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

NCT04628819 | Terminated

• 2 other identifiers: 2019-A01797-5019.07.30.37834
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Nosocomial Infection; Diarrhea, Infantile

Keywords

Lactobacillus Rhamnosus; Children; Dietary Supplementation; Preventive nutritional care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• time to onset of nosocomial diarrhea

  During study duration (14 days)

• number of nosocomial diarrhea

  During study duration (14 days)

• nosocomial diarrhea duration

  During study duration (14 days)

• incidence of diarrhea

  During study duration (14 days)

• time to onset of diarrhea

  During study duration (14 days)

Study Arms (2)

Babybiane Imedia

EXPERIMENTAL

Patients receive Babybiane Imedia once daily during seven days.

Dietary Supplement: Babybiane Imedia or placebo

Placebo

PLACEBO COMPARATOR

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

Interventions

Babybiane Imedia or placebo DIETARY_SUPPLEMENT

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.

Babybiane Imedia; Placebo

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PiLeJe: lead
• Clinact: collaborator
• Clinfile: collaborator

Study Sites (2)

Centre hospitalier d'Auxerre

Auxerre, France

Location

Hopital Robert Debré

Paris, France

Location

MeSH Terms

Conditions

Cross Infection; Diarrhea, Infantile

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Alexis Mosca, MD

  Hopital Universitaire Robert-Debre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: December 29, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)