CClinicalTrials.gg
Status unknownNCT03262870Updated Aug 29, 2017

Gut Microbiota and Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Assiut University. Status unknown. Open to participants aged 25 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
25 Years to 40 Years
Sex
All
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Study summary

Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.

Read the 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.

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Conditions studied

  • Multiple Sclerosis
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Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients admitted in Assiut University hospital and outpatient clinic individuals

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Understanding the role of gut microbiota in the modification of the disease course of MS .

    Time frame: 24 month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03262870
Lead sponsor
Assiut University
Responsible party
Azza Gama (Dr, Assiut University) — Principal investigator
First posted
Aug 25, 2017
Start date
Jan 4, 2018 (estimated)
Primary completion
Jan 4, 2019 (estimated)
Completion
Jan 4, 2020 (estimated)
Last update
Aug 29, 2017

Study contacts

Eman Khadr, Professor
Contact
Emankhadr99@yahoo.com
01005850632

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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