MS (Multiple Sclerosis)NCT06770959
Frequency of Gastrointestinal and Hepatic Manifestations Among Patients with Multiple Sclerosis, a Clinical Hospital Based Study
An observational study of MS (Multiple Sclerosis), run by Assiut University.
Trial summary
The aim of this work is to identify different pattern of Gastrointestinal and Hepatic symptoms and its Frequency among patients with Multiple Sclerosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MS (Multiple Sclerosis)
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: both genders people on remission any age
Who may be able to join
- 1- both sex 2- All patients diagnosed MS ( in recovery on DMT) according to the 2017-McDonalds criteria.
- 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
- 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
- Exclusion Criteria :1-patients already diagnosed with other GIT disorders before diagnosis of MS
- 2 Presence of other disorder or on medications that may affect the neurological or GIT disorders.
- 3 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
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this work is to identify different pattern of Gastrointestinal and Hepatic symptoms and its Frequency among patients with Multiple Sclerosis
Read the detailed description
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
- Conditions
- MS (Multiple Sclerosis)
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Prevalence of git and hepatic manifestation in people with MS and its relations to MS treatment
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MS (Multiple Sclerosis)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayera Mohamed Refaat Abdelhameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770959
- Sponsor's protocol ID
- GIT symptoms in MS patients
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24163768
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Gastrointestinal and Hepatic Manifestations Among Patients with Multiple Sclerosis, a Clinical Hospital Based Study
- ClinicalTrials.gov ID
- NCT06770959
- Acronym / sponsor ID
- GIT symptoms in MS patients
- Conditions
- MS (Multiple Sclerosis)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this work is to identify different pattern of Gastrointestinal and Hepatic symptoms and its Frequency among patients with Multiple Sclerosis
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- both genders people on remission any age
Key inclusion criteria (7 listed)
- 1- both sex 2- All patients diagnosed MS ( in recovery on DMT) according to the 2017-McDonalds criteria.
- 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
- 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
- Exclusion Criteria :1-patients already diagnosed with other GIT disorders before diagnosis of MS
- 2 Presence of other disorder or on medications that may affect the neurological or GIT disorders.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of Prevalence of git and hepatic manifestation in people with MS and its relations to MS treatment
Time frame: 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background: PubMed 24163768Levinthal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of MS (Multiple Sclerosis), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nayera Mohamed Refaat, master degree (01013582879, refaatnayera@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Prevalence of git and hepatic manifestation in people with MS and its relations to MS treatment (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.