Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03851250
Eligibility Criteria:
Inclusion Criteria:
* 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.
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03851250
Study Brief:
Protocol Section:
NCT03851250