Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-24 @ 11:48 PM
Study NCT ID:
NCT06770959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Gastrointestinal and Hepatic Manifestations Among Patients with Multiple Sclerosis, a Clinical Hospital Based Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Prevalence of git and hepatic manifestation in people with MS and its relations to MS treatment', 'timeFrame': '24 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MS (Multiple Sclerosis)']}, 'referencesModule': {'references': [{'pmid': '24163768', 'type': 'BACKGROUND', 'citation': "Levinthal DJ, Rahman A, Nusrat S, O'Leary M, Heyman R, Bielefeldt K. Adding to the burden: gastrointestinal symptoms and syndromes in multiple sclerosis. Mult Scler Int. 2013;2013:319201. doi: 10.1155/2013/319201. Epub 2013 Sep 17."}]}, 'descriptionModule': {'briefSummary': 'The aim of this work is to identify different pattern of Gastrointestinal and Hepatic symptoms and its Frequency among patients with Multiple Sclerosis', 'detailedDescription': 'Historically, the routine evaluation of symptoms in MS patients focused on skeletal muscle impairments that restricted mobility. Within the last two decades, symptoms such as dysphagia, bladder and bowel dysfunction, among others, have been increasingly recognized and incorporated into patient assessments \\[1-3\\]. The GI problems felt to be most common in MS patients involve deglutition and defecation and require volitional muscle coordination. This association may link the development of such GI problems to underlying MS disease progression. However, GI symptoms that are not dependent upon skeletal muscle control are common in the general population and may also be present in MS patients. More than two decades ago, Hinds and colleagues described a high prevalence of anorectal dysfunction in a large cohort of MS patients \\[4\\]. Since then, the diagnostic and clinical approach to MS care has changed dramatically and now emphasizes the early introduction of disease modifying therapies \\[5\\]. However, despite changes in MS care, anorectal dysfunction and swallowing problems continue to be an important problem for MS patients . Little is known about other GI symptoms in MS patients in this new era of pervasive use of disease modifying therapies. To address this gap in knowledge, the investigators sought to define the prevalence of GI symptoms and syndromes in a large sample of contemporary MS patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'both genders people on remission any age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- both sex 2- All patients diagnosed MS ( in recovery on DMT) according to the 2017-McDonalds criteria.\n\n 3- Pt with MS suffer from git and hepatic symptoms not explained by known cause as Hepatitis virus،metabolic disorders as Wilson . hemochromatosis,etc Drug induced , Alcohol , Git symptoms as dysphagia, vomiting,reflux\n\n 4- An informed consent will be obtained from all the patients, the study will be approved by ethical committee in faculty of Medicine Assiut University\n\nExclusion Criteria :1-patients already diagnosed with other GIT disorders before diagnosis of MS\n\n2\\_ Presence of other disorder or on medications that may affect the neurological or GIT disorders.\n\n3\\_ Patients failed to commit to the follow up visits and regular MRI scans 4\\_ Patients refused to sign the written informed consent Patients who will meet the inclusion and exclusion criteria will be assessed in the 1st visit by direct interview followed by clinical examination and neuropsychological assessments. Baseline MRI scans will be obtained at the first visit\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06770959', 'briefTitle': 'Frequency of Gastrointestinal and Hepatic Manifestations Among Patients with Multiple Sclerosis, a Clinical Hospital Based Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Frequency of Gastrointestinal and Hepatic Manifestations Among Patients with Multiple Sclerosis, a Clinical Hospital Based Study', 'orgStudyIdInfo': {'id': 'GIT symptoms in MS patients'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nayera Mohamed Refaat, master degree', 'role': 'CONTACT', 'email': 'refaatnayera@gmail.com', 'phone': '01013582879'}, {'name': 'Shady Mohamed Safwat, doctor', 'role': 'CONTACT', 'email': 'Shady.Hassan@aun.edu.eg', 'phone': '01008763141'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Nayera Mohamed Refaat Abdelhameed', 'investigatorAffiliation': 'Assiut University'}}}}