Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 9:38 AM
Study NCT ID:
NCT05045768
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postinfectious Irritable Bowel Syndrome and Gelsectan
Sponsor:
Evangelismos Hospital
Organization:
Study Overview
Official Title:
Treatment of Postinfectious Irritable Bowel Syndrome and Noninfective Irritable Bowel Syndrome With Gelsectan
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Irritable Bowel Syndrome (IBS) is one of the most common conditions diagnosed in gastroenterology practice. Acute infectious gastroenteritis represents the strongest known risk factor for IBS development; a condition known as post-infection IBS (PI-IBS). PI-IBS patients are more likely than sporadic IBS patients to exhibit a diarrhea-predominant phenotype. The investigators plan to prospectively recruit two groups of patients: patients with diarrhea-predominant post-infectious IBSand patients with diarrhea predominant classical IBS (non PI-IBS) who will be used as controls.
Patients included in the study will receive for 28 days a capsule containing Tamarind seed polysaccharide containing xyloglucan, combined with a pea protein reticulated with grape seed extractand a prebiotic, the xilooligosaccharide (Gelsectan, Devintec Sagl) twice daily.
Patients included in the study will receive for 28 days a capsule containing Tamarind seed polysaccharide containing xyloglucan, combined with a pea protein reticulated with grape seed extractand a prebiotic, the xilooligosaccharide (Gelsectan, Devintec Sagl) twice daily.
Detailed Description:
The Irritable bowel syndrome (IBS) is a functional disorder of alimentary system, which is recently considered as an erroneous gut-brain interaction. IBS is one of the most common conditions diagnosed in gastroenterology practice. Its prevalence ranges between 7-16% in western countries and is more common in females and younger individuals. Although the etiology of IBS is still obscure, its pathophysiology is dominated by a combination of both psychological factors and gastrointestinal dysfunction. Recent efforts have allowed identification of several peripheral micro-organic abnormalities. These include changes in gut microbiota, low grade mucosal inflammation, and epithelial dysfunction. Acute infectious gastroenteritis represents the strongest known risk factor for IBS development; a condition known as post-infectiousIBS (PI-IBS). According to a recent survey PI-IBS accounts for around 13% of all IBS. Today the diagnostic criteria for PI-IBS proposed by the Rome Foundation Working Team are based on the Rome IV criteria. These criteria were not part of the original Rome IV document as they were prepared after the release of Rome IV publications and need to be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. The acute infectious gastroenteritis is ideally diagnosed by stool culture (although only occasionally obtained in community subjects), validated molecular biology analyses (e.g., polymerase chain reaction) or by the presence of ≥2 of the following: fever, vomiting, or diarrhea. The investigators plan to prospectively recruit two groups of patients: patients with diarrhea-predominant post-infectious IBSand patients with diarrhea predominant classical IBS (non PI-IBS) who will be used as controls. Patients included in the study will receive for 28 days a capsule containing Xyloglucan, Pea Protein and Grape Seed Extract and a prebiotic Xylo-oligosaccharides (Gelsectan, Devintec sagl) twice daily. Drugs that might have any effect on intestinal motility or secretion will not be allowed during the study period.
Patients responding to treatment will be those in whom diarrhea disappeared, i.e. reported two or less non-watery stools emissions per day (stool of type 5 or less on the Bristol scale). Response to treatment will be assessed in the two group of patients immediately after the end of the 28-day administration of Gelsectan; however all patients will be followed for another 3 months and long term response to treatment will be assessed in that time period as well. The presence and intensity of abdominal pain and flatulence will also be measured on a seven-point Likert scale (7 very much better, 6 much better, 5 somewhat better, 4 same, 3 somewhat worse, 2 much worse, 1 very much worse). These measurements will be made in all patients immediately at the end of the 28-day administration of Gelsectan and at the end of the 3 month follow up period as well. Treatment response will be compared between the two groups using the chi squared test.
Safety and tolerability will be monitored during the entire study period through adverse events occurence.
Patients responding to treatment will be those in whom diarrhea disappeared, i.e. reported two or less non-watery stools emissions per day (stool of type 5 or less on the Bristol scale). Response to treatment will be assessed in the two group of patients immediately after the end of the 28-day administration of Gelsectan; however all patients will be followed for another 3 months and long term response to treatment will be assessed in that time period as well. The presence and intensity of abdominal pain and flatulence will also be measured on a seven-point Likert scale (7 very much better, 6 much better, 5 somewhat better, 4 same, 3 somewhat worse, 2 much worse, 1 very much worse). These measurements will be made in all patients immediately at the end of the 28-day administration of Gelsectan and at the end of the 3 month follow up period as well. Treatment response will be compared between the two groups using the chi squared test.
Safety and tolerability will be monitored during the entire study period through adverse events occurence.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: