A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome
Status and phase
Conditions
Treatments
Details and patient eligibility
About
A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).
Full description
Participants with a diagnosis of IBS will be enrolled as defined by Rome IV criteria and will be classified into cohorts according to the Rome IV classification of IBS subtypes.
Each cohort (Cohort C and Cohort D) will recruit participants who will randomly receive either Blautix or matching placebo in a 1:1 ratio overall of treated to control participants.
Participants will undergo five visits in total across approximately 13 weeks. During the study treatment phase, participants 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 symptom severity (IBS-SSS), IBS quality of life (IBS-QoL), hospital anxiety and depression score (HADS), stool frequency, stool consistency & food frequency questionnaire.
Participants will be required to produce relevant blood, urine and faecal samples at pre-determined timepoints from screening through to End of Treatment and follow up visits.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved informed consent form before any study specific evaluation
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Males and Females between 18 and 70 years of age
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Body Mass Index (BMI): 18-39 kg/m^2
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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
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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
- Males or females <18 and >70 years of age
- Have a IBS symptom severity score < 175 as defined by IBS-SSS
- BMI: <18 or >39 kg/m^2
- 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)
- Confirmed clinical diagnosis of bile acid malabsorption and / or on medication for bile acid malabsorption
- 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
- 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)
- Have a malignant disease or any concomitant end-stage organ disease.
- Females who are pregnant or breast feeding
- 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
- Use of antibiotics within 1 month of screening
- Use of systemic steroids within the last month
- Change in dose or introduction of an antipsychotic within the last month
- Have suffered from a major psychiatric disorder
- Clinically diagnosed Lactose intolerance
- Clinically diagnosed Coeliac disease
- Change of diet e.g. FODMAP, gluten-free within last 3 months
- 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.
- Any gastrointestinal-related abdominal surgery other than hernia repair or appendectomy
- Participants taking prucalopride
- Other investigational procedures while participating in this study are excluded
- Known HIV infection, or hepatitis A, B, or C active infection
- Participants with abnormal laboratory values at screening deemed by the investigator to be clinically significant
- Participants who have taken commercially available probiotics within the last month (30 days prior to randomization)
- Participants with known or suspected hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltose insufficiency
- Participants taking guanylate cyclase agonists, such as linaclotide and lubiprostone
Trial design
Primary purpose
Allocation
Interventional model
Masking
366 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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