Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-04 @ 2:28 PM
Study NCT ID:
NCT05523427
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-14', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.', 'timeFrame': 'Three months', 'description': 'The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBS', 'IBS-D', 'Abdominal pain', 'Abdominal distention', 'Probiotic', 'Lactobacilli', 'Mucus', 'L. plantarum', 'L. acidophilus'], 'conditions': ['Irritable Bowel Syndrome', 'Irritable Bowel Syndrome With Diarrhea']}, 'descriptionModule': {'briefSummary': 'Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS', 'detailedDescription': 'Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease\'s diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 16-55\n2. Both genders\n3. Patients diagnosed clinically with IBS based on Rome's criteria\n4. IBS-Diarrhea only with pain \\& distention\n5. Duration of symptoms 6 months\n\nExclusion Criteria:\n\n1. Age \\> 55\n2. Celiac disease\n3. Inflammatory bowel disease (ulcerative colitis \\& Crohn's)\n4. Thyroid disease\n5. Colonic CA\n6. Lactose intolerance\n7. Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)\n8. Preexisting use of antibiotics in the previous 3 months.\n9. Preexisting systemic diseases"}, 'identificationModule': {'nctId': 'NCT05523427', 'briefTitle': 'Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Mosul'}, 'officialTitle': 'Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CCMRE-phA-22-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard treatment of IBS', 'description': 'Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg\n\nThey were administered in a single capsule, three time daily before meals.'}, {'type': 'EXPERIMENTAL', 'label': 'Probiotics + Standard treatment of IBS', 'description': 'A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.', 'interventionNames': ['Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)']}], 'interventions': [{'name': 'Two probiotic strains (L. plantarum and L. acidophilus)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.', 'armGroupLabels': ['Probiotics + Standard treatment of IBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41001', 'city': 'Mosul', 'state': 'Ninevah', 'country': 'Iraq', 'facility': 'University of Mosul', 'geoPoint': {'lat': 36.335, 'lon': 43.11889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mosul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Radhwan Al-Zidan', 'investigatorAffiliation': 'University of Mosul'}}}}