Irritable Bowel Syndrome - constipation predominant (IBS-C) Digestive System
Conditions
Interventions
Trial arms:
Participants will be randomly assigned in a 1:1:1 ratio to three treatment arms:
1. Active treatment arm 1: participants will receive study drug EBX-102-02
2. Active treatment arm 2: part
Sponsors
EnteroBiotix Limited
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 to 70 years of age, inclusive, at the time of signing the informed consent 2. Participants who: 2.1. Have a clinical diagnosis of IBS-C, as confirmed by Rome IV grading criteria (including only participants with at least moderate disease intensity by using an IBS-SSS inclusion of = 175 (recorded at both screening assessment and confirmed at the baseline entry), AND 2.2. Reported IBS-C symptom onset at least 6 months before Screening Date 3. Willing to discontinue all medications for bowel habit abnormalities (IBS-C, IBS-D, and IBS-M) after providing consent. 4. Report an average weekly worst abdominal pain intensity score = 3.0 on a 0-10 numeric scale 5. Have fewer than three (3) complete spontaneous bowel movements (CSBMs) per week recorded in DIBSS-C during the Screening assessment 6. Willing to abstain from consuming regular ‘over-the-counter’ pre- or probiotics from pharmacies or other retailers from screening through to end of follow-up 7. No clinically significant abnormalities in vital signs (blood pressure, heart/pulse rate, respiratory rate, oral temperature) determined within 28 days before first dose of study drug 8. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of study drug. 9. Participants with lactose intolerance who are on a dairy free diet or use lactase-containing products when consuming dairy may be included in the study 10. Body Mass Index within the range 17.5 to 35 kg/m2 (inclusive) 11. Contraceptive use by participants or their partners should be consistent with the requirements stipulated in the study protocol 12. Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the study protocol 13. Willing and able to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1. Diarrhoeal illness within 7 days prior to Screening based on clinical judgement 2. Infectious diarrhoea including C. difficile or diarrhoea associated with foreign travel within 12 months of screening 3. Other clinically significant chronic gastrointestinal (GI) disease, as per the opinion of the Investigator including: inflammatory bowel disease, diverticulitis (uncomplicated diverticulosis will not exclude a participant from the study), gastro-oesophageal reflux disease uncontrolled by medication, eosinophilic oesophagitis or other eosinophilic GI diseases, microscopic colitis, malabsorption syndromes e.g. coeliac disease. Further guidance and examples are provided in the study protocol. 4. Any history of malignant tumours (primary or secondary) affecting any part of the GI tract including participants with known familial colorectal cancer syndromes (e.g. Lynch) or any conditions associated with increased risk of GI cancer (e.g., familial adenomatous polyposis coli - FAP) 5. History of colectomy/ileostomy at any time 6. History of colonic perforation or fistula at any time 7. History of any malignancy within the 5 years prior to screening, excluding non-melanoma skin cancers 8. Participants with clinically significant dysphagia, or inability to ingest capsules (e.g. severe nausea, vomiting, delayed gastric emptying) as per the opinion of the Investigator, or history of ‘choking’ on capsules 9. Any significant abdominal surgical intervention with the following exceptions: appendectomy, hernia repair, laparoscopic cholecystectomy, and gynaecological and urological procedures including hysteroscopy and cystoscopy. None of these noted surgical exceptions are allowed within 12 months prior to Screening. No upper endoscopy or colonoscopy within 2 months prior to Screening. 10. History of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, regardless of current viral status and test results 11. Any autoimmune or oncologic disease requiring, or that may require, systemic treatment with steroids and/or other immunosuppressants/immunomodulators 12. Significant bleeding disorder 13. Anaphylactic food allergy 14. Clinically significant (in the investigator’s opinion) valvular heart disease or known structural defects of the heart 15. Participants with active SARS-CoV-2 infection or complications related to COVID-19 that could interfere with the conduct of the study 16. History of prior or current use of the investigational medicinal product (EBX-102-02) 17. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN) 18. Ongoing requirement for medications known to cause constipation e.g. Iron supplementation, opiates, anti-diarrhoeal agents 19. Use of any colonic enemas at any time during the study 20. Use of any prohibited medications for which a participant cannot complete the appropriate washout period 21. Use of oral or intravenous antibiotic therapy (amoxicillin, doxycycline, cephalexin, ciprofloxacin) for non-IBS indications within 7 days prior to starting the daily bowel habit or weekly global impressions questionnaire, or intended use during the study (or antibiotic therapy use [rifaximin, neomycin] for IBS within 90 days prior to starting the daily bowel habit or weekly global impressions questionnaire 22. Requirement for vasopressors 23. Have taken an investigational medicinal product (IMP) within the last 3 months or 5x the half-life of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritable bowel symptom severity measured using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) questionnaire at baseline and week 14;Incidence and type of treatment emergent adverse events (TEAEs) measured using data collected during safety monitoring assessments at screening, baseline, weeks 1, 5, 9 and 14, clinically significant abnormal vital signs at baseline, weeks 1, 5, 9 and 14 and clinically significant abnormal ECG and clinical laboratory assessments at screening and week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate measured using a composite weekly responder criterion (requiring both =30% reduction from baseline in the weekly average of daily worst abdominal pain scores AND an increase of =1 complete spontaneous bowel movement (CSBM) per week from baseline, met in =50% of planned treatment weeks) at weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactShinofa Rizan
Outcome results
None listed