Nosocomial Infection Clinical Trial
— EPISODEOfficial title:
Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children
Verified date | April 2021 |
Source | Larena SAS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in young / very young children. These infections tend to prolong the average length of hospital stay of this fragile population. Conventional treatment of these infections, in the absence of knowledge of the infectious agent, is purely symptomatic. It is therefore necessary to develop new prevention strategies for this type of disease. In this sense, the administration of probiotic strains in order to prevent the onset of nosocomial diarrhea is a promising avenue and the present study aims to validate the preventive effect of this supplement. The objective of this study is to assess the effect of Babybiane® Imedia or the microbiotic strain Lactobacillus rhamnosus GG LA801 in the preventive nutritional management of nosocomial diarrhea in children aged 1 to 24 months. This evaluation will be made in comparison with a placebo. The tolerance of the product under study will also be assessed.
Status | Terminated |
Enrollment | 61 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 24 Months |
Eligibility | Inclusion Criteria: - Informed consent signed by the patient's legal guardian(s) for study enrollment; - Aged 1 to 24 months ; - Admitted to the hospital for reasons other than diarrhea; - Stayed in the Short Stay Unit, SSU, for a minimum duration of 6h. Exclusion Criteria - With history of gastroenteritis in the 2 weeks before hospitalization; - With symptoms suggesting an ongoing gastroenteritis or other intestinal disease; - Use of probiotics or prebiotics within 7 days before admission; - With immunodeficiency, neoplasm or chronic severe illnesses; - With a previous hospitalization within 15 days; - With an history of digestive surgery; - For whom an oral route is impossible; - Participating at the same time in another clinical trial. |
Country | Name | City | State |
---|---|---|---|
France | Centre hospitalier d'Auxerre | Auxerre | |
France | Hopital Robert Debré | Paris |
Lead Sponsor | Collaborator |
---|---|
PiLeJe | Clinact, Clinfile |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of nosocomial diarrhea | The primary endpoint is the comparison of the incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period (or more frequently than is normal for the individual) that occurred between 48 hours to 7 days after admission) between the 2 groups (BABYBIANE® Imedia vs. placebo) during 7 days of supplementation. | during seven days of supplementation | |
Secondary | time to onset of nosocomial diarrhea | Comparison of time to onset of nosocomial diarrhea between the 2 groups | During study duration (14 days) | |
Secondary | number of nosocomial diarrhea | Comparison of the number of nosocomial diarrhea between the 2 groups | During study duration (14 days) | |
Secondary | nosocomial diarrhea duration | Comparison of nosocomial diarrhea duration (defined as the time until the last loose watery stools from the onset of diarrhea that occurs between 48 hours to 7 days after admission) between the 2 groups | During study duration (14 days) | |
Secondary | incidence of diarrhea | Comparison of incidence of diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period (or more frequently than is normal for the individual)) between the 2 groups for the whole duration of a patient's study participation (i.e. 14 days) | During study duration (14 days) | |
Secondary | time to onset of diarrhea | Comparison of time to onset of diarrhea between the 2 groups | During study duration (14 days) | |
Secondary | number of loose or watery stools | Comparison of the number of loose or watery stools between the 2 groups | During study duration (14 days) | |
Secondary | diarrhea duration | Comparison of diarrhea duration (defined as the time until the last loose watery stools from the onset of diarrhea) between the 2 groups | During study duration (14 days) | |
Secondary | incidence of recurrent diarrhea | Comparison of incidence of recurrent diarrhea (after 48 hours of normal stools) between the 2 groups | During study duration (14 days) | |
Secondary | incidence of need for and length of rehydration because of diarrhea | Comparison of incidence of need for and length of rehydration because of diarrhea between the 2 groups | During study duration (14 days) | |
Secondary | length of hospital stay | Comparison of length of hospital stay between the 2 groups | During study duration (14 days) | |
Secondary | number of care visits | Comparison of number of care visits between the 2 groups | During study duration (14 days) | |
Secondary | length of day care missed | Comparison of length of day care missed between the 2 groups | During study duration (14 days) | |
Secondary | length of work missed by parent or guardian | Comparison of length of work missed by parent or guardian between the 2 groups | During study duration (14 days) | |
Secondary | other symptoms presence | Comparison of other symptoms presence between the 2 groups : fever, vomiting, respiratory infections, etc | During study duration (14 days) | |
Secondary | rotavirus, viral or bacterial pathogens' presence on stools | Comparison of rotavirus, viral or bacterial pathogens' presence on stools between the 2 groups | During study duration (14 days) | |
Secondary | adverse events | Comparison of adverse events (rate of patients, type of events, relation with the complementation …) between the 2 groups | During study duration (14 days) | |
Secondary | Complementation intake | Comparison of observance (percentage of diluted complementation consumed per day) between the 2 groups | During study duration (14 days) |
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