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Microbiome Modulator
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
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.
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Who is running the clinical trial?
Nimble Science Ltd.Lead Sponsor
10 Previous Clinical Trials
505 Total Patients Enrolled
IGY Life SciencesUNKNOWN
Carlos Camara-LemarroyPrincipal InvestigatorUniversity of Calgary
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fewer than 2 bowel movements a week.I am between 18 and 60 years old.I haven't taken drugs that affect my stomach movement or acidity in the last week.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.I don't have a history of diseases that could block my intestines.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.