Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405774358342 Date of Approval: 08/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation Of Lactobacillus As Adjuvant Among Pediatric Intensive Care Admissions In An Attempt To Prevent Acquiring Nosocomial Infections
Official scientific title Evaluation Of Lactobacillus As Adjuvant Among Pediatric Intensive Care Admissions In An Attempt To Prevent Acquiring Nosocomial Infections
Brief summary describing the background and objectives of the trial Probiotics are available as single microbial strain (e.g. bacillus clausii, lactobacillus) or a mix of multiple strains of lactobacillis (acidophilus, sporogenes, lactis,reuteri RC-14, and L.plantarum 299v), Bifidobacteriae (bifidum, longum, infantis ), streptococcus, Saccharomyces boulardii. Hospital Acquired Infections (HAI) are all infections that occur during patient’s hospitalization and not present or incubating at admission. Also, any infection that appears to have been acquired in hospital but does not manifest until after discharge is judged to be a nosocomial infection. Therefore, all infections diagnosed 48 hours after admission till 72 hours after discharge should be considered as nosocomial. This study is designed to assess the effect of administration of probiotics lactobacillus to prevent acquiring of nosocomial infection to all critically ill patients admitted in the pediatric intensive care unit (PICU) of Alexandria University.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied nosocomial infection in critically ill patients admitted in the pediatric intensive care unit
Purpose of the trial Prevention
Anticipated trial start date 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 196
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lacteol forte and linex lacteol forte with a concentration of 10 billion lactobacillus fermentum and delbruekii linex 1 billion lactobacillus acidophillus and 1 billion Bifidobacterium animalis subspecies lactis Daily Oral administration until PICU discharge Daily oral administration till PICU discharge 98
Control Group Placebo Placebo (starch of the same weight and packaging) Administered orally daily until PICU discharge Administered orally daily until PICU discharge 98 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All admitted patients to the PICU - All surgical cases. - Patients with suspicion of gastrointestinal perforation or obstruction. - Patients with neutropenia (less than or equal 0.5×109 cells/ liter). - Patients with history of chronic immunological diseases or receiving immunosuppressive drugs for the previous 3 months before admission. - Oncological patients on treatment. - Patients on breast feeding during the PICU stay. - Patients receiving probiotics in the 2 weeks before admission - Patients with absolute contraindication to eternal medication - Patients with Acute pancreatitis. - Patients deceased within the first 72 hours from admission Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Month(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2023 The ethics committee of the Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, E Messalah Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hospital Acquired Infections During PICU stay and until 72 hourrs after discharge
Secondary Outcome Length of PICU stay. From PICU admission till PICU discharge
Secondary Outcome Length of hospitalization From hospital admission till hospital dischrage
Primary Outcome 28-days mortality During the first 28 days of PICU administration or till discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric intensive care unit El Shatby hospital Alexandria University Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rowan Fawzy Ahmed Ibrahim Elshamy 94 Kamal Eldeen Salah Smouha Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department Faculty of Medicine Alexandria University Portsaid street, El Shatby Alexandri a 21563 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El nawawy Portsaid street, El Shatby Alexandria 21563 Egypt
Manal Abdel Malik Antonios Portsaid street, El Shatby Alexandria 21563 Egypt
Rowan Fawzy Ahmed Ibrahim Elshamy 94 Kamal Eldeen Salah Smouha Alexandria 21648 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Nawawy dr_anawawy@yahoo.com 002034831061 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Professor of Pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Manal Antonios malakmanal@yahoo.com 00201229733422 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Professor of Pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information