A Trial for New Treatment of Adult Patients With Irritable Bowel Syndrome

500 subjects will be enrolled with a diagnosis of IBS as defined by Rome IV criteria will be
classified into cohorts according to the Rome IV classification of IBS subtypes.

Each cohort (Cohort C & Cohort D) will recruit 250 subjects who will randomly receive either
Blautix or matching placebo in a 1:1 ratio overall of treated to control subjects.

Subjects will undergo five visits in total across approximately 13 weeks. During the study
treatment phase subjects will be asked to complete a variety of Quality of Life
questionnaires at certain time points. These will consist of Abdominal Pain Intensity Score,
IBS-SSS, IBS-QoL, HADS, Stool frequency, Stool consistency & FFQ.

Subjects will be required to produce relevant blood, urine and faecal samples at
pre-determined timepoints from screening through to End of Treatment & follow up visits.

Inclusion Criteria:

1. Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee
(I 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 as
defined per Table 2

5. Have a moderate or severe IBS symptom severity score (> 175) as defined by IBS-SSS *
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

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. Subject must have fewer than 3
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. Subjects 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/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 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 patients
(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 abdominal surgery other than hernia repair or appendectomy

20. Other investigational procedures while participating in this study are excluded

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-isomaltose insufficiency