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New treatment option for Irritable Bowel Syndrome (IBS)
Official title Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT06681012
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female, age ≥18 years and ≤ 65 years.
- Positive diagnosis of IBS, according to Rome IV diagnostic criteria, namely recurrent abdominal pain, on average, at least 1 day/week in the last 3...
- 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...
You likely can't join if
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiovascular, renal, neurological, endocrine...
- Known perforation and/or gastrointestinal obstruction.
- Ascertained organic gastrointestinal diseases, including celiac disease, bile acid malabsorption or inflammatory bowel diseases (Crohn's disease...
- Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel...
- Previous major abdominal surgery (uncomplicated appendectomy, cholecystectomy, polypectomy, inguinal hernia surgery, or caesarean section are allowed...
- Active malignancy of any type (except for non-invasive basal or squamous cell carcinoma of the skin), or history of a malignancy other than...
See the full eligibility criteria
Who can join
- Male or female, age ≥18 years and ≤ 65 years.
- Positive diagnosis of IBS, according to Rome IV diagnostic criteria, namely recurrent abdominal pain, on average, at least 1 day/week in the last 3 months associated with two or more of the following criteria:
- 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.
- Positive diagnosis of IBS-D subtype based on Rome IV diagnostic criteria, i.e., more than 25% of bowel movements with a consistency of type 6 or type 7 (loose or watery stools) on the BSFS, and less than 25% of bowel...
- Negative results to any relevant additional tests or exams whenever deemed appropriate by the Investigator to exclude other disorders or causes of IBS symptoms.
- At least one type 6 or type 7 bowel movement based on the BSFS on at least 4 days within the last week prior to randomization.
- Weekly average score of 24-hours worst abdominal pain score ≥ 3 on NRS-11 in the last week prior to randomization.
- Electronic diary (e-diary) completed on at least 11 of 14 days (≥ 75%) during the screening period (i.e., 2 weeks prior to randomization).
- Willingness and capability to fulfil all tasks foreseen by the Clinical Investigation Plan (CIP).
- Signed written informed consent.
- Females of childbearing potential must have a negative urine pregnancy test (dipstick) at randomization and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective or acceptable...
What rules you out
- 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...
- 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...
- Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel syndrome.
- Previous major abdominal surgery (uncomplicated appendectomy, cholecystectomy, polypectomy, inguinal hernia surgery, or caesarean section are allowed unless within six months prior to screening).
- 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 allergy or hypersensitivity to any of the investigational product ingredients or excipients.
- Current use of Gelsectan®.
- Use of loperamide or antispasmodics (i.e., direct smooth muscle relaxants, anticholinergic agents and calcium channel blockers) in the 14 days prior to randomization.
- 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...
- 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.
- 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.
- History or current evidence of laxative abuse within 5 years prior to screening.
- Recent history (within 12 months prior to screening) or suspicion of alcohol abuse or drug addiction.
- Treatment with any investigational drug or medical device within 30 days prior to randomization, or current participation in other clinical trials or investigations.
- Pregnancy or breastfeeding or intention to look for pregnancy throughout the whole study duration.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Bobigny, France
- Rouen, France
- Bologna, BO, Italy
- Milan, Italy
- Naples, Italy
- Padova, Italy
- Pavia, Italy
- Pisa, Italy
- Roma, Italy
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Bobigny, France; Rouen, France; Bologna, BO, Italy; Milan, Italy; Naples, Italy and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.