Oral Blautix™ in adults subjects with IBS subtypes IBS-C and IBS-D
Research type
Research Study
Full title
A PHASE 2 RANDOMISED, 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
IRAS ID
246158
Contact name
Peter Whorwell
Contact email
Sponsor organisation
4D Pharma Plc
Eudract number
2018-001203-36
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Irritable bowel syndrome (IBS) is a chronic, debilitating, gastrointestinal functional disorder). IBS is characterised by abdominal pain or discomfort in association with alteration in either stool form or frequency. IBS patients can be classified as either diarrhoea predominant (IBS-D), constipation predominant (IBS-C), or with a mixed bowel pattern (IBS- M). Furthermore, IBS is associated with several comorbidities, including somatic pain syndromes (fibromyalgia, chronic fatigue, and chronic pelvic pain), gastrointestinal disorders (gastroesophageal reflux and dyspepsia) and psychiatric disorders (i.e., depression, anxiety, and somatisation). The causes of IBS are not clear. Theories include combinations of gut–brain axis problems, gut motility disorders, pain sensitivity, infections including small intestinal bacterial overgrowth, neurotransmitters, genetic factors, and food sensitivity. Onset may be triggered by an intestinal infection, or stressful life event. IBS is a functional gastrointestinal disorder. Studies have demonstrated that treatment with live bacteria may have beneficial effects on IBS
symptoms by restoring homeostasis in the gut microbiota, normalisation of cytokine blood levels, normalising intestinal transit time, decreasing small intestine permeability, and eliminating small intestinal overgrowth of fermenting bacteria. This emerging field of research demonstrates the feasibility of therapeutic manipulation of the microbiome using live bacteria to improve symptom of IBS. Blautix™ is a live biotherapeutic product (LBP) under development by 4D Pharma for the treatment of Irritable Bowel Syndrome. This study will be conducted to assess the efficacy and safety of Blautix™ in adults with IBS, assigned to either IBS-C or IBS-D clinical subtypes. We will be looking at the response to treatment where a patient will be categorised as an overall responder if they have reported an improvement in their weekly (subtype specific) symptoms for 4 out of 8 weeks. Safety will be assessed through collection and analysis of adverse event data and clinical laboratory values. Exploratory endpoints will include the ability of Blautix™ to restore a health-associated microbiota composition, including diversity and stability at study timepoints compared to baseline and if/how this correlates with amelioration of symptoms in IBS patients.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0565
Date of REC Opinion
29 Oct 2018
REC opinion
Further Information Favourable Opinion