Do food supplements containing live bacteria (probiotics) reduce or stop a particular infection (CPE) living in the bowel?

Not Applicable

• Conditions: Patients with colonised carbapenemase-bearing Klebsiella pneumoniae; Infections and Infestations

• Registration Number: ISRCTN11133689
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-30
• Last Update Posted: 16 September 2019
• Study Completion: 2019-12-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Written informed consent
2. Male or female; aged 18 years or older
3. Immunocompetent as per medical history
4. TCD-KP detected on rectal screening in the last 2 months
5. Not currently hospital inpatient (when planning starting probiotic supplementation)

All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise.

Exclusion Criteria

1. Any active infection at the time of enrolment
2. Presence of or likely to develop mucositis on examination, as per medical history
3. History of Presence cardiac prostheses
4. Consumption of any marketed probiotic product in the 30 day period prior to enrolment and during the duration of the trial
5. Consumption of Over the Counter (OTC) medication or herbal remedies labelled as to improve your immunity system or for daily immunity”
6. In receipt of systemic or intestinal antibiotic within 14 days before baseline samples to be taken
7. Receiving or intended to receive antibiotic within 30 days of 1st baseline sample
8. Current and past history of pancreatitis
9. Concurrent melaena
10. Abdominal surgery within the 3 months prior to study enrolment
11. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy
12. Any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
13. Past medical history of Severe renal dysfunction at Visit 0, defined as e GFR <30 mL/min, or end-stage renal disease requiring dialysis.
14. History of severe hepatic impairment or liver dysfunction at Visit 0, defined as total bilirubin above the ULN (excluding patients with Gilbert’s syndrome), AST or ALT >3 times the ULN or alkaline phosphatase >2.5 times the ULN
15. Known hypersensitivity to any of the components of the probiotic.
16. Pregnancy, lactation or planning pregnancy. A pregnancy test will not be required before study enrolment, however, if a woman determines that she is pregnant during the study period, she must stop the probiotic

Study & Design

• Study Type: Interventional
• Study Design: Not specified