Actively Recruiting
Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome: a Multicentre, Randomized, Double-blind, Parallel-group, Placebo-controlled Study
Led by Devintec Sagl · Updated on 2026-04-03
330
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Irritable Bowel Syndrome with diarrhea (IBS-D) is a common gut-brain interaction disorder that significantly affects quality of life, mental health, and work productivity. Current treatments often provide only partial relief, and many patients remain dissatisfied. This research aims to evaluate the safety and effectiveness of Gelsectan®, a medical device designed to protect and restore the intestinal mucosal barrier, compared with a placebo in adults with IBS-D. Participants will receive either Gelsectan® or a placebo capsule twice daily for 8 weeks. The dosing schedule starts with two capsules in the morning and evening during the first 4 weeks, followed by one capsule twice daily for the next 4 weeks. Gelsectan® contains film-forming compounds such as Xyloglucan, Pea protein, grape seed extract, and Xylo-Oligosaccharides, which may help relieve symptoms like diarrhea, abdominal pain, bloating, and flatulence. Throughout the study, patients will complete electronic diaries recording abdominal pain and stool consistency, with assessments every 4 weeks and at the end of the 8-week treatment. The study will also monitor overall IBS symptom severity, quality of life, depression symptoms, work productivity, use of rescue therapy, and safety measures including vital signs and laboratory tests. The total study duration includes an 8-week treatment period plus a 4-week post-treatment follow-up.
CONDITIONS
Brief Title
Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Diagnosed with IBS according to Rome IV criteria, with recurrent abdominal pain at least 1 day per week in the last 3 months
- Diagnosis of IBS-D subtype with over 25% loose or watery stools and less than 25% hard stools on abnormal bowel movement days
- Negative additional tests to exclude other causes as deemed appropriate
- At least one type 6 or 7 bowel movement on at least 4 days in the last week before randomization
- Weekly average worst abdominal pain score of 3 or higher on a 0-10 scale in the week before randomization
- Completed electronic diary on at least 11 of 14 days during screening
- Willing and able to complete all study tasks
- Signed informed consent
- Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception throughout the study
You will not qualify if you...
- Significant organic, systemic, or metabolic diseases that preclude participation
- Known gastrointestinal perforation or obstruction
- Organic gastrointestinal diseases such as celiac disease, bile acid malabsorption, or inflammatory bowel diseases
- Other intestinal motility disorders like biliary dyskinesia or gastroparesis
- Major abdominal surgery within six months prior to screening (some minor surgeries allowed)
- Active or recent malignancy except certain skin cancers
- Allergy or hypersensitivity to study product ingredients
- Current use of Gelsectan® or recent use of certain IBS medications
- Use of drugs interfering with abdominal pain or stool symptoms starting from screening
- Recent use of probiotics, prebiotics, synbiotics, or rifaximin
- Major unstable psychiatric disorders or recent use of antidepressants/anxiolytics unless stable
- History or suspicion of laxative abuse, alcohol abuse, or drug addiction
- Participation in another clinical trial within 30 days
- Pregnancy, breastfeeding, or intent to become pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 8 weeks
Participants take oral capsules twice a day for 2 months. During the first 4 weeks, they take two capsules in the morning before breakfast and two capsules in the evening before dinner. For the following 4 weeks, they take one capsule in the morning and one in the evening.
Visits occur throughout the 8-week treatment period as per study schedule
Duration - 4 weeks
Participants are monitored for 4 weeks after treatment to assess ongoing effects and safety.
1 follow-up visit
Trial Site Locations
Total: 12 locations
1
University Hospitals Leuven (UZ Leuven)
Leuven, Belgium, 3000
Actively Recruiting
2
Hôpital Avicenne
Bobigny, France, 93000
Actively Recruiting
3
CHU de Rouen
Rouen, France, 76000
Actively Recruiting
4
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
5
IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, Italy, 20122
Actively Recruiting
6
AOU Federico II di Napoli
Naples, Italy, 80131
Actively Recruiting
7
Azienda Ospedale Università Padova
Padova, Italy, 35128
Actively Recruiting
8
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
9
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, Italy, 56124
Actively Recruiting
10
S. Andrea University Hospital
Roma, Italy, 00189
Actively Recruiting
11
Hospital Universitario Vall d´Hebron
Barcelona, Spain, 08035
Actively Recruiting
12
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
Research Team
M
Maria Dini
D
Daniela Salvati
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here