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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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

Key facts

Study ID: NCT03721107
Run by: 4D pharma plc
People needed: 366
Starts: 2018-10-11
Expected to finish: 2020-05-13
Last updated by the study team: 2022-01-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

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

Full record on ClinicalTrials.gov

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