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.: PACTR202311873054587 Date of Approval: 21/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Probiotics as Adjuvant Therapy in Newly Diagnosed Immune Thrombocytopenia in Children
Official scientific title Role of Probiotics as Adjuvant Therapy in Newly Diagnosed Immune Thrombocytopenia in Children
Brief summary describing the background and objectives of the trial Immune thrombocytopenia (ITP) is one of the most common acquired bleeding disorders. Although the pathophysiology of ITP is incompletely understood, it is believed to result from the production of autoreactive antibodies targeting endogenous platelets for destruction and alterations in cellular immunity, as well as impaired megakaryopoiesis and platelet production. Disruption of the gut microbiome, termed dysbiosis is associated with an imbalance between populations of inflammation-mediating T-helper cells (Th1, Th2 and Th17) and anti inflammatory T-regulatory cells. ITP was reported to be improved by transplantation of fecal microbiota, this suggests a potential role of gut microbiota in the pathogenesis of primary ITP .The aim of this study is to evaluate role of probiotics as adjuvant therapy in newly diagnosed immune thrombocytopenia in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2023
Actual trial start date
Anticipated date of last follow up 01/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group prednisone 2 mg/kg/day (maximum 60 mg/day) for 1 week standard ITP treatment 30 Active-Treatment of Control Group
Experimental Group prednisone and probiotics prednisone : 2 mg/kg/day (maximum 60 mg/day) for 1 week probiotics (enterogermia, Bacillus clausii ) : 1or 2 mini bottle (2 billions /5ml oral suspension) daily prednisone for 1 week probiotics (enterogermia, Bacillus clausii ) for 2 weeks . standard treatment plus adjuvant probiotics 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 1–18 years with primary ITP having platelet count <30,000 /µL Patients with secondary ITP including leukemia, drugs, lupus erythematous, cirrhosis, HIV, hepatitis C, antiphospholipid syndrome, von-Willebrand factor deficiency. Previous probiotic or antibiotic treatment for the past 4 weeks. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 12 Month(s) 18 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 10/05/2023 Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Govenorate, El-Gash st. Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome early response, initial response, and durable response and remission rates in both groups 1 week , 1 month , 3 month
Secondary Outcome bleeding score , steroid related side effects 1 week , 1 month , 3 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El-Gharbia Govenorate, El-Gash st. Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El-Gharbia Govenorate,El-Gash st. Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman Mohammed Elaskary El-Gharbia Govenorate, El-Gash st. Tanta 31527 Egypt
Soma Ibrahim Attia Mansour El-Gharbia Govenorate, El-Gash st. Tanta 31527 Egypt
Mohamed Ramadan Elshanshory El-Gharbia Govenorate, El-Gash st. Tanta 31527 Egypt
Rasha Adel Elkholy El-Gharbia Govenorate,El-Gash st. Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Elaskary eman_elaskary@yahoo.com +201003007638 El-Gharbia Govenorate,El-Gash st.
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Pediatrics
Role Name Email Phone Street address
Public Enquiries Mohamed Elshanshory elshanshory@gmail.com +201005680834 El-Gharbia Govenorate, El-Gash st.
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elshanshory elshanshory@gmail.com +201005680834 El-Gharbia Govenorate,El-Gash st.
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share de-identified individual trial participant data. All of the individual participant data collected during the trial and after deidentification will be available for anyone who wishes to access the data for any purpose. Statistical Analysis Plan,Study Protocol After completion of research and publication of the paper on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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