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Evaluation of the Microbiome in Multiple Sclerosis
Evaluation of the Microbiome in Multiple Sclerosis

NCT05844826

TerminatedNA

Sponsor: Nimble Science Ltd.

Conditions: Multiple Sclerosis

Interventions: SIMBA Capsule

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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
Locations (1)
  • Calgary, Alberta, Canada