- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03262870
Gut Microbiota and Multiple Sclerosis
August 27, 2017 updated by: Azza Gama, Assiut University
Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.
Study Overview
Status
Unknown
Conditions
Detailed Description
Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.
The etiology of MS is complex and poorly understood.
Both genetic and environmental factors play a role and recent evidence suggests that gut microbiota is one of the key environmental factors.
Gut microbiota is increasingly being seen an important environmental risk factor for multiple sclerosis, and strategies to correct an imbalance in intestinal flora.The first study, "Multiple sclerosis patients have a distinct gut microbiota compared to healthy controls," published in Scientific Reports, found that people with relapsing-remitting MS have altered fecal microbiota and may have microbial dysbiosis.
People with MS had reduced levels of a protein called aryl hydrocarbon receptor circulating in their blood.Aryl hydrocarbon receptor is involved in many biological processes, including inflammation.
The researchers found that gut microbiota play a role in turning tryptophan, and amino acid found in food, into Aryl hydrocarbon receptor agonists, which act on cells of the nervous system called astrocytes and limit inflammation of the central nervous system.
Low levels of Aryl hydrocarbon receptor in multiple sclerosis patients may explain how microbial dysbiosis could be causing the condition.Increased constipation and fecal incontinence and increased gut permeability in multiple sclerosis patients, and increased occurrence of inflammatory bowel diseases in MS patients and their families suggest an important gut-central nevus system connection.Interestingly, gut bacteria can also influence the blood brain barrier integrity.
These studiesimplicate that gut microbiota may potentially be operational in predisposition to or modification of the disease course of multiple sclerosis.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted in Assiut University hospital and outpatient clinic individuals
Description
Inclusion Criteria:
- The study will included 40 cases of MS according to Diagnostic criteria of multiple sclerosis they classified into two types of Multiple sclerosis ,Relapsing-remitting MS (group 1), and Primary progressive MS, Secondary progressive MS, and Progressive relapsing MS (group 2).
Each patient was submitted to the following:
Expanded disability status scale score between 1 and 6 and functional system score.
Demographic and clinical data (Age, sex, age of onset, severity of disease, clinical symptoms and signs, Types of treatment, duration of treatment, number of attacks).
Exclusion Criteria:
- The general exclusion criteria included prior surgeries, any patients or controls currently taking antibiotics or probiotic supplements,or having a known history of disease with an disease such, rheumatoid arthritis,type-1-diabetes, and IBD, were also excluded from the study.Microbial DNA was extracted from fecal material of each sample.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Understanding the role of gut microbiota in the modification of the disease course of MS .
Time Frame: 24 month
|
24 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 4, 2018
Primary Completion (ANTICIPATED)
January 4, 2019
Study Completion (ANTICIPATED)
January 4, 2020
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
August 24, 2017
First Posted (ACTUAL)
August 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 29, 2017
Last Update Submitted That Met QC Criteria
August 27, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMAMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
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University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
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BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
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Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
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Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States