A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome
NCT ID: NCT03721107
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
366 participants
INTERVENTIONAL
2018-10-11
2020-05-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort C: Blautix
Participants diagnosed with Irritable bowel syndrome subtype C (IBS-C) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) will be 10\^10 to10\^11 most probable number (MPN).
Blautix
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.
Cohort C: Placebo
Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Placebo
Placebo control
Cohort D: Blautix
Participants diagnosed with Irritable bowel syndrome subtype D (IBS-D) received two capsules of Blautix orally, twice daily for 8 weeks. Maximum daily dose of Blautix (strain of Blautia hydrogenotrophica) will be 10\^10 to10\^11 MPN.
Blautix
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.
Cohort D Placebo
Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.
Placebo
Placebo control
Interventions
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Blautix
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
Placebo control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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4D pharma plc
INDUSTRY
Responsible Party
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Principal Investigators
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Eamonn Quigley
Role: PRINCIPAL_INVESTIGATOR
Houston Methodist Gastroenterology Clinical Research Foundation, Houston, Texas
Locations
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Clinical Research Associates
Huntsville, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Translational Research Group, Inc
North Hollywood, California, United States
Probe Clinical Research
Riverside, California, United States
Connecticut Gastroenterology Clinical Research
Bristol, Connecticut, United States
Digestive CARE of North Broward, LLC
Coral Springs, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Orlando Florida BioClinica Research Network
Orlando, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
East Coast Institute for Research, LLC.
Saint Augustine, Florida, United States
Guardian Angel Research Center
Tampa, Florida, United States
Georgia Medical Associates
Snellville, Georgia, United States
Evanston Premier Healthcare & Research, LLC.
Evanston, Illinois, United States
Centex Research, Inc.
Lake Charles, Louisiana, United States
Capitol Research
Rockville, Maryland, United States
Specialists in Gastroenterology
St Louis, Missouri, United States
PharmQuest
Greensboro, North Carolina, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
WR-ClinSearch
Chattanooga, Tennessee, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Houston Methodist Gastroenterology Associates
Houston, Texas, United States
Gulf Coast Medical Research, LLC.
Missouri City, Texas, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Cork University Hospital
Cork, , Ireland
MAC Clinical Research (Barnsley)
Barnsley, , United Kingdom
MAC Clinical Research (Blackpool)
Blackpool, , United Kingdom
MAC Clinical Research (Cannock)
Cannock, , United Kingdom
CPS Research
Glasgow, , United Kingdom
MAC Clinical Research (Leeds)
Leeds, , United Kingdom
MAC Clinical Research (Liverpool)
Liverpool, , United Kingdom
MAC Clinical Research (Manchester)
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
MAC Clinical Research (Stockton-on-Tees)
Stockton-on-Tees, , United Kingdom
Countries
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References
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Quigley EMM, Markinson L, Stevenson A, Treasure FP, Lacy BE. Randomised clinical trial: efficacy and safety of the live biotherapeutic product MRx1234 in patients with irritable bowel syndrome. Aliment Pharmacol Ther. 2023 Jan;57(1):81-93. doi: 10.1111/apt.17310. Epub 2022 Nov 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHT-II-002
Identifier Type: -
Identifier Source: org_study_id
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