Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
4D pharma plc
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented history and diagnosis of asthma at least 6 months prior to Visit 1.
Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
ACQ-6 score \>1.5 and \<=4
FEV1 \>50% of predicted normal
Following protocol specified contraception requirements.
You may not be if
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
