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.: PACTR202003564365054 Date of Registration: 02/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of the Mediterranean Diet in Children and Adolescents with Active Inflammatory Bowel Diseases
Official scientific title Effects of the Mediterranean Diet in Children and Adolescents with Active Inflammatory Bowel Diseases
Brief summary describing the background and objectives of the trial Mediterraneandiet (MD) is a well-known pattern of diet full of antioxidants and probably has an anti-inflammatory effects. We will evaluate the safety, tolerability and the effects of adherence to MD on disease activity and inflammatory markers in children and adolescents with active inflammatory bowel disease (IBD).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2020
Actual trial start date
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mediterranean diet group they will follow mediterranean diet for 12 week 12 weeks 50 children with IBD will be included and they will receive Mediterranean Diet for 12 weeks beside their regular treatment. Initial evaluation of all subjects will include history, physical examination and laboratory tests such as CBC, CRP, ESR, albumin, serum levels of TNF- α, IL17, IL10, IL 12 and IL13 as well as stool calprotectin level. Follow up visits will be at 2, 4, 8 and 12 weeks. During each follow up visit, ESR, CRP, serum albumin levels, and disease activity by PCDAI or PUCAI will be evaluated. Stool calprotectin, serum levels of TNF- α, IL17, IL10, IL 12 and IL13 will be carried out at weeks 4 and 12. Growth parameters (body weight, height and BMI) beside serum levels of calcium, PTH, vitaminD, triglecerides. cholesterol,glucose and hemoglobin levels will be measured at start and at the end of our study. 50
Control Group none regular diet and regular treatment 12 weeks 50 children with IBD will be included and they will be on their regular diet and regular treatment with no intervention for 12 weeks. Initial evaluation of all subjects will include history, physical examination and laboratory tests such as CBC, CRP, ESR, albumin, serum levels of TNF- α, IL17, IL10, IL 12 and IL13 as well as stool calprotectin level. Follow up visits will be at 2, 4, 8 and 12 weeks. During each follow up visit, ESR, CRP, serum albumin levels, and disease activity by PCDAI or PUCAI will be evaluated. Stool calprotectin, serum levels of TNF- α, IL17, IL10, IL 12 and IL13 will be carried out at weeks 4 and 12. Growth parameters (body weight, height and BMI) beside serum levels of calcium, PTH, vitaminD, triglecerides. cholesterol,glucose and hemoglobin levels will be measured at start and at the end of our study. 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children and adolescents (12-18 years) Patients with IBD with mild or moderate disease activity as defined by PCDAI score of 10-45 or PUCAI of 10 to 64 History of GIT operation *Pregnancy or desire to be pregnant within study period *Systemic disorders e.g. cardiac, renal,pulmonary,endocrine…etc *Psychiatric disorder *Unable to comply with study requirements *Unable or unwilling to consent *Presence of alcohol or drug abuse. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 12 Year(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 29/01/2020 Local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
Elgiesh street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of Mediterranean diet on the activity of the disease before and at 2,4,8, and 12 weeks
Secondary Outcome effect of Mediterranean diet on inflammatory markers before and at 4 and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University hospital elgheish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa El Amrousy Elmotasem street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine of tanta university elgeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Samir Hassan elnady street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com 00201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Samir Hassan samirhasan72@gmail.com 00201092491020 Elnady street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Heba El Ashry Hebae92@gmail.com +201223180650 Elnady street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of tropical medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study protocol and statistical analysis plan will be shared in a word document format Statistical Analysis Plan,Study Protocol after publication of the paper controlled access after approval of the authors
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