Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

(Capsule Trial)

Recruiting at 1 trial location

Overseen By Dvora Darky

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vibrant Ltd.

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a pill called Vibrant Capsule to help people with long-term constipation. Participants will not use other constipation treatments during the trial. The goal is to find out if the Vibrant Capsule can safely and effectively improve bowel movements.

Research Team

Tal Malina, MBA

Principal Investigator

Vibrant Ltd.

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Vibrant Capsule

Participant Groups

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+