Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDevintec Sagl
About this trial
Irritable Bowel Syndrome (IBS) is one of the major Disorders of Gut-Brain Interaction (DGBI) and the most frequent reasons for referral to both primary care providers and gastroenterologists.IBS is not a life-threatening disease, but imposes a significant burden on society, entailing a decrease in patients' Quality of Life (QoL), elevated rates of psychological comorbidities and loss of work productivity, which might be the greatest in subjects with IBS-D, for whom the fear of incontinence in a social situation can be especially debilitating. Moreover, IBS is associated with significant direct and indirect healthcare costs and has a considerable socioeconomic impact on society.
Treatment strategy for IBS is usually based on predominant symptoms and their severity, and requires a strong patient-physician relationship, as well as both non-pharmacological and pharmacological approaches. Lifestyle interventions, such as dietary modifications, physical activity and lifestyle adjustments, and stress reduction/psychological therapy represent the most important initial non-pharmacological clinical approach for IBS patients, especially for those with mild disease. First-line pharmacological options for IBS-D include antidiarrheals, mainly loperamide, to control diarrhoea, as well as antispasmodic drugs to relieve IBS symptoms, in particular abdominal pain. Second-line therapies indicated for the treatment of global IBS-D symptoms include rifaximin, 5-Hydroxytryptamine (5-HT)3 receptor antagonists (alosetron, ondansetron and ramosetron) and eluxadoline. Other treatments recommended in patients with IBS-D consist of Tricyclic Anti-Depressants (TCAs) and bile acid sequestrants.
Notably, management of patients with IBS is challenging since diagnosis and treatment could require several therapeutical strategies with often partial and unsatisfactory results. Indeed, most patients with IBS are dissatisfied with their current therapy and 34% report no symptom control, according to the IBS Global Impact Report of 2018.
At present, there is a growing interest in therapeutic approaches for IBS-D aimed at improving intestinal barrier integrity for a more efficient control of symptoms, considering that an intestinal epithelial barrier dysfunction and mucosal immune activation have been suggested as a central mechanism in IBS-D pathophysiology. In this perspective, film-forming agents capable of protecting the intestinal mucosal barrier, such as Xyloglucan (XG) and Pea protein may represent a valid alternative therapeutic option for the management of IBS-D.
Gelsectan® is a CE-marked medical device under the European Union (EU) Medical Device Regulation (MDR) 2017/745, whose classification under the MDR is class III. Gelsectan® contains XG, Pea protein, grape seed extract, and Xylo-Oligosaccharides (XOS) and is indicated for symptomatic relief and prevention of chronic or relapsing diarrhoea, abdominal tension, pain, bloating and flatulence, as well as protection and restoration of intestinal mucosal function. Based on previous non-clinical studies and two clinical investigations, Gelsectan® seems to be safe and exert a protective action on the intestinal mucosa, mediating the restoration of intestinal permeability and the improvement of gastrointestinal symptoms associated with IBS-D. In particular, a 28-day treatment with Gelsectan® significantly reduced IBS-D-associated diarrhoea, abdominal pain and bloating, with no related adverse events in a randomized, placebo-controlled, cross-over clinical study. Moreover, Gelsectan® treatment for 6 months was generally safe and effective in improving IBS severity, diarrhoea and bowel habit, as well as pain and bloating, in a recent multicentre, open-label, prospective, observational study. Of note, Gelsectan® was also mentioned in the recent clinical practice guidelines on IBS-D and functional diarrhoea of the United European Gastroenterology (UEG) and the European Society for Neurogastroenterology and Motility (ESNM), and a recent consensus on IBS conducted by a panel of Belgian gastroenterologists.
With these premises, the present study aims to further assess the performance and safety of Gelsectan® within the scope of its intended purpose, compared with placebo, on overall abdominal pain and symptoms in patients with IBS-D in a randomized, double-blind, parallel-group clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, age ≥18 years and ≤ 65 years.
related to defecation
associated with a change in frequency stool
associated with a change in form (appearance) of stool The above criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
Disqualifiers
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.
