A Study of MRx-4DP0004 in Asthma

Exclusion Criteria

• •Non-compliant with prescribed asthma maintenance treatment.
• •At significant risk of exposure to a change in environmental sensitising substances during the study.
• •Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.
• •Hepatitis B or C or HIV.
• •GI fistula, feeding tubes or inflammatory bowel disease.
• •GI disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease.
• •History of life-threatening asthma.
• •Systemic corticosteroids within 6 weeks of first dose.
• •Allergy to all of ampicillin, clindamycin and imipenem.
• •Probiotic supplements.
• •Immunosuppression or immunosuppressant medication.
• •Use of ICS and LABA as Maintenance and Reliever Therapy.
• •Smokers or nicotine users within 3 months of screening.
• •Former smokers \>15 pack years.
• •Systemic antibiotics within 6 weeks of first dose.
• •Clinically significant haematology and serum biochemistry.
• •Sensitivity to any constituent of IMP.
• •Diastolic blood pressure \<45 or \>90, systolic blood pressure \<95 or \>155mmHg, Pulse rate \<40 or \>100 bpm.
• •Clinically significant ECGs or structural cardiac abnormalities.
• •Any other condition that may interfere with primary objective.
• •Receipt of a positive COVID-19 test result within 4 weeks of first dose of IMP