40 Participants Needed

SIMBA Capsule for Multiple Sclerosis

CC
Overseen ByCarlos Camara-Lemarroy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

CC

Carlos Camara-Lemarroy

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with Multiple Sclerosis (either relapsing-remitting or secondary progressive) or healthy individuals living with them. Participants must not have used antibiotics, colon cleanses, or certain other medications recently and should be able to swallow normally without risk of intestinal blockage.

Inclusion Criteria

I have been diagnosed with Multiple Sclerosis or I am a healthy individual living with someone who has MS.
I haven't taken antibiotics or done a colon cleanse in the last 2 weeks.
Written informed consent

Exclusion Criteria

I have fewer than 2 bowel movements a week.
I haven't taken drugs that affect my stomach movement or acidity in the last week.
Known swallowing disorders
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants swallow the SIMBA capsule for minimally-invasive sampling of the microbiome and metabolome in the small intestine

1 week
1 visit (in-person)

Analysis

Intestinal fluid, fecal, and blood samples are analyzed for gut microbiome, viral, and metabolomic profiles

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SIMBA Capsule
Trial Overview The SIMBA Capsule is being tested to see if it can identify unique gut microbiome patterns in the small intestine that could serve as biomarkers for Multiple Sclerosis when compared to healthy controls.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials
11
Recruited
570+

IGY Life Sciences

Collaborator

Trials
1
Recruited
60+
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