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

NCT05240521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-02-15

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions

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

Sponsors & Collaborators

  • CEBIS International

    collaborator OTHER

  • Devintec Sagl

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240521 on ClinicalTrials.gov