Can restoring the balance of healthy bowel bacteria help to fight antibiotic resistance?
- Conditions
- Antimicrobial resistance (carbapenem resistant Enetrobacteriales and/or extended spectrum beta-lactamase producing Enterobacteriales)Infections and Infestations
- Registration Number
- ISRCTN34467677
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32457083/ protocol (added 28/05/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 44
Current participant inclusion criteria as of 20/07/2020:
1. Adult patients (age 18 years or older at time of consent)
2. Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust
3. Ability to understand the purpose, potential benefits, and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent.
4. Documented gastrointestinal carriage of ESBL or CPE (stool sample) in the 21 days prior to consent.
5. Symptomatic infection with the same target organism of interest in the preceding 6 months
Previous participant inclusion criteria:
1. Adult patients (age >18 years at time of randomisation)
2. Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust
3. Ability to understand the purpose, potential benefits and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent
4. Documented gastrointestinal carriage of ESBL or CPE (rectal swab or stool sample) within 21 days of randomisation
5. Symptomatic infection with the same target organism of interest in the preceding 6 months
Current participant exclusion criteria as of 20/07/2020:
1. Pregnancy or planned pregnancy. Urine testing will be performed at screening to rule out pregnancy
2. Breastfeeding
3. Severe or life-threatening food allergy
4. Allergy or other contraindication to omeprazole, IMP or placebo ingredients
5. Treatment with systemic antibiotic on the day prior to 1st IMP/placebo dosing to the end of the dosing period
6. Treatment with pre or probiotics in the 4 weeks prior to randomisation and for the duration of the study
7. Severe immunodeficiency
7.1. Systemic chemotherapy <30 days from baseline or planned chemotherapy within the upcoming 6 months
7.2. Known HIV infection with CD4 count <250 cells/uL
7.3. Known neutropenia with absolute neutrophils <1.0x109
7.4. Prolonged treatment with corticosteroids (equivalent to prednisone >60 mg daily for > 30 days) within 8 weeks of randomisation
8. Life expectancy <6 months
9. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication
10. Patients who have received another investigational drug or device within 4 months prior to randomisation
Previous participant exclusion criteria:
1. Pregnancy or planned pregnancy. Urine testing will be performed at screening to rule out pregnancy in females
2. Breastfeeding
3. Severe or life-threatening food allergy
4. Allergy or other contraindication to any of the study drugs (omeprazole 20 mg)
5. Treatment with systemic antibiotic on the day prior to 1st IMP/placebo dosing to the end of the dosing period
6. Treatment with pre or probiotics in the 4 weeks prior to randomisation and for the duration of the study
7. Severe immunodeficiency;
7.1. Systemic chemotherapy <30 days from baseline or planned chemotherapy within the upcoming 6 months
7.2. Known HIV infection with CD4 count <250 cells/uL
7.3. Known neutropenia with absolute neutrophils <1.0x109
7.4. Prolonged treatment with corticosteroids (equivalent to prednisone >60 mg daily for > 30 days) within 8 weeks of randomisation
8. Life expectancy <6 months
9. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication
10. Patients who have received another investigational drug or device within 30 days prior to randomisation
11. Any condition or circumstance, in the opinion of the investigator, that would compromise the safety of the patient or the quality of the study data
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method