Probiotic Approach to Combat multi-resistent Enterocci: a cross-over clinical trial on the effect of probiotics on nosocomial spread of CC17 Enterococcus faecium

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN58761709

Enrollment

640

Registered

2007-05-30

Start date

2007-05-01

Completion date

Unknown

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ampicillin-resistant Enterococcus faecium (ARE) infection Infections and Infestations Bacterial infection of unspecified site

Interventions

The name of the probiotic product that is used in this trial is Ecologic® AAD, a multi-species probiotic powder, containing ten species (Bifidobacterium bifidum, Bifidobacterium lactis (2x), Enterococ

Eligibility

Inclusion criteria

Inclusion criteria: All admissions on two wards (gastroenterology/nephrology and geriatrics) of the University Medical Centre Utrecht, where ARE colonisation is endemic.

Exclusion criteria

Exclusion criteria: Does not comply with the above inclusion criteria

Design outcomes

Primary

Measure	Time frame
The difference in acquisition rate of rectal ARE-colonisation between periods A and B. Acquisition of ARE-colonisation is defined as a patient that is not colonised on admission that acquires colonisation during admission. This is measured by a perianal swab within 48 hours after admission and within 72 hours before discharge. At the end of the study, the total acquisition rate of period A is compared with the total acquisition rate of period B to investigate if there is a difference. This analysis is performed for both separate wards.	—

Measure

Time frame

The difference in acquisition rate of rectal ARE-colonisation between periods A and B. Acquisition of ARE-colonisation is defined as a patient that is not colonised on admission that acquires colonisation during admission. This is measured by a perianal swab within 48 hours after admission and within 72 hours before discharge. At the end of the study, the total acquisition rate of period A is compared with the total acquisition rate of period B to investigate if there is a difference. This analysis is performed for both separate wards.

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Secondary

Measure	Time frame
The difference in prevalence of rectal ARE-colonisation between periods A and B. Twice weekly all patients are screened for ARE-colonisation. On these days the prevalence of ARE-colonisation can be determined. Because of natural fluctuations, these prevalences will differ per day. Therefore, at the end of the study the mean prevalence and the distribution of ARE-colonisation in period A will be compared with period B to investigate if there is a difference that can be explained by the use of the investigational product. This analysis is performed for both separate wards.	—

Measure

Time frame

The difference in prevalence of rectal ARE-colonisation between periods A and B. Twice weekly all patients are screened for ARE-colonisation. On these days the prevalence of ARE-colonisation can be determined. Because of natural fluctuations, these prevalences will differ per day. Therefore, at the end of the study the mean prevalence and the distribution of ARE-colonisation in period A will be compared with period B to investigate if there is a difference that can be explained by the use of the investigational product. This analysis is performed for both separate wards.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026