A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Blautix; Placebo
Intervention description: Blautix is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen was two capsules two times per day for the duration of the treatment period.; Placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blind trial design
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: constipation; diarrhea

Summary:

      A study to evaluate the effectiveness of oral doses of Blautix in adult participants with
      irritable bowel syndrome (IBS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee
             (IEC) approved informed consent form before any study specific evaluation

          2. Males and Females between 18 and 70 years of age

          3. Body Mass Index (BMI): 18-39 kg/m^2

          4. Having IBS-C or IBS-D as defined by Rome IV* including Subtype Classification as
             defined in Table 2

             * 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

          5. Have a moderate or severe IBS symptom severity score (> 175) as defined by IBS-SSS

        Table 2:

        IBS -C Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal
        pain score of > 3.0 on a 0 to 10-point scale And Stool Frequency: more than 25% of bowel
        movements with a consistency of Type 1 or Type 2 Bristol stool chart and less than 25% of
        bowel movements with Bristol stool form Type 6 or Type 7. Participants must have fewer than
        3 complete spontaneous bowel movements (CSBMs) within a one week period (7 days)

        IBS-D Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal
        pain score of > 3.0 on a 0 to 10-point scale And Stool Consistency: more than 25% of bowel
        movements with a consistency of Type 6 or Type 7 Bristol stool chart and less than 25% of
        bowel movements with Bristol stool form Type 1 or Type 2.Participants must have at least
        one Type 6 or Type 7 bowel movements on at least four days within a one week period (7
        days).

        Exclusion Criteria:

          1. Males or females <18 and >70 years of age

          2. Have a IBS symptom severity score < 175 as defined by IBS-SSS

          3. BMI: <18 or >39 kg/m^2

          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. Participant is currently enrolled in or has not yet completed at least 30 days since
             ending other investigational device or drug study(s), or participant is receiving
             other investigational agent(s)

          8. Have a malignant disease or any concomitant end-stage organ disease.

          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 fertile participants
             (females) 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

         11. Use of antibiotics within 1 month of screening

         12. Use of systemic steroids within the last month

         13. Change in dose or introduction of an antipsychotic within the last month

         14. Have suffered from a 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 gastrointestinal-related abdominal surgery other than hernia repair or
             appendectomy

         20. Participants taking prucalopride

         21. Other investigational procedures while participating in this study are excluded

         22. Known HIV infection, or hepatitis A, B, or C active infection

         23. Participants with abnormal laboratory values at screening deemed by the investigator
             to be clinically significant

         24. Participants who have taken commercially available probiotics within the last month
             (30 days prior to randomization)

         25. Participants with known or suspected hereditary fructose intolerance,
             glucose-galactose malabsorption or sucrase-isomaltose insufficiency

         26. Participants taking guanylate cyclase agonists, such as linaclotide and lubiprostone