Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05045768 |
Other study ID # |
348/28-7-2021 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
February 26, 2024 |
Study information
Verified date |
February 2024 |
Source |
Evangelismos Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.