Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C (RELAX)

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Devintec Sagl
Updated on 30 September 2022

Summary

Irritable bowel syndrome (IBS) is a common functional bowel disorder that imposes a considerable burden on health-related quality of life (QOL) worldwide. Irritable Bowel Syndrome (IBS) is a common digestive disorder affecting 7-21% of the general population. IBS with predominant constipation (IBS-C) is a subtype of IBS that accounts for more than a third of the IBS diagnosed.

The study Sponsor, Devintec SAGL, presents GA-AT0119, which acts by forming a mechanical barrier on the intestinal mucosa thanks to xyloglucan and pea proteins avoiding the increased intestinal permeability, bacterial invasion to intestinal tissues, and subsequent intestinal inflammation. The formulation of GA-AT0119 is completed with chia seed powder which provides a laxative effect by retaining water in the intestine increasing stool bulk and accelerating fecal transit.

There is increasing evidence that the pathophysiology of IBS is multifaceted involving mucosal inflammation, visceral hypersensitivity, microbial dysbiosis, dietary factors, and altered intestinal permeability (IP). Several studies have shown increased intestinal permeability in patients with irritable bowel syndrome. Serum zonulin, a biomarker of impaired increased permeability, is increased in patients' constipation-predominant irritable bowel syndrome compared to a healthy population and the levels are comparable to celiac disease.

Description

Each subject will be asked to sign the Informed Consent Form (ICF). The patients diagnosed with IBS-C will be randomized in 1:1 ratio. The treatment will be administrated according to the approved leaflet and study procedures. Eligible patients will be randomized to receive either GA-AT0119 or Placebo. Patients will be treated according to the approved leaflet. The study subjects will return at day 7, 15 and day 28 for evaluation. Each subject will undergo a washout period of 28 days. At Day 56 each subject will be evaluated and will receive the crossover therapy line and start administration. Subject will be evaluated at Day 84 at the end of the crossover period. Patients will be evaluated for constipation symptoms, global assessment for tolerability, safety. Each subject will receive a diary where bowel frequency, type and transit time will be completed during product administration. From visit 2 to visit 6, patients will be evaluated for treatment adherence and clinical symptoms recurrences. Each subject will complete 2 additional phone follow-ups Visit for safety reporting and clinical symptoms recurrences according to protocol. During the follow-up visits subject will be evaluated also by using Likert scale for Abdominal Pain and discomfort, Sickness Impact Profile score, IBS-VAS scale and IBS-QoL.

Details
Condition Irritable Bowel Syndrome With Constipation (IBS-C)
Treatment Arm A, Arm B
Clinical Study IdentifierNCT05240521
SponsorDevintec Sagl
Last Modified on30 September 2022

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note