Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-01 @ 11:35 PM
Study NCT ID:
NCT05480059
Status:
UNKNOWN
Last Update Posted:
2022-07-29
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome', 'timeFrame': 'baseline', 'description': 'A Questionnaire-based Assessment of the Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBS - Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '29072609', 'type': 'BACKGROUND', 'citation': 'Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. J Clin Med. 2017 Oct 26;6(11):99. doi: 10.3390/jcm6110099.'}, {'pmid': '26838486', 'type': 'BACKGROUND', 'citation': 'Kibune Nagasako C, Garcia Montes C, Silva Lorena SL, Mesquita MA. Irritable bowel syndrome subtypes: Clinical and psychological features, body mass index and comorbidities. Rev Esp Enferm Dig. 2016 Feb;108(2):59-64. doi: 10.17235/reed.2015.3979/2015.'}, {'pmid': '20535320', 'type': 'BACKGROUND', 'citation': 'Lee OY. Prevalence and risk factors of irritable bowel syndrome in Asia. J Neurogastroenterol Motil. 2010 Jan;16(1):5-7. doi: 10.5056/jnm.2010.16.1.5. Epub 2010 Jan 31. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the relation between the clinical presentations and the psychiatric co-morbidities with the quality of life in patients with irritable bowel syndrome.', 'detailedDescription': 'IBS is a chronic functional disorder characterized by abdominal pain and altered bowel habit in the absence of a specific and unique organic pathology.\n\nRome IV criteria is used to diagnose IBS patients which depends on the presence of recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with 2 or more of the following; related to defecation, associated with change in frequency of stool , associated with change in stool form. These criteria should be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.\\]1.\\[ brian et al 2017)\\[ IBS sub-types include 4 sub-types described according to the dominant stool pattern diarrhea (IBS -D) , constipation (IBS- C) , mixed ( IBS-M) , unspecified( IBS-U) subtypes . \\] \\[2 Cristiane Kibune Nagasako et al 2016 \\[ The Identified Risk factors for IBS include female sex , younger age , psychological stress during or before infectious gastroenteritis , and the severity of enteritis. \\[3 \\] Oh Young Lee et al 2010\n\nIBS is a painful condition associated with significant psychological distress and psychiatric comorbidities such as higher levels of anxiety or depression and suicidal ideation, with a negative impact on quality of life \\[4 \\] .Canavan et al., 2014; Stasiet al., 2014).\n\nMajor psychiatric disorders seen in patients were GAD and MDE. GAD was seen in 30.0% of patients having IBS while MDE was present in 28.0% \\[5\\]\n\nTherefore, IBS consequences are measured in direct costs; medical treatment and procedures or indirect costs such as reduced productivit and low quality of life.\\[6\\] Doshi et al., 2014a However, few studies were conducted to evaluate the impact of clinical presentations or psychiatric co-morbidities with the quality of life in IBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient age between 18 - 50 years old, fulfilling Rome IV criteria with normal investigations', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- Patient age between 18 - 50 years old 2- Patients fulfilling Rome IV criteria with normal investigations such as CBC, ESR , liver and kidney function and \\\\ or colonoscopy 3- Healthy control: who do not fulfil Rome IV criteria with normal investigations\n\nExclusion Criteria:\n\n* 1- Those older than 50 years of age with recent onset of symptoms (less than 6 months).\n\n 2- Organic causes of colonic symptom. 3- Patients with IBS who have alarm signs. 4- Those with coexisting diseases (e.g. intestinal parasites, malignancy, diabetes mellitus cardiovascular pulmonary, hepatic, or renal disorder).\n\n 5- Those with a family history of colorectal cancer. 6- IBS in children (\\< 18 years) and IBD-IBS patients'}, 'identificationModule': {'nctId': 'NCT05480059', 'briefTitle': 'Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'Irritable bowel syndrome'}}, 'armsInterventionsModule': {'interventions': [{'name': 'A questionnaire', 'type': 'OTHER', 'description': 'A Questionnaire-based Assessment of the Psychiatric Co-morbidities and Health-related Quality of life in Patients with Irritable Bowel Syndrome'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Elhussiny', 'role': 'CONTACT', 'email': 'ahmedelhosieny298@gmail.com', 'phone': '01157104164'}, {'name': 'Ahlam Farghaly', 'role': 'CONTACT', 'email': 'Ahlamgastro2000@yahoo.com', 'phone': '01221729540'}], 'overallOfficials': [{'name': 'Heidi Ramadan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ahmed Elhussiny', 'investigatorFullName': 'Ahmed Elhussiny Salah Mahmoud', 'investigatorAffiliation': 'Assiut University'}}}}