Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome

Exclusion Criteria

• •1. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiovascular, renal, neurological, endocrine, metabolic or hepatic disease) that would preclude participation in this study in the opinion of the Investigator, or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.
• •2. Known perforation and/or gastrointestinal obstruction.
• •3. Ascertained organic gastrointestinal diseases, including celiac disease, bile acid malabsorption or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
• •4. Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel syndrome.
• •5. Previous major abdominal surgery (uncomplicated appendectomy, cholecystectomy, polypectomy, inguinal hernia surgery, or caesarean section are allowed unless within six months prior to screening).
• •6. Active malignancy of any type (except for non-invasive basal or squamous cell carcinoma of the skin), or history of a malignancy other than non-invasive basal or squamous cell carcinoma of the skin. Patients with a history of malignancies that have been surgically removed with no evidence of recurrence for at least five years and no treatment prior to screening are allowed to participate in the study.
• •7. History of allergy or hypersensitivity to any of the investigational product ingredients or excipients.
• •8. Current use of Gelsectan®.
• •9. Use of loperamide or antispasmodics (i.e., direct smooth muscle relaxants, anticholinergic agents and calcium channel blockers) in the 14 days prior to randomization.
• •10. Concomitant use (starting from screening) of weak and potent opioids, 5-HT3 antagonists, such as alosetron and ondansetron, bile acid sequestrants, eluxadoline or any other drug/supplement known to significantly interfere with abdominal pain, stool frequency and consistency and/or intestinal permeability (except for those allowed as rescue therapy starting from randomization), including but not limited to corticosteroids, aminosalicylates, immunosuppressants and biologicals.
• •11. Prior and concomitant use of probiotics/prebiotics/synbiotics or rifaximin starting from 28 days prior to randomization. Other oral antibiotics and topical antibiotics are allowed.
• •12. Any major psychiatric unstable disorder, including eating disorders, and use of antidepressant or anxiolytic agents, unless used at a stable dose for at least 6 weeks prior to randomization.
• •13. History or current evidence of laxative abuse within 5 years prior to screening.
• •14. Recent history (within 12 months prior to screening) or suspicion of alcohol abuse or drug addiction.
• •15. Treatment with any investigational drug or medical device within 30 days prior to randomization, or current participation in other clinical trials or investigations.
• •16. Pregnancy or breastfeeding or intention to look for pregnancy throughout the whole study duration.