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

NCT03721107 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BHT-II-002
• Study Type: interventional
• Target: 366
• Locations: 3 countries
• Sites: 34

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Keywords

constipation; diarrhea

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Response

  Overall responder was a participant who has at least 7 evaluable weeks of data and has reported an improvement in their weekly symptoms (abdominal pain intensity \[API\] and stool frequency \[SF\] or consistency \[SC\]) for greater than or equal to (\>=) 50 percent (%) of the treatment period. Improvement for abdominal pain intensity was defined as decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline for Cohort C and Cohort D, for stool frequency was defined as increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with baseline for Cohort C and for stool consistency was defined as decrease at least 50% in the proportion of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline for Cohort D. Participants with \<4 weeks available were considered non-responders.

  Baseline up to Week 8

Secondary Outcomes (8)

• Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)

  Baseline up to follow-up visit (up to Week 14)

• Number of Participants With Response to Subject Global Assessment of Relief

  Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

• Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)

  Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

• Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)

  Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

• Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)

  Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14)

Study Arms (4)

Cohort C: Blautix

EXPERIMENTAL

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).

Biological: Blautix

Cohort C: Placebo

PLACEBO COMPARATOR

Participants diagnosed with IBS-C received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.

Other: Placebo

Cohort D: Blautix

EXPERIMENTAL

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.

Biological: Blautix

Cohort D Placebo

PLACEBO COMPARATOR

Participants diagnosed with IBS-D received two capsules of placebo matched to Blautix orally, twice daily for 8 weeks.

Other: Placebo

Interventions

Blautix BIOLOGICAL

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.

Also known as: MRx1234, Blautia Hydrogenotrophica

Cohort C: Blautix; Cohort D: Blautix

Placebo OTHER

Placebo control

Cohort C: Placebo; Cohort D Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved informed consent form before any study specific evaluation
• Males and Females between 18 and 70 years of age
• Body Mass Index (BMI): 18-39 kg/m\^2
• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• 4D pharma plc: lead

Study Sites (34)

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Translational Research Group, Inc

North Hollywood, California, 91606, United States

Location

Probe Clinical Research

Riverside, California, 92501, United States

Location

Connecticut Gastroenterology Clinical Research

Bristol, Connecticut, 06010, United States

Location

Digestive CARE of North Broward, LLC

Coral Springs, Florida, 33065, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Orlando Florida BioClinica Research Network

Orlando, Florida, 32806, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

East Coast Institute for Research, LLC.

Saint Augustine, Florida, 32086, United States

Location

Guardian Angel Research Center

Tampa, Florida, 33614, United States

Location

Georgia Medical Associates

Snellville, Georgia, 30078, United States

Location

Evanston Premier Healthcare & Research, LLC.

Evanston, Illinois, 60201, United States

Location

Centex Research, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Capitol Research

Rockville, Maryland, 20850, United States

Location

Specialists in Gastroenterology

St Louis, Missouri, 63141, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

WR-ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

Houston Methodist Gastroenterology Associates

Houston, Texas, 77030, United States

Location

Gulf Coast Medical Research, LLC.

Missouri City, Texas, 77459, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Cork University Hospital

Cork, T12 YE02, Ireland

Location

MAC Clinical Research (Barnsley)

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research (Blackpool)

Blackpool, United Kingdom

Location

MAC Clinical Research (Cannock)

Cannock, WS11 0BN, United Kingdom

Location

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

MAC Clinical Research (Leeds)

Leeds, LS10 1DU, United Kingdom

Location

MAC Clinical Research (Liverpool)

Liverpool, L34 1BH, United Kingdom

Location

MAC Clinical Research (Manchester)

Manchester, M13 9NQ, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

MAC Clinical Research (Stockton-on-Tees)

Stockton-on-Tees, TS17 6EW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36369645 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Programme Development Director
• Organization: 4D pharma plc

clinicaltrials@4dpharmaplc.com

+4401138950130

Study Officials

• Eamonn Quigley

  Houston Methodist Gastroenterology Clinical Research Foundation, Houston, Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind trial design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 26, 2018
• Study Start: October 11, 2018
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); GB (9); IE (1)