Known perforation and/or gastrointestinal obstruction.
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).
Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel syndrome.
Trial design
Design model
Parallel
Treatments tested in this trial
Gelsectan®
DeviceOral capsules are to be taken twice a day for 2 months (two capsules in the morning before breakfast and two capsules in the evening before dinner during the first 4 weeks of treatment; one capsule in the morning and one in the evening during the following 4 weeks of treatment).
Placebo
DrugOral capsules are to be taken twice a day for 2 months (two capsules in the morning before breakfast and two capsules in the evening before dinner during the first 4 weeks of treatment; one capsule in the morning and one in the evening during the following 4 weeks of treatment).
Treatment groups
330 Participants
are divided into 2 treatment groupsGroup A: Gelsectan®Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effect of Gelsectan® on the composite response rate for abdominal pain and stool consistency over the 8-week treatment period, at the end of treatment, in patients with IBS-D, according to Rome IV criteria.
Proportion of composite responders over 8 weeks determined at the End of Treatment. A composite responder is defined as a patient who meet the following criteria for at least 50% of the 8-week treatment period: * Pain response criteria: reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline, measured with the 11-point Numeric Rating Scale (from 0=none to 10=worst possible pain) AND * Stool consistency response criteria: reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline, measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces). A patient needs to fulfil both aforementioned response criteria for abdominal pain and stool consistency in the same week to be considered a responder for that week.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Effect of Gelsectan® on overall IBS-D symptoms: composite response rate for abdominal pain and stool consistency over 4-week intervals
Proportion of composite responders over each 4-week intervals. A composite responder is defined as a patient who meet the following criteria for at least 50% of the 8-week treatment period: * Pain response criteria: reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline, measured with the 11-point Numeric Rating Scale (from 0=none to 10=worst possible pain) AND * Stool consistency response criteria: reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline, measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces). A patient needs to fulfil both aforementioned response criteria for abdominal pain and stool consistency in the same week to be considered a responder for that week.
Time frame
From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period2
Effect of Gelsectan® on overall IBS-D symptoms: Proportion of pain responders
Proportion of pain responders, defined as patients who meet the pain response criteria (i.e., reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline) for at least 50% of the observation period. The standard 11-point Numeric Rating Scale (NRS-11) (from 0=none to 10=worst possible pain imaginable) will be used for the measure of pain.
Time frame
From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period3
Effect of Gelsectan® on overall IBS-D symptoms: Proportion of stool consistency responders
Proportion of stool consistency responders, defined as patients who meet the stool consistency response criteria (i.e., reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline) for at least 50% of the observation period. Stool consistency will be measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces).
Time frame
From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period4
Effect of Gelsectan® on overall IBS-D symptoms: Mean 24-hour worst abdominal pain score
Mean 24-hour worst abdominal pain score, as self-assessed by patients daily up to Week 12 using the Numeric Rating Scale (NRS-11) (from 0=none to 10=worst possible pain imaginable)
Time frame
From enrollment to the end of the 12 weeks study periodOther outcomes
1
Intestinal permeability: percentage fractional excretion of lactulose, mannitol and sucralose after triple sugar test
Changes in the percentage fractional excretion of lactulose, mannitol and sucralose after triple sugar (lactulose, mannitol and sucralose) test (patients' urine samples)
Time frame
From enrollment to the end of treatment at 8 weeks2
Intestinal permeability: Lactulose/Mannitol Ratio and Sucralose/Mannitol Ratio after triple sugar test
Changes in Lactulose/Mannitol Ratio and Sucralose/Mannitol Ratio in urine samples measured by Gas Chromatography-Mass Spectrometry (GC-MS) after triple sugar (lactulose, mannitol and sucralose) test (patients' urine samples)
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov