SIMBA Capsule for Multiple Sclerosis

N/A

Recruiting

Led By Carlos Camara-Lemarroy

Research Sponsored by Nimble Science Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the bacteria and metabolism in the small intestine of people with and without multiple sclerosis, to find new biomarkers to help diagnose it.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified for the SIMBA Capsule, but risks may include those typical of ingesting capsules such as discomfort or complications if there's a swallowing disorder or intestinal obstruction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 blood samples from Multiple Sclerosis (MS) and healthy control participants for biomarkers of inflammation, as analysed using ELISA, protenomic methods, and commercially available assays.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out