Evaluation of the Microbiome in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844826
• Other study ID #: REB22-1771
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Nimble Science Ltd.
• Contact: Carlos Camara-Lemarroy
• Phone: (403) 944-4253
• Email: carlos.camaralemarro[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• SIMBA Capsule
Participants will swallow capsule

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Nimble Science Ltd.	IGY Life Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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