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

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Blautix

Placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring constipation, diarrhea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Cohort C: Blautix

Cohort C: Placebo

Cohort D: Blautix

Cohort D Placebo

Arm Description

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).

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

An adverse event (AE) was any untoward medical occurrence in a participant administered study medication and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened in severity on or after the start date of the study treatment and includes all AEs recorded through the follow-up visit. A treatment-related TEAE was a TEAE possibly related to the study treatment.

Number of Participants With Response to Subject Global Assessment of Relief

The subject global assessment of relief was collected weekly through the electronic clinical outcome assessment (eCOA) system. It was a comparison of how the participant has felt over the past week with regards to their IBS to the way they felt before entering the study. It was measured on a 5-point Likert scale with the following responses: Completely relieved; considerably relieved; somewhat relieved; unchanged; worse. The total score ranged from 0-20, where higher scores indicated worsening of condition.

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)

Stool consistency of each bowel movement was rated on 7-level Bristol Stool Chart where Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score range of 1 to 7 where, 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Change in percentage of days per week with at least 1 stool with a undesired stool consistency of 1 or 2 for Cohort C and 6 or 7 for Cohort D on the Bristol Stool Chart from baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14) was reported.

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)

Stool consistency of each bowel movement was assessed by participants using the 7-point BSFS from 1 to 7 where Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Lower numbers represented more formed stools and higher numbers represented less formed stools. A negative change from Baseline indicates improvement.

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)

Stool frequency was defined as a sum of weekly CSBMs. Participants were reminded to rate all their bowel movements in the Bristol Stool Chart (BSC) before answering the question. Stool types were assessed using the 7-point BSFS where 1 = separate hard lumps, like nuts (hard to pass), 2 = sausage-shaped but lumpy, 3 = like a sausage but with cracks on the surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges (passed easily), 6 = fluffy pieces with ragged edges, a mushy stool, 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea. Weekly stool frequency was based on the daily stool frequency which was calculated as follows: if there was 1 or more entry for BSC, the number of BSC entries was summed up. If on that day laxative was used, the daily stool frequency was set to 0. If an answer to CSBMs, but no BSC entry was provided, the daily stool frequency was set to 0 on that day.

Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14)

Participants were asked to complete a QOL of 34 items which formed 8 scales: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items), food avoidance (3 items), social reaction (4 items), sexual (2 items), and relationships (3 items). All 8 scales were rated on a five-point response scale where, 1= not at all, 2= slightly, 3= moderately, 4= quite a bit, 5= extremely or a great deal. Scores for individual items were averaged to obtain a total score for each sub-scale of IBSQoL. Total and subscale scores were transformed to a 0 to 100 point scale (0=lowest score, 100=highest possible score) with higher scores indicating better IBS-specific quality of life. Transformed scale score = (Sum of the items-lowest possible score/Possible raw score range)∗100. A positive change from baseline indicates improved quality of life.

Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14)

Participants were asked to complete a questionnaire on the severity of abdominal distension and pain, frequency of abdominal pain, dissatisfaction with bowel habits, and interference of IBS symptoms with daily life. The IBS-SSS was measured on a Visual Analog Scale (VAS scale) in combination with reported numeric values which equated to an overall score. The scale range was from 0 (no symptoms) to 500 (maximum severity). Participants were categorized as having mild (74-174), moderate (175-299), or severe (>300) IBS symptoms based on symptomology. Higher scores were indicative of greater disease severity (worse outcome). A negative change from Baseline indicates improvement.

Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14)

Participants were asked to complete the HADS which was a 14-item scale (7 items- anxiety and 7 items-depression) that generated ordinal data. Each question was rated on a scale from 0 - 3. The outcome of the HADS questionnaire was two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression. A negative change from Baseline indicates improvement.

