CompletedPhase 2

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

United States366 participantsStarted 2018-10-11

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Have a moderate or severe IBS symptom severity score (\> 175) as defined by IBS-SSS

✕. 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.

Percentage of Participants With Overall Response

Timeframe: Baseline up to Week 8

NCT IDNCT03721107

Sponsor4D pharma plc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-13

Results submitted2021-09-06

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Have a moderate or severe IBS symptom severity score (\> 175) as defined by IBS-SSS

✕. 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.