Irritable bowel syndrome (IBS) Digestive System
Conditions
Interventions
EBX-102-02 is a gastro-resistant hard hydroxypropyl methylcellulose (HPMC) capsule containing communities of dried, intestinal microorganisms derived from rigorously screened pooled human stool sample
Sponsors
EnteroBiotix Limited
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide informed consent 2. Male or female aged = 18 years up to 70 years 3. A clinical diagnosis of IBS-C or IBS-D, as confirmed by Rome IV grading criteria, excluding patients with mild disease by using an IBS-SSS inclusion of = 175 4. Willing to discontinue all medications for bowel habit abnormalities after providing consent 5. 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 6. If women of childbearing potential (WOCBP), subjects must have a negative serum pregnancy test at screening, a negative urine pregnancy test at randomisation and must be willing to use a highly effective method of birth control for the duration of the study. Acceptable methods of contraception: 6.1. Hormonal contraception associated with inhibition of ovulation 6.2. Intrauterine device (IUD) 6.3. Intrauterine hormone-releasing system (IUS) 6.4. Bilateral tubal occlusion 6.5. Vasectomised partner 6.6. Sexual abstinence, in line with the preferred and usual lifestyle of the subject Note: Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal, and condom with spermicide, are not considered a highly effective method of contraception for female subjects of childbearing potential. 7. If male, subjects must be prepared to use reliable barrier method contraception and a second method such as spermicide for the duration of the study unless surgically sterile
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding 2. Planned surgery requiring general anaesthetic during the course of the study 3. Participants who are planning to significantly change their diet (e.g. weight loss programme, becoming vegetarian) during the study period. Patients established on a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet can continue without changes to it 4. Confirmed diagnosis of mixed type IBS (IBS-M), or unclassified IBS (IBS-U) 5. In IBS-C subjects: diarrhoea within 7 days prior to screening 5.1. If possible infective diarrhoea, then wait 3 weeks before starting bowel habit diary 6. In IBS-D subjects 6.1. Nocturnal diarrhoea 6.2. BSS type 7 on more than 5 days per week 6.3. Diarrhoea associated with foreign travel in the 4 weeks prior to screening 7. Other chronic gastrointestinal (GI) disease including: 7.1. Inflammatory bowel disease 7.2. Diverticulitis 7.3. Malabsorption syndromes e.g. lactose intolerance (with proven lactase deficiency) 8. Any history of malignant tumours (primary or secondary) affecting any part of the GI tract 9. History of colectomy/ileostomy at any time 10. History of colonic perforation or fistula 11. History of any malignancy within the 5 years prior to screening, excluding non-melanoma skin cancers 12. Conditions associated with increased risk of GI cancer, e.g. familial adenomatous polyposis coli 13. Abdominal surgical intervention except for appendectomy, hernia repair, and gynaecological and urological procedures 14. Known lactulose intolerance 15. Ongoing requirement for medications known to cause constipation e.g. Iron supplementation, opiates or diarrhoea e.g. antacids, non-steroidal anti-inflammatory drugs (NSAIDs) 16. Use of any prohibited medications for which a participant cannot complete the appropriate washout period 17. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5x upper limit of normal (ULN) 18. History of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, regardless of current viral status and test results 19. Use of systemic antibiotics within 7 days prior to screening, or intended use during the study 20. Faecal microbiota transplantation (FMT) within the past 12 months 21. History of sensitivity to any of the study drug components, or a history of drug allergy that in the opinion of the Investigator contraindicates study participation 22. Participants with dysphagia, or inability to ingest capsules (e.g. severe nausea, vomiting, delayed gastric emptying) or history of ‘choking’ on capsules 23. Have taken an IMP within the last 3 months 24. Planned or active participation in any other study with an IMP 25. Any autoimmune or oncologic disease requiring, or that may require, systemic treatment with steroids and/or other immunosuppressants/immunomodulators 26. Significant bleeding disorder 27. Anaphylactic food allergy 28. Requirement for vasopressors 29. Valvular heart disease or known structural defects of the heart 30. Clinically significant medical or surgical history or any condition that could interfere with study participation or confound the assessments in the opinion of the study Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 14/05/2026: Incidence and type of adverse events (AEs) measured using data collected during safety monitoring assessments at baseline (dosing 1) and weeks 1 (dosing 2), 3 (follow-up 1) and 7 (final follow-up), clinically significant abnormal vital signs at baseline and weeks 1, 3 and 7, and clinically significant abnormal ECG and clinical laboratory assessments at week -1 (pre-treatment) and week 7 Previous primary outcomes: Incidence of adverse events (AEs) and safety data (including vital signs, physical examinations and laboratory test results) up to and including 6 weeks post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 14/05/2026: 1. Irritable bowel symptom severity measured using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) questionnaire at baseline and weeks 1, 3 and 7 2. Change in symptoms of constipation measured using Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline and weeks 1, 3 and 7 3. Change in stool consistency measured using the Bristol Stool Scale at baseline and weeks 1, 3 and 7 4. Change in stool frequency and other symptomatology (i.e. severity of pain) at baseline and weeks 1, 3 and 7 Previous secondary outcomes: The following secondary outcome measures will be assessed up to and including 6 weeks post-treatment: 1. Change in IBS-C symptomatology measured on the IBS Symptom Severity Score (IBS-SSS). 2. Change in responses to Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire 3. Change in stool consistency measured on the Bristol Stool Scale 4. Change in stool frequency and other symptomatology measured by a bowel habit diary 5. Change in fermentation profiles, total gas production, and small intestinal bacterial overgrowth in biomarker breath test measurements 6. Taxonomic microbiome analysis 7. Change in Quality of Life scores measured on the IBS Quality of Life questionnaire (IBS-QOL) 8. Change in Hospital Anxiety and Depression score 9. Requirement for rescue medication 10. Metabolite analysis: SCFAs and BAs in stool | — |
Countries
United Kingdom
Contacts
Public ContactShinofa Rizan
Outcome results
None listed