Evaluation of the Microbiome in Multiple Sclerosis

NCT ID: NCT05844826

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2024-04-24

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.

Detailed Description

Participants will be swallowing the SIMBA capsule which allows for minimally-invasive sampling of the microbiome and metabolome deep in the small intestine. Researchers will use the capsule samples to access the small intestinal microbiome and find abnormal metabolomic signatures in luminal fluid samples from the small bowel in Multiple Sclerosis (MS) patients compared to healthy control.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Arm

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.

Group Type: EXPERIMENTAL

SIMBA Capsule

Intervention Type: DEVICE

Participants will swallow capsule

Interventions

SIMBA Capsule

Participants will swallow capsule

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IGY Life Sciences

UNKNOWN

Sponsor Role: collaborator

Nimble Science Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Camara-Lemarroy

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB22-1771

Identifier Type: -

Identifier Source: org_study_id