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

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ClinicalTrials.gov Identifier: NCT03721107
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
4D pharma plc

Brief Summary:
A study to evaluate the effectiveness of oral doses of Blautix in adult subjects with irritable bowel syndrome (IBS)

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Biological: MRx1234 [Blautia Hydrogenotrophica] Other: Placebo Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind trial design
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of Blautix in Adult Subjects With Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Cohort C Active
two capsules Blautix administered twice daily to subjects diagnosed with IBS-C
Biological: MRx1234 [Blautia Hydrogenotrophica]
MRx1234 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is two capsules two times per day for the duration of the treatment period.

Placebo Comparator: Cohort C Placebo
two capsules placebo administered twice daily to subjects diagnosed with IBS-C
Other: Placebo
Placebo control

Experimental: Cohort D Active
two capsules Blautix administered twice daily to subjects diagnosed with IBS-D
Biological: MRx1234 [Blautia Hydrogenotrophica]
MRx1234 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is two capsules two times per day for the duration of the treatment period.

Placebo Comparator: Cohort D Placebo
two capsules placebo administered twice daily to subjects diagnosed with IBS-D
Other: Placebo
Placebo control




Primary Outcome Measures :
  1. The number of patients who demonstrate more or equal to 50% improvement in their cohort specific symptoms as measured by responses to Abdominal Pain Intensity Scale, Stool Frequency and Stool Consistency questionnaires [ Time Frame: Baseline to EOT up to a maximum of 8 weeks, two treatment cycles (one cycle = 28 days) ]
    Patients will be assessed as overall responders, if they have reported an improvement in their weekly (cohort specific) symptoms for > or equal to 50% of the treatment period. The abdominal pain intensity scale is measured on an11-point Numeric Rating Scale ranging from 0 (none) to 10 (worst possible pain)


Secondary Outcome Measures :
  1. The number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Baseline to EOT up to a maximum of 8 weeks, two treatment cycles (one cycle = 28 days) ]
    To review incidence, nature, severity, relatedness, expectedness and outcome of adverse events. Haematology and blood chemistry assessments and vital signs


Other Outcome Measures:
  1. Review how the study drug affects and interacts with the body [ Time Frame: Baseline to Follow Up visit up to a maximum of 16 weeks, two treatment cycles (one cycle = 28 days) ]
    To look at the faecal microbiota profiles and urine and faecal metabolite profiles to see if either show any correlation to the amelioration of IBS-symptoms during treatment with Blautix

  2. How effective is daily doses of Blautix by review of completed QoL and PRO questionnaires [ Time Frame: Baseline to Follow Up visit up to a maximum of 16 weeks, two treatment cycles (one cycle = 28 days) ]
    review of completed responses to Subject Global Assessment of relief compared from Baseline to FUp as measured on a 5-point Likert scale with the following options Completely relieved, considerably relieved, somewhat relieved; unchanged; worse. Patients will be specifying their level of agreement or disagreement on a symmetric agree-disagree scale for a series of questions

  3. How effective is daily doses of Blautix by review of completed QoL and PRO questionnaires [ Time Frame: Baseline to Follow Up visit up to a maximum of 16 weeks, two treatment cycles (one cycle = 28 days) ]
    Review of responses to the Stool Consistency and frequency measured on the Bristol Stool Chart for stool types

  4. How effective is daily doses of Blautix by review of completed QoL and PRO questionnaires [ Time Frame: Baseline to Follow Up visit up to a maximum of 16 weeks, two treatment cycles (one cycle = 28 days) ]
    review of responses to the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from Baseline to FUp. The IBS-SSS is measured on a Visual Analog Scale (VAS scale) in combination with reported numeric values which equates to an overall score. Q1-4 are severity scoring and Q5-7clinical assessment. Reponses are totalled for Q1-4 (pts indicate on the vas scale from 0-100 ow much they agree with the statements asked o produce an overall score which is then used to categorize patients as no symptoms, mild, moderate or severe. The category thresholds are as follows '0 = no symptoms, 75-175 = mild symptoms, 176-300 moderate symptoms and more than 300 is severe symptoms

  5. How effective is daily doses of Blautix by review of completed QoL and PRO questionnaires [ Time Frame: Baseline to Follow Up visit up to a maximum of 16 weeks, two treatment cycles (one cycle = 28 days) ]
    review of responses to the Irritable Bowel Symptom Quality of Life (IBS-QOL) questionnaire from baseline to FUp. This is measured across 34 questions with a 5 point response. Each of the 34 questions will contain 5 possible responses 1:not at all, 2: slightly 3:moderately, 4:quite a bit & 5:extremely. Depending on the response to each of these five question , theses are calculated togather for an overall score. Depending on the question the scale of questions

  6. How effective is daily doses of Blautix by review of completed QoL and PRO questionnaires [ Time Frame: Baseline to Follow Up visit up to a maximum of 16 weeks, two treatment cycles (one cycle = 28 days) ]
    review of responses to the Health Anxiety and Depression Scale from baseline to FUP. Each item is scored from 0-3. A subject can score 0 to 21 for either anxiety or depression depression"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721107


Contacts
Contact: Clinical Operations +4401138950130 clinicaltrials@4dpharmaplc.com

Locations
United States, Arizona
Elite Clinical Studies Recruiting
Phoenix, Arizona, United States, 85018
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, California
Anaheim Clinical Trials (ACT) Withdrawn
Anaheim, California, United States, 92801
Translational Research Group, Inc Recruiting
North Hollywood, California, United States, 91606
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, Connecticut
Connecticut Gastroenterology Clinical Research Recruiting
Bristol, Connecticut, United States, 06010
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
Orlando Florida BioClinica Research Network Not yet recruiting
Orlando, Florida, United States, 32806
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, Ohio
Aventiv Research Inc. Recruiting
Columbus, Ohio, United States, 43213
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, South Carolina
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, Tennessee
WR-ClinSearch Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United States, Texas
Houston Methodist Gastroenterology Associates Not yet recruiting
Houston, Texas, United States, 77030
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
Ireland
Cork University Hospital Not yet recruiting
Cork, Ireland, T12 YE02
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
United Kingdom
Wythenshawe Hospital Not yet recruiting
Manchester, United Kingdom, M23 9LT
Contact: Clinical Operations       clinicaltrials@4dpharmaplc.com   
Sponsors and Collaborators
4D pharma plc
Investigators
Principal Investigator: Eamonn Quigley Houston Methodist Gastroenterology Clinical Research Foundation, Houston, Texas

Responsible Party: 4D pharma plc
ClinicalTrials.gov Identifier: NCT03721107     History of Changes
Other Study ID Numbers: BHT-II-002
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by 4D pharma plc:
constipation
diarrhea

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases