years", "minimumAge"=>"18 years", "genderBased"=>true, "genderDescription"=>"The study is only applicable in pregnant female.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Pregnant women in 24-36 weeks of gestation period\n* History of recurrent genitourinary and/or intestinal problems\n\nExclusion Criteria:\n\n* Presence of neurological condition\n* History of cardiovascular disease\n* History of pulmonary disease\n* History of renal disease\n* Cancer"}, "identificationModule"=>{"nctId"=>"NCT06231056", "briefTitle"=>"Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection", "organization"=>{"class"=>"OTHER", "fullName"=>"Liaquat University of Medical & Health Sciences"}, "officialTitle"=>"Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth", "orgStudyIdInfo"=>{"id"=>"LUMHS/iNatal/20.01.2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Probiotic supplement group", "description"=>"Participants in this group received probiotic iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) - dosage 1 sachet per day, during the 24-36 weeks of their gestation period.", "interventionNames"=>["Dietary Supplement: Probiotic iNatal®"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control group", "description"=>"No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period."}], "interventions"=>[{"name"=>"Probiotic iNatal®", "type"=>"DIETARY_SUPPLEMENT", "description"=>"iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)", "armGroupLabels"=>["Probiotic supplement group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"06122", "city"=>"Perugia", "country"=>"Italy", "facility"=>"Department of Obstetrics and Gynecology PERUGIA HOSPITAL", "geoPoint"=>{"lat"=>43.1122, "lon"=>12.38878}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Liaquat University of Medical & Health Sciences", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Università degli Studi dell'Insubria", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Clinical Biochemistry and Experimental Medicine", "investigatorFullName"=>"Dr. Amjad Khan", "investigatorAffiliation"=>"Liaquat University of Medical & Health Sciences"}}}}
