NCT05240521

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

A Double-Blind, Placebo-Controlled, Crossover-Over Clinical Trial Investigating the Efficacy and Safety, Tolerability of GA-AT0119 in the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Devintec Sagl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

Type	Name	Description
OTHER	ARM A	30 IBS-C patients will receive GA-AT0119 for 28 days, followed by a washout period of 28 days and Placebo for another 28 days
OTHER	ARM B	30 IBS-C patients will receive Placebo for 28 days, followed by a washout period of 28 days and GA-AT0119 for another 28 days

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2022-02-15
• Last updated: 2022-02-15

Locations

4 sites across 1 country: Bulgaria