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.: PACTR202404560083036 Date of Approval: 08/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Crohn’s disease exclusion diet (CDED): An adjuvant therapy with biologics in management of pediatric Crohn’s disease
Official scientific title Crohn’s disease exclusion diet (CDED): An adjuvant therapy with biologics in management of pediatric Crohn’s disease
Brief summary describing the background and objectives of the trial Exclusive enteral nutrition (EEN) is observed with high remission rates, which is recommended as a first line treatment for pediatric CD. Crohn’s disease exclusion diet (CDED) is a whole food diet combined with partial enteral nutrition (PEN) and excluding the amount of dietary components that have negative effects on the intestine (Levine et al., 2019).CDED usually consists of two to three phases that change every 6weeks, with each stage of the diet allowing access to a wider range of specific foods that gradually become easier for the patient. The first phase is the most restrictive, limiting the amount of certain fruits and vegetables in addition to eliminating foods and dietary components that trigger inflammation. PEN, which generally uses polymeric formula (Modulen) is added to meet 50% of energy demand. The second phase allows for a wider variety of foods and almost all fruits and vegetables can be allowed in the final weeks of this phase. PEN is reduced to provide 25% of energy demand (Zhu et al., 2023). After 12 weeks of dietary treatment, the maintenance phase begins, with the diet balanced by free meals, allowing intermittent and controlled exposure to certain foods that were not allowed in the first phase. It is recommended to maintain PEN to cover 25% of energy requirements (López et al., 2020) Objectives:1.To compare the efficacy of combined biological and conventional therapy (5-aminosalicylic acid, and azathioprine) versus combined biological and conventional therapy with CDED regarding disease remission, maintenance and complications. 2. To assess the effect of CDED on the nutritional status of patients with an active Crohn’s disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 01/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dietry intervention for 6 months The children will randomly assign to a group that will receive CDED plus 50% of calories from the formula (Modulen) for 6 weeks (stage 1) followed by CDED with 25% PEN from weeks 7 to 12 (stage 2) followed by healthy diet with avoiding highly processed foods with 25% PEN from weeks 12 to 24 (stage 3) (n = 15, group B) or a group that received medical therapy with regular diet (n = 15, group A). The study will include 4 visits—baseline (at week 0) at the end of phase 1 (i.e., after 6 weeks) and phase 2 (i.e., after 12 weeks) and after 6 months of the nutritional therapy. At each visit, nutritional status (weight, body length, and BMI) and clinical disease activity (PCDAI scale) will be assessed and inflammatory parameters (CRP, ESR, and fecal calprotectin level) will be analyzed. All patients will receive ongoing supervision from a gastroenterologist and a nutritionist trained in the rules of the nutritional intervention used. 15
Control Group no intervention 6 months no intervention 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with an active Crohn’s disease on biological treatment and conventional treatment. Age between 5-18 years. Children with Crohn’s disease on steroid therapy course. Children less than 5 years old. Patient with any other causes of chronic diarrhea e.g ( congenital, metabolic causes…etc) Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 5 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 28/02/2024 The Research Ethics Committee of the faculty of medicine cairo university
Ethics Committee Address
Street address City Postal code Country
Fourth floor adminstrtation Buliding Faculity of Medicine- cairo university cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the efficacy of combined biological and conventional treatment (5-aminosalicylic acid, and azathioprine) versus combined biological and Crohn’s disease exclusion diet regarding disease course, remission, and it`s maintenance. AT the end of each stage of the intervention, 6weeks, 3months, 6 months
Secondary Outcome To assess the effect of CDED on the nutritional status of patients with an active Crohn’s disease. AT the end of each stage of the intervention, 6weeks, 3months, 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
pediatric gastroenterology outpatient clinic at Abo el reesh hospital kasr Alainy street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university Faculity of Medicine- cairo university cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university Cairo Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Emil Eskander. dr.aymanemil@yahoