Evaluation of the Microbiome in Multiple Sclerosis

A Clinical Study To Evaluate Small Intestine Microbiome In Multiple Sclerosis (MS)

Stopped earlyNot a drug-phase studyRelapsing and progressiveNCT05844826

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Financial constraints and study recruitment phase exceeded the time allotted

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • SIMBA Capsule

What it measured

Main measures

  • 16s microbiome sequencing and LC-MS metabolomic analysis will be performed on these samples to compare gut microbiome and metabolite profiles of healthy control and diagnosed MS patients

    baseline

    Blood or spinal fluid markersBladder, bowel and sexual function

  • Comparison of blood samples from Multiple Sclerosis (MS) and healthy control participants for biomarkers of inflammation, as analysed using ELISA, protenomic methods, and commercially available assays.

    baseline

    Blood or spinal fluid markers

Who could take part

Relapsing and progressive · 18 to 80

Show the full criteria

Inclusion criteria

1. Age between 18 and 60 years inclusive. 2. Have diagnosis of Multiple Sclerosis (relapsing remitting or secondary progressive for the MS cohort) or be a healthy individual living in the same household (non-MS for the healthy control cohort) 3. No antibiotics, or colon cleanses/bowel preparation in the previous 2 weeks. 4. Written informed consent

Exclusion criteria

1. Known to have swallowing disorders 2. Known disease which, in the investigator's opinion, would lead to intestinal stricture or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, diverticulitis, Crohn's disease, Ulcerative colitis, cancer diagnosis or treatment within the past year, or previous oesophageal, gastric, small intestinal, or colonic surgery. 3) Appendectomy or cholecystectomy more than 3 months prior to enrolment are acceptable). The main deciding factor would be history of obstructive symptoms in the previous 3 months prior to entry. 3. Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA); for both groups. 4. \< 2 bowel movements per week (for both groups). 5. Risk or suspect of being pregnant

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To access the small intestinal microbiome and find abnormal microbiome/metabolome signature in luminal fluid samples from small bowel in MS compared to HC that could be used as biomarkers for MS.

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History

    1. Started

      Jun 2023

    2. Main results due

      Apr 2024

    3. Finished

      Apr 2024

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