Full Information

NCT ID

NCT03721107

First Posted

October 1, 2018

Last Updated

December 22, 2021

Sponsor

4D pharma plc

1. Study Identification

Unique Protocol Identification Number

NCT03721107

Brief Title

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

Official Title

A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicenter 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 11, 2018 (Actual)

Primary Completion Date

May 13, 2020 (Actual)

Study Completion Date

May 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

4D pharma plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

constipation, diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double blind trial design

Allocation

Randomized

Enrollment

366 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort C: Blautix

Arm Type

Experimental

Arm Description

Arm Title

Cohort C: Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Cohort D: Blautix

Arm Type

Experimental

Arm Description

Arm Title

Cohort D Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Blautix

Other Intervention Name(s)

MRx1234, Blautia Hydrogenotrophica

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo control

Primary Outcome Measure Information:

Title

Percentage of Participants With Overall Response

Description

Time Frame

Baseline up to Week 8

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Number of Participants With Response to Subject Global Assessment of Relief

Description

Time Frame

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

Title

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)

Description

Time Frame

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

Title

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)

Description

Time Frame

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

Title

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)

Description

Time Frame

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

Title

Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14)

Description

Time Frame

Baseline, Week 4, 8, follow-up visit (Weeks 12-14)

Title

Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14)

Description

Time Frame

Baseline, Week 4, 8, follow-up visit (Weeks 12-14)

Title

Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14)

Description

Time Frame

Baseline, Week 4, 8, follow-up visit (Weeks 12-14)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eamonn Quigley

Organizational Affiliation

Houston Methodist Gastroenterology Clinical Research Foundation, Houston, Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Associates

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Elite Clinical Studies

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Translational Research Group, Inc

City

North Hollywood

State/Province

California

ZIP/Postal Code

91606

Country

United States

Facility Name

Probe Clinical Research

City

Riverside

State/Province

California

ZIP/Postal Code

92501

Country

United States

Facility Name

Connecticut Gastroenterology Clinical Research

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Digestive CARE of North Broward, LLC

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33065

Country

United States

Facility Name

Borland-Groover Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Orlando Florida BioClinica Research Network

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Clinical Research Center of Florida

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33060

Country

United States

Facility Name

East Coast Institute for Research, LLC.

City

Saint Augustine

State/Province

Florida

ZIP/Postal Code

32086

Country

United States

Facility Name

Guardian Angel Research Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Georgia Medical Associates

City

Snellville

State/Province

Georgia

ZIP/Postal Code

30078

Country

United States

Facility Name

Evanston Premier Healthcare & Research, LLC.

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Centex Research, Inc.

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Capitol Research

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Specialists in Gastroenterology

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

PharmQuest

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Aventiv Research Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Coastal Carolina Research Center

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

WR-ClinSearch

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Clinical Neuroscience Solutions, Inc

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Houston Methodist Gastroenterology Associates

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Gulf Coast Medical Research, LLC.

City

Missouri City

State/Province

Texas

ZIP/Postal Code

77459

Country

United States

Facility Name

Blue Ridge Medical Research

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24502

Country

United States

Facility Name

Cork University Hospital

City

Cork

ZIP/Postal Code

T12 YE02

Country

Ireland

Facility Name

MAC Clinical Research (Barnsley)

City

Barnsley

ZIP/Postal Code

S75 3DL

Country

United Kingdom

Facility Name

MAC Clinical Research (Blackpool)

City

Blackpool

Country

United Kingdom

Facility Name

MAC Clinical Research (Cannock)

City

Cannock

ZIP/Postal Code

WS11 0BN

Country

United Kingdom

Facility Name

CPS Research

City

Glasgow

ZIP/Postal Code

G20 0XA

Country

United Kingdom

Facility Name

MAC Clinical Research (Leeds)

City

Leeds

ZIP/Postal Code

LS10 1DU

Country

United Kingdom

Facility Name

MAC Clinical Research (Liverpool)

City

Liverpool

ZIP/Postal Code

L34 1BH

Country

United Kingdom

Facility Name

MAC Clinical Research (Manchester)

City

Manchester

ZIP/Postal Code

M13 9NQ

Country

United Kingdom

Facility Name

Wythenshawe Hospital

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

MAC Clinical Research (Stockton-on-Tees)

City

Stockton-on-Tees

ZIP/Postal Code

TS17 6EW

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36369645

Citation

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.

Results Reference

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Learn more about this trial

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

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

Irritable Bowel Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial