SIMBA Capsule for Multiple Sclerosis

Overseen By Carlos Camara-Lemarroy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nimble Science Ltd.

Must not be taking: Opioids, Prokinetics, Anticholinergics, others

Disqualifiers: Swallowing disorders, Crohn's, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the gut microbiome—the community of bacteria and other microorganisms in the intestines—differs in people with Multiple Sclerosis (MS) compared to healthy individuals. Participants will swallow a special capsule, the SIMBA Capsule, which collects samples from the intestines to help researchers identify unique markers that could indicate MS. This trial suits those diagnosed with relapsing-remitting or secondary progressive MS, or healthy individuals living with them, provided they haven't recently taken antibiotics or other specific medications and don't have certain digestive issues. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to new insights into MS.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that affect gut movement or acidity, like opioids, laxatives, or antacids, a week before joining the trial.

What prior data suggests that the SIMBA Capsule is safe for accessing the small intestinal microbiome?

Research has shown that the SIMBA Capsule is a promising tool for collecting samples from the small intestine. In studies, it successfully gathered intestinal fluids accurately, demonstrating its effectiveness for its intended purpose.

Regarding safety, the SIMBA Capsule has been used without major issues. Designed to be swallowed and then naturally passed in the stool, it has been safely used in trials. Available data report no serious side effects or problems.

The trial phase is labeled as "Not Applicable," focusing on testing the device's sample collection rather than treating a disease. This usually indicates that the capsule's safety is well-understood and it is generally well-tolerated.

Prospective participants should discuss any concerns with the study team, who can provide detailed information about what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for multiple sclerosis, which typically involve oral medications, injectables, or infusions that modify the immune response, the SIMBA Capsule takes a unique approach. This treatment gathers intestinal fluid samples directly from the gut to analyze the microbiome and metabolome. Researchers are excited because this method could offer new insights into the disease's gut-related factors, potentially paving the way for more targeted therapies that address MS at its root cause.

What evidence suggests that the SIMBA Capsule is effective for accessing the small intestinal microbiome in multiple sclerosis?

Research has shown that the SIMBA Capsule effectively collects samples from the small intestine, achieving a 97.2% success rate in a study using X-ray tracking. Understanding the gut microbiome, the community of tiny organisms in the intestines, might help uncover clues for Multiple Sclerosis (MS). Although the SIMBA Capsule does not treat MS, it could offer valuable insights into the disease. This makes it an important tool for exploring new ways to understand and manage MS. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Written informed consent

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.

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.

Risk or suspect of being pregnant

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?

Group I: Single Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials

11

Recruited

570+

IGY Life Sciences

Collaborator

Trials

1

Recruited

60+

Citations

1. withpower.com withpower.com/trial/phase-sclerosis-5-2023-b0592

SIMBA Capsule for Multiple Sclerosis · Info for Participants This trial is for adults aged 18-60 with Multiple Sclerosis (either relapsing-remitting or secondary progressive) or healthy individuals living with them.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05844826?cond=multiple+sclerosis

Evaluation of the Microbiome in Multiple Sclerosis An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. researchgate.net researchgate.net/publication/379547356_Spatially_and_Temporally_Precise_Microbiome_Profiling_in_the_Small_Intestine_using_the_SIMBA_Capsule_with_X-ray_tracking

Spatially and Temporally Precise Microbiome Profiling in ... This present study aims to demonstrate the sampling quality and efficacy of the SIMBA capsules in both healthy patients and those with altered gut motility with ...

4. frontiersin.org frontiersin.org/journals/microbiomes/articles/10.3389/frmbi.2024.1321624/full

Spatially and temporally precise microbiome profiling in the ... In the clinical study, the SIMBA capsule showed a remarkable ability to collect samples from the small intestine using the multiple X-ray tracking method, 97.2 ...

5. ctv.veeva.com ctv.veeva.com/study/the-digestion-of-protein-powders-in-healthy-participants-using-simba-and-limba-capsule

The Digestion of Protein Powders in Healthy Participants ... Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA/LIMBA capsules and PPI ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06394687/the-digestion-of-protein-powders-in-healthy-participants-using-simba-and-limba-capsule

The Digestion of Protein Powders in Healthy Participants ... Proton pumpinhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respectedbefore swallowing the SIMBA/LIMBA capsules and PPI ...

7. researchgate.net researchgate.net/publication/382129691_Spatially_and_temporally_precise_microbiome_profiling_in_the_small_intestine_using_the_SIMBA_capsule_with_X-ray_tracking

Spatially and temporally precise microbiome profiling in ... Conclusions: The SIMBA capsule reliably captures and preserves SI luminal fluid in a clinically relevant context that is suitable for multi- ...