Irritable Bowel Syndrome (IBS), subtypes IBS-C and IBS-D MedDRA version: 21.1 Level: LLT Classification code 10060849 Term: Diarrhoea predominant irritable bowel syndrome System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066868 Term: Constipation predominant irritable bowel syndrome System Organ Class: 100000004856
Conditions
Sponsors
4D Pharma Plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must meet all of the following inclusion criteria: 1. Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved ICF before any study specific evaluation 2. Males and Females between 18 and 70 years of age 3. Body Mass Index (BMI): 18-39 kg/m2 4. Having IBS-C or IBS-D as defined by Rome IV including Subtype Classification: 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 of stool • Associated with a change in form (appearance) of stool The above criteria must be met for the last 3 months with symptom onset at least 6 months prior to diagnosis. 5. Have a moderate or severe IBS symptom severity score ; =175 at the screening visit as defined by IBS-SSS. A tolerance of -10% (= an IBS-SSS score of 157.5) will be allowable at the Baseline (Visit 1). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Any of the following criteria will exclude the Subject from study participation: 1. Males or females 70 years of age 2. Have an IBS symptom severity score 39 kg/m2 4. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrine, immunological, metabolic or any condition which contraindicates, in the investigators' judgment, entry to the study) 5. Confirmed clinical diagnosis of bile acid malabsorption and / or on medication for bile acid malabsorption 6. Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study requirements 7. Patient is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or patient is receiving other investigational agent(s) 8. Have an active or recent (within 3 years) malignant disease or any concomitant end-stage organ disease. A non-melanoma skin cancer that has been adequately treated with no recurrence within 3 months of screening is not excluded. 9. Females who are pregnant or breast feeding 10. Refusal to use acceptable methods of birth control (true abstinence, sterilisation, birth control pills, injections or contraceptive implants) for women of child bearing potential while on treatment and following completion of 2 menstrual cycles/ months after the last dose of study treatment. For Males, a barrier method of birth control from randomisation until the Follow-Up visit, unless vasectomised 11. Use of antibiotics within 30 days of screening 12. Use of systemic steroids within 30 days of screening 13. Change in dose or introduction of an antipsychotic within the last month 14. Have suffered from an uncontrolled or current major psychiatric disorder 15. Clinically diagnosed Lactose intolerance 16. Clinically diagnosed Coeliac disease 17. Change of diet e.g. FODMAP, gluten-free within last 3 months 18. Those > 50 will be excluded if their diagnosis of IBS is recent (<12 months) and if they have not had a sigmoidoscopy or colonoscopy within previous 5 years. 19. Any GI related abdominal surgery other than hernia repair or appendectomy. Cholecystectomy more than 6 months previously is not an exclusion 20. Subjects taking prucalopride 21. Known HIV infection, or hepatitis A, B, or C active infection 22. Subjects with abnormal laboratory values at screening deemed by the investigator to be clinically significant 23. Subjects who have taken commercially available probiotics within the last month (30 days prior to randomisation) 24. Subjects with known or suspected hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 25. Subjects taking guanylate cyclase agonists; such as linaclotide and lubiprostone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess the efficacy of repeated twice daily doses of Blautix™ >1E10 MPN for 8 weeks in adult subjects with either IBS-C or IBS-D ;Secondary Objective: The secondary objectives of the trial is to assess the safety of repeated twice daily doses of Blautix™ >1E10MPN for 8 weeks in adult subjects with either IBS-C or IBS-D;Primary end point(s): The primary efficacy endpoint is whether the subject is an overall responder. A subject is an 'overall responder' if they have reported an improvement in their weekly (Cohort specific) symptoms (abdominal pain intensity and stool frequency or consistency) for > 50% of the treatment period (in this case 4 out of 8 weeks).;Timepoint(s) of evaluation of this end point: On-going throughout the 8 week duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: - Subject global assessment of relief - Stool consistency /Stool frequency - IBS-QOL - IBS-SSS - HADS Exploratory Endpoints - Microbiota diversity and stability - Metabolomics - Cytokine analysis Safety Endpoints - Incidence, nature, severity, relatedness, seriousness, expectedness and outcome of adverse events - Haematology and blood chemistry assessments - Vital signs;Timepoint(s) of evaluation of this end point: On-going throughout the 8 week duration of the study | — |
Countries
Ireland, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trials Department
4D Pharma Plc
Outcome results
None listed