Vibrant Capsule for Constipation

(Capsule Trial)

No longer recruiting at 1 trial location

Overseen By Dvora Darky

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vibrant Ltd.

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

Disqualifiers: Diverticular disease, Obstruction, IBD, others

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Vibrant capsule for individuals with chronic constipation unresponsive to other treatments. The study compares the effects of the Vibrant capsule, taken twice a week, to a placebo capsule that looks similar but lacks the active ingredient. Participants with long-term constipation who haven't found relief with other treatments might be suitable for this trial. As an unphased trial, it offers a unique opportunity for patients to explore new treatment options that might provide relief where others have not.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications that affect intestinal motility, like opiates or iron supplements, unless you've been on a stable dose of antidepressants (other than TCAs) or hormonal therapy for at least 3 months. Check with the trial team to see if your specific medications are allowed.

Is there any evidence suggesting that the Vibrant capsule is likely to be safe for humans?

Research has shown that the Vibrant Capsule is generally safe and well-tolerated by patients. In clinical trials, many participants did not experience serious side effects and found it easy to use. Studies have indicated that about 40% of patients had one more bowel movement each week compared to 23% of those taking a placebo.

The capsule treats constipation by gently vibrating to aid movement in the gut. While it is safe, it is important to take it as directed and avoid biting it before swallowing.

Overall, evidence supports the Vibrant Capsule as a safe option for those dealing with constipation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for constipation, which often rely on fiber supplements, laxatives, or stool softeners, the Vibrant Capsule offers a novel approach. This capsule uses a unique vibrating mechanism to stimulate the colon, potentially improving bowel movements without the need for traditional chemical ingredients. Researchers are particularly excited about this treatment because it offers a non-pharmacological option that might reduce the dependency on medications and their associated side effects. Additionally, its twice-weekly administration could offer a more convenient and less intrusive solution for patients.

What evidence suggests that the Vibrant capsule could be effective?

Research shows that the Vibrant Capsule, which participants in this trial may receive, effectively treats constipation. Studies have found that people using the Vibrant Capsule experienced noticeable improvements in bowel movements and stool consistency. In one study, 39.3% of participants met the main treatment goals, compared to only 22.1% of those taking a placebo. The capsule also increased the frequency of complete bowel movements and improved overall quality of life. Additionally, the treatment is considered safe for long-term use, with only a few side effects, such as diarrhea. ^{6 7 8 9 10}

Who Is on the Research Team?

Tal Malina, MBA

Principal Investigator

Vibrant Ltd.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects aged 22 years and older

Subjects with Chronic Idiopathic Constipation (CIC) according to Rome IV criteria

Subjects who have not experienced relief of their symptoms from one or more available therapies (for at least one month at recommended dose) or unable to tolerate these therapies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive Vibrant or placebo capsules twice a week for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vibrant Capsule

How Is the Trial Designed?

Group I: Active capsule Experimental Treatment 1 Intervention

The Vibrant non-biodegradable capsule administrated twice a week

Group II: Placebo Placebo Group 2 Interventions

The placebo capsule is a softgel biodegradable capsule which is visually similar to the Vibrant active capsule and administrated twice a week

Who Is Running the Clinical Trial?

Vibrant Ltd.

Lead Sponsor

Trials

10

Recruited

980+

Citations

1. gastrojournal.org gastrojournal.org/article/S0016-5085%2823%2900149-X/fulltext

Randomized Placebo-Controlled Phase 3 Trial of Vibrating ... Significant improvements were observed in the straining effort and stool consistency in patients receiving the vibrating capsule compared with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36822371/

Randomized Placebo-Controlled Phase 3 Trial of Vibrating ... A greater percentage of patients receiving the vibrating capsule achieved both primary efficacy end points compared with placebo (39.3% vs 22.1% ...

3. vibrantgastro.com vibrantgastro.com/blog/press-releases-news/vibrants-novel-drug-free-treatment-demonstrates-positive-efficacy-and-safety-results-in-adults-with-chronic-idiopathic-constipation-in-pivotal-phase-3-study

Vibrant's Novel Drug-Free Treatment Demonstrates ... The data shows that Vibrant significantly improved complete bowel movement frequency, constipation symptoms, and quality of life in adults ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.15004

The Vibrating Capsule: Safety and Tolerability in Patients ... The novel Vibrating Capsule is an orally ingested device that was recently proven to significantly improve constipation symptoms in CIC patients ...

5. journals.lww.com journals.lww.com/ctg/fulltext/9900/real_world_evidence_of_the_long_term_clinical.459.aspx

Real-World Evidence of the Long-Term Clinical Utility of a... In a community setting, the VC seems both effective and safe for long-term treatment of chronic constipation with diarrhea being notably uncommon. Abstract ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210052.pdf

DEN210052, Vibrant System, Vibrant Ltd - accessdata.fda.gov The pivotal study collected safety data for 8 weeks. • The V270 pivotal study did not include evaluation for capsule retrievals once they passed.

7. vibrantgastro.com vibrantgastro.com/clinical-data

Clinical Research Efficacy & Safety Data: Primary Endpoints. Vibrant Capsule led to one additional bowel movement in approximately 40% of patients compared with 23% of people ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40059867/

The Vibrating Capsule: Safety and Tolerability in Patients ... The Vibrating Capsule, a first in class treatment for CIC was found to be safe and well tolerated by patients in clinical trials.

9. molinamarketplace.com molinamarketplace.com/marketplace/il/en-us/Providers/-/media/316821B537ED4919AD5CAC97B47CCB5F.ashx

Vibrant (transient device for constipation) NC C25205-A FDA concludes that this device should be classified into Class II. Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of ...

10. vibrantgastro.com vibrantgastro.com/s/IFU_Physicians_A4.pdf

Physician Information For Use A Vibrant Capsule should not be ingested after its expiration date. • Avoid biting the Vibrant Capsule prior to swallowing. • Long-Term Use: The safety and ...