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A Pilot / Phase 2 Clinical Trial of GSL-01-001 Administered Orally for 12 Weeks Preceded by a 2 Week Screening Period in Patients Presenting with Symptoms Associated with Irritable Bowel Syndrome with code GSL-01-001
EU CTIS ID: 2024-514685-39-00
What this study is testing
To assess the effectiveness of GSL-01-001 at controlling the symptoms associated with Irritable Bowel Syndrome with diarrhea including abdominal pain, cramping, nausea, bloating, distention, diarrhea and constipation. To assess the safety of GSL-01-001 in the patient population.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >=18 <=50 years old male and female
- Ability to complete the study in compliance with the protocol; and
- Ability to understand and provide written informed consent.
- BMI >18 <40 kg/m2
- Patient has a diagnosis of IBS-D
- Has an average abdominal pain score of ≥5.5 at baseline.
You likely can't join if
- All subjects with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool, family history of colorectal cancer or inflammatory bowel disease) without colonoscopy performed at most five years before the study screening visit (as per Appendix 1 point 1).
- Use of the medications - prior (within 14 days before Visit 2) or anticipated concomitant prescription medication or OTC therapy for IBS including, but not limited to, abdominal pain medications, antibiotics, anticholinergics, antidiarrheals, antiflatulence agents, antispasmodics, chloride channel activators, bile acid sequestrants, cholinomimetics, 5-HT3 antagonists, 5-HT4 agonists, guanylate cyclase C agonists, opioid agonists or antagonists, osmotic laxatives, stimulant laxatives.
- Use prior (within 30 days of Visit 1) or anticipated concomitant use of GI antibiotics.
- Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes (Appendix 5).
- Participation in another clinical trial before 30 days prior Visit 1 (Screening) or planning participation in another clinical study during this study.
- Patients with diagnosis or history of inflammatory bowel disease (IBD), colorectal cancer, diverticulitis, ischemic colitis, microscopic colitis, bile acid diarrhea, or celiac disease.
See the full eligibility criteria
Who can join
- >=18 <=50 years old male and female
- Ability to complete the study in compliance with the protocol; and
- Ability to understand and provide written informed consent.
- BMI >18 <40 kg/m2
- Patient has a diagnosis of IBS-D
- Has an average abdominal pain score of ≥5.5 at baseline.
- If treated with any of the following medicaAons, dosing must be stable for 90 days prior to Screening and the subject must agree to maintain the same dose of medicaAon throughout the study: - Tricyclic anAdepressants, tetracyclic anAdepressants, selecAve serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs) for condiAons other than IBS pain, - Benzodiazepines or non-benzodiazepine hypnoAcs, administered at bedAme for condiAons other than IBS pain
- Patient has stable eaten habits for the past 12 weeks and is not planning to change his/her lifestyle and/or diet during the study
- Female patients if they are post-menopausal or sterilized, or if they are of childbearing potential and their pregnancy test is negative
- All patients of childbearing potential must agree to use highly effective birth control method(s) throughout the study, and for at least 30 days after receiving the last dose of study drug; females using oral contraception must have started using the medication at least 30 days prior to screening; surgical sterilization must have occurred at least 6 weeks prior to screening.
- Male patients must agree not to donate sperm for 30 days ager receiving study drug.
What rules you out
- All subjects with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool, family history of colorectal cancer or inflammatory bowel disease) without colonoscopy performed at most five years before the study screening visit (as per Appendix 1 point 1).
- Use of the medications - prior (within 14 days before Visit 2) or anticipated concomitant prescription medication or OTC therapy for IBS including, but not limited to, abdominal pain medications, antibiotics, anticholinergics, antidiarrheals, antiflatulence agents, antispasmodics, chloride channel activators, bile acid sequestrants, cholinomimetics, 5-HT3 antagonists, 5-HT4 agonists, guanylate cyclase C agonists, opioid agonists or antagonists, osmotic laxatives, stimulant laxatives.
- Use prior (within 30 days of Visit 1) or anticipated concomitant use of GI antibiotics.
- Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes (Appendix 5).
- Participation in another clinical trial before 30 days prior Visit 1 (Screening) or planning participation in another clinical study during this study.
- Patients with diagnosis or history of inflammatory bowel disease (IBD), colorectal cancer, diverticulitis, ischemic colitis, microscopic colitis, bile acid diarrhea, or celiac disease.
- Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the InvesAgator (or designee).
- Diagnosis of small intestine bacterial overgrowth (SIBO)
- Any colonic or major abdominal surgery (e.g., bariatric surgery [including gastric banding], cholecystectomy, stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). Procedures such as appendectomy, hysterectomy, cesarean section, or polypectomy are allowed if they have occurred at least 3 months prior to Visit 1 (Screening).
- Other GI diseases such as peptic ulceration, functional dyspepsia, GI bleeding, or GI inflammatory disease (e.g., esophagitis, gastritis, or duodenitis) within 6 months prior to Visit 1 (Screening).
- Pregnant, lactation or planning to become pregnant in the course of the study.
- Use of any of the following medications within 30 days prior to Visit 1 (Screening): - Opioids - The following are excluded if they are prescribed for IBS pain anticonvulsants (e.g., pregabalin or gabapenAn) - Medical or recreational marijuana, tetrahydrocannabinol (THC), cannabidiol (CBD), any other minor cannabinoid (CBG, CBDA, CBN etc.) synthetic cannabinoids, and other cannabis derivatives for any indication.
- Benzodiazepines, or non-benzodiazepine hypnotics, unless administered at bedtime for conditions other than IBS pain (stable by 90 days or not use by last 30 days).
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.