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Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children (EPISODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04628819
Recruitment Status : Terminated (Not enough patients included)
First Posted : November 16, 2020
Last Update Posted : April 20, 2021
Sponsor:
Collaborators:
Clinact
Clinfile
Information provided by (Responsible Party):
Larena SAS ( PiLeJe )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Nosocomial Infection Diarrhea, Infantile Dietary Supplement: Babybiane Imedia or placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized in one of the two parallel groups. The first group will be supplemented with Lactobacillus Rhamnosus and the second group will intake a placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The patients, their parents and the investigators will not know the treatment taken by the patient. Unblinding will be performed at the end of the study.
Primary Purpose: Prevention
Official Title: Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children
Actual Study Start Date : December 29, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020


Arm Intervention/treatment
Experimental: Babybiane Imedia
Patients receive Babybiane Imedia once daily during seven days.
Dietary Supplement: Babybiane Imedia or placebo
Both the investigational product as well as the placebo will be administered once daily, diluted in a nursing bottle or a glass of water or cold milk, or mixed with a food suitable for the child. It may be diluted in oral rehydration solution and is to be taken preferably before a meal. Both preparations (BABYBIANE® Imedia and placebo) will have similar consistency and taste. A supplementation unit will contain 7 packs of either products, one per supplementation day.

Placebo Comparator: Placebo
Patients receive a placebo with the same consistency and taste as the Babybiane Imedia once daily during seven days.
Dietary Supplement: Babybiane Imedia or placebo
Both the investigational product as well as the placebo will be administered once daily, diluted in a nursing bottle or a glass of water or cold milk, or mixed with a food suitable for the child. It may be diluted in oral rehydration solution and is to be taken preferably before a meal. Both preparations (BABYBIANE® Imedia and placebo) will have similar consistency and taste. A supplementation unit will contain 7 packs of either products, one per supplementation day.




Primary Outcome Measures :
  1. incidence of nosocomial diarrhea [ Time Frame: during seven days of supplementation ]
    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.


Secondary Outcome Measures :
  1. time to onset of nosocomial diarrhea [ Time Frame: During study duration (14 days) ]
    Comparison of time to onset of nosocomial diarrhea between the 2 groups

  2. number of nosocomial diarrhea [ Time Frame: During study duration (14 days) ]
    Comparison of the number of nosocomial diarrhea between the 2 groups

  3. nosocomial diarrhea duration [ Time Frame: During study duration (14 days) ]
    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

  4. incidence of diarrhea [ Time Frame: During study duration (14 days) ]
    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)

  5. time to onset of diarrhea [ Time Frame: During study duration (14 days) ]
    Comparison of time to onset of diarrhea between the 2 groups

  6. number of loose or watery stools [ Time Frame: During study duration (14 days) ]
    Comparison of the number of loose or watery stools between the 2 groups

  7. diarrhea duration [ Time Frame: During study duration (14 days) ]
    Comparison of diarrhea duration (defined as the time until the last loose watery stools from the onset of diarrhea) between the 2 groups

  8. incidence of recurrent diarrhea [ Time Frame: During study duration (14 days) ]
    Comparison of incidence of recurrent diarrhea (after 48 hours of normal stools) between the 2 groups

  9. incidence of need for and length of rehydration because of diarrhea [ Time Frame: During study duration (14 days) ]
    Comparison of incidence of need for and length of rehydration because of diarrhea between the 2 groups

  10. length of hospital stay [ Time Frame: During study duration (14 days) ]
    Comparison of length of hospital stay between the 2 groups

  11. number of care visits [ Time Frame: During study duration (14 days) ]
    Comparison of number of care visits between the 2 groups

  12. length of day care missed [ Time Frame: During study duration (14 days) ]
    Comparison of length of day care missed between the 2 groups

  13. length of work missed by parent or guardian [ Time Frame: During study duration (14 days) ]
    Comparison of length of work missed by parent or guardian between the 2 groups

  14. other symptoms presence [ Time Frame: During study duration (14 days) ]
    Comparison of other symptoms presence between the 2 groups : fever, vomiting, respiratory infections, etc

  15. rotavirus, viral or bacterial pathogens' presence on stools [ Time Frame: During study duration (14 days) ]
    Comparison of rotavirus, viral or bacterial pathogens' presence on stools between the 2 groups

  16. adverse events [ Time Frame: During study duration (14 days) ]
    Comparison of adverse events (rate of patients, type of events, relation with the complementation …) between the 2 groups

  17. Complementation intake [ Time Frame: During study duration (14 days) ]
    Comparison of observance (percentage of diluted complementation consumed per day) between the 2 groups



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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628819


Locations
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France
Centre hospitalier d'Auxerre
Auxerre, France
Hopital Robert Debré
Paris, France
Sponsors and Collaborators
PiLeJe
Clinact
Clinfile
Investigators
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Principal Investigator: Alexis Mosca, MD Robert Debré Hospital
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Responsible Party: PiLeJe
ClinicalTrials.gov Identifier: NCT04628819    
Other Study ID Numbers: 2019-A01797-50
2019-A01797-50 ( Other Identifier: ANSM (ID-RCB) )
19.07.30.37834 ( Other Identifier: CNRIPH (French Ethic Committee) )
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Larena SAS ( PiLeJe ):
Lactobacillus Rhamnosus
Children
Dietary Supplementation
Preventive nutritional care
Additional relevant MeSH terms:
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Cross Infection
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes