Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-01 @ 12:24 AM
Study NCT ID:
NCT06856434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients with Diffuse Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'White Blood Cells Level', 'timeFrame': 'From the day of randomization up to 5 days postoperatively', 'description': "A white blood count measures the number of white blood cells (WBCs) in patients' blood."}], 'secondaryOutcomes': [{'measure': 'Segmented Neutrophil level', 'timeFrame': 'From the day of randomization up to 5 days postoperatively', 'description': 'Segmented neutrophils are the most mature neutrophilic granulocytes present in circulating blood'}, {'measure': 'Post operative pain level', 'timeFrame': 'From the day of randomization up to 5 days postoperatively', 'description': "The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'"}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'From the day of randomization up to 5 days postoperatively', 'description': 'The duration of a single episode of hospitalization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perforated Appendicitis', 'Appendectomy', 'Probiotic', 'Laparotomy'], 'conditions': ['Appendicitis with Perforation', 'Appendectomy', 'Probiotic']}, 'referencesModule': {'references': [{'pmid': '36814190', 'type': 'BACKGROUND', 'citation': 'Guan L, Liu Z, Pan G, Zhang B, Wu Y, Gan T, Ouyang G. The global, regional, and national burden of appendicitis in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. BMC Gastroenterol. 2023 Feb 22;23(1):44. doi: 10.1186/s12876-023-02678-7.'}]}, 'descriptionModule': {'briefSummary': 'Does the administration of the probiotic Lactobacillus plantarum sp. have an impact on reducing leukocyte levels, segmented neutrophil counts, postoperative pain, and length of hospitalization in patients with diffuse peritonitis caused by perforated acute appendicitis who underwent laparotomy appendectomy at Dr. Hasan Sadikin Hospital?', 'detailedDescription': 'To determine whether the administration of the probiotic Lactobacillus plantarum sp. to patients with diffuse peritonitis caused by appendiceal perforation undergoing laparotomy appendectomy at Hasan Sadikin Hospital Bandung and Siloam Karawaci Hospital has a significant effect on leukocyte levels, segmented neutrophil counts, postoperative pain levels, and length of hospitalization compared to the placebo group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with diffuse peritonitis caused by appendicitis\n* Patients undergoing laparotomic appendectomy.\n* Patients aged 18 years or older.\n\nExclusion Criteria:\n\n* Patients with a history of previous laparotomy.\n* Patients who underwent laparotomy combined with surgery on other parts of the body.\n* Patients with a history of cancer.\n* Patients with pre-existing comorbidities (uncontrolled diabetes mellitus, congestive heart failure, end-stage renal disease \\[ESRD\\], human immunodeficiency virus \\[HIV\\], and systemic lupus erythematosus \\[SLE\\]).\n* Patients with multiple organ dysfunction syndrome (MODS).\n* Patients with prior consumption of probiotics.'}, 'identificationModule': {'nctId': 'NCT06856434', 'briefTitle': "Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients with Diffuse Peritonitis", 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'Effect of Consumption of Lactobacillus Plantarum Sp Probiotics on Leukocyte Levels, Segment Neutrophil Type Counts, Post-operative Pain, and Length of Stay in Patients with Diffuse Peritonitis Due to the Perforated Appendix That Has Been Performed Laparotomy Appendectomy At Dr. Hasan Sadikin Hospital: a Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'SURG-202407.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic Group', 'description': 'Patient with perforated appendicitis who received an intervention', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum sp Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Patients with perforated appendicitis who did not receive an intervention', 'interventionNames': ['Other: Placebo Group']}], 'interventions': [{'name': 'Lactobacillus plantarum sp Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once daily consumption', 'armGroupLabels': ['Probiotic Group']}, {'name': 'Placebo Group', 'type': 'OTHER', 'description': 'Group who received a placebo intervention', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ricarhdo Valentino Hanafi, MD', 'role': 'CONTACT', 'email': 'ricarhdo22001@mail.unpad.ac.id', 'phone': '+628111951997'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'All data will be available for public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ricarhdo Valentino Hanafi, MD', 'investigatorAffiliation': 'Universitas Padjadjaran'}}}}