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.
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Change from baseline in Subjective Symptom Improvement assessed through Likert scale (Discomfort, Bloating Abdominal Pain) at day 7, 15, 28, 56, 84,114,144
Timeframe: 144 days
Change from baseline in BMI assessed at Day 7,15, 28, 56,84
Timeframe: 84 days
Change from baseline in stool consistency will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144, through the Bristol Stool Scale.
Timeframe: 144 days
Change from baseline score in IBS-QoL questionnaire (Information Sheet on the Irritable Bowel Syndrome - Quality of Life Measure) at Day 7, 15, Day 28 and Day 56, Day 84, Day 114, Day 144
Timeframe: 144 days
Change of Sickness Impact Profile score from Baseline to Day 28 and day 56, day 84, Day 114, Day 144
Timeframe: 144 days
Change from Baseline (Day 0) to Day 7, 15, 28, 56 in Zonuline test
Timeframe: 56 days
Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Patient Journal Daily on each symptom
Timeframe: 7 days
Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (The Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Investigator at Day 15, Day 28 and Day 56, Day 84, Day 114, Day 144
Timeframe: 144 days
Number of AE occurrence
Timeframe: 144 days
% of participants with withdrawal due to AE
Timeframe: 144 days
Change from baseline in waist circumference assessed at Day 7,15, 28, 56,84
Timeframe: 84 days
Change from baseline in number of stools will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144
Timeframe: 144 days