Evaluation of the Microbiome in Multiple Sclerosis

NCT05844826 | Terminated DMC

• 1 other identifier: REB22-1771
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

  Comparison of luminal fluid samples from the small bowel of MS and healthy control participants will allow us to find abnormal metabolomic signatures which can be used as biomarkers for MS.

  baseline

• 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.

  Comparison of blood samples from Multiple Sclerosis (MS) and healthy control participants will aid in quantification of markers of inflammation and markers of intestinal function.

  baseline

Study Arms (1)

Single Arm

EXPERIMENTAL

Participant swallows and retrieves capsule in stool. Intestinal fluid samples collected by SIMBA capsules from the MS and HC participants, along with a fecal and blood samples, will be used for gut microbiome, viral and metabolomic analysis.

Device: SIMBA Capsule

Interventions

SIMBA Capsule DEVICE

Participants will swallow capsule

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 60 years inclusive.
• 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)
• No antibiotics, or colon cleanses/bowel preparation in the previous 2 weeks.
• Written informed consent

You may not qualify if:

• Known to have swallowing disorders
• 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.
• 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.
• \< 2 bowel movements per week (for both groups).
• Risk or suspect of being pregnant

Sponsors & Collaborators

• Nimble Science Ltd.: lead
• IGY Life Sciences: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Carlos Camara-Lemarroy

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: June 26, 2023
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)