NCT05240521: RELAX

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

Status unknown NA Last updated 15 February 2022

What this trial tests

NA trial testing ARM A in Irritable Bowel Syndrome With Constipation (IBS-C) in 60 participants. Status unknown.

Timeline

1 November 2021

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	Devintec Sagl
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 November 2021
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	4 locations across Bulgaria

Drugs / interventions tested

• ARM A
• ARM B

Conditions studied

• Irritable Bowel Syndrome With Constipation (IBS-C) — all drugs for Irritable Bowel Syndrome With Constipation (IBS-C) →

Sponsor

Devintec Sagl

Who can join

18 and older, any sex, with Irritable Bowel Syndrome With Constipation (IBS-C). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.