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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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
6 Previous Clinical Trials
425 Total Patients Enrolled
IGY Life SciencesUNKNOWN
Carlos Camara-LemarroyPrincipal InvestigatorUniversity of Calgary
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for individuals to join this experiment?
"The clinicaltrials.gov website confirms that this medical trial is not seeking participants at present. Initially posted on June 1st 2023 and last updated April 25th, the study does not require any further enrollees for now; however, there are 536 other trials actively enrolling patients."
Answered by AI
Is there eligibility for me to take part in this research?
"Candidates who wish to enrol in this medical trial must suffer from multiple sclerosis and be within the confines of 18-80 years old. Approximately 60 patients will join the study altogether."
Answered by AI
Do individuals aged 50 and over qualify for participation in this experiment?
"The lower and upper age limits for participation in this study are 18 years old and 80 years old, respectively. If a prospective participant falls outside of these boundaries, there are 41 studies targeting those under 18 or 385 trials recruiting senior citizens aged 65+."
Answered by AI
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