Can Lactobacillus plantarum 299v in fermented oat meal gruel prevent overgrowth of Clostridium difficile in the Gastrointestinal (GI) tract in antibiotic treated critically ill patients? [Kan Lactobacillus Plantarum 299v i fermenterad havrevälling motverka överväxt av Clostridium Difficile i magtarmkanalen hos antibiotikabehandlade kritiskt sjuka patienter?]

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85655545

Enrollment

100

Registered

2007-09-17

Start date

2001-12-01

Completion date

Unknown

Last updated

2021-09-13

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

Conditions

Overgrowth of C. difficile in GI tract of antibiotic-treated ICU patients Infections and Infestations Intestinal infection

Interventions

1. Active group receives a fermented oatmeal formula containing 8 x 10^8 colony forming units (cfu)/ml of Lactobacillus plantarum 299v 2. Control product contains no bacteria. Lactic a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Critically ill, defined by a presumed need of intensive care for three days or more 3. Not have any known positive test for C. difficile within the week before enrolment 4. Be anticipated to tolerate enteral feeding 5. Starting within 24 hours from ICU admission

Exclusion criteria

Exclusion criteria: 1. Not be allergic to any of the components in the study product 2. If entereral feeding (including study product) is not started within 24 hours 3. Not be moribund

Design outcomes

Primary

Measure	Time frame
To study the impact of L plantarum 299v on emerging cases of C. difficile in ICU patients compared to those receiving a placebo product. The primary outcome is validated over the whole period in the Intensive Care Unit and cultures from faeces are taken twice a week. Overgrowth or colonisation with C difficile can appear in the range from a few days to several weeks of antibiotic treatment and even after the medication has ended.	—

Measure

Time frame

To study the impact of L plantarum 299v on emerging cases of C. difficile in ICU patients compared to those receiving a placebo product. The primary outcome is validated over the whole period in the Intensive Care Unit and cultures from faeces are taken twice a week. Overgrowth or colonisation with C difficile can appear in the range from a few days to several weeks of antibiotic treatment and even after the medication has ended.

—

Secondary

Measure	Time frame
1. Study gut barrier function 2. Recovery rates of L plantarum 299v, and other effects on the gut microbiota 3. Systemic infections 4. Immune response, as White Blood Cell count (WBC), C-Reactive Protein (CRP) and cytokines (Tumour Necrotising Factor [TNF], Interleukin-1 [IL-1], Interleukin-6 [IL-6] and Interleukin-10 [IL-10]) 5. Influence on metabolic parameters Gut permeability is tested at inclusion day (day 1) and on day 4 so outcome is measured on study day 4. Faecal samples are taken at enrolment and then twice a week. Recovery of added bacteria are validated for the whole Length of Stay (LOS). Due to impaired function of the bowel in critically ill patients passage time through the gut varies so much that the whole LOS will be used to evaluate colonisation with L plantarum 299v. Microbiological cultures (as tests for systemic infections) are taken on clinical grounds or at least once a week and results are summarised for the whole LOS. Infectious, inflammatory and metabolic parameters are followed by daily blood tests throughout the stay in the ICU. Daily comparisons will be performed for the active treatment and placebo groups.	—

Measure

Time frame

1. Study gut barrier function 2. Recovery rates of L plantarum 299v, and other effects on the gut microbiota 3. Systemic infections 4. Immune response, as White Blood Cell count (WBC), C-Reactive Protein (CRP) and cytokines (Tumour Necrotising Factor [TNF], Interleukin-1 [IL-1], Interleukin-6 [IL-6] and Interleukin-10 [IL-10]) 5. Influence on metabolic parameters Gut permeability is tested at inclusion day (day 1) and on day 4 so outcome is measured on study day 4. Faecal samples are taken at enrolment and then twice a week. Recovery of added bacteria are validated for the whole Length of Stay (LOS). Due to impaired function of the bowel in critically ill patients passage time through the gut varies so much that the whole LOS will be used to evaluate colonisation with L plantarum 299v. Microbiological cultures (as tests for systemic infections) are taken on clinical grounds or at least once a week and results are summarised for the whole LOS. Infectious, inflammatory and metabolic parameters are followed by daily blood tests throughout the stay in the ICU. Daily comparisons will be performed for the active treatment and placebo groups.

—

Countries

Sweden

Outcome results

None listed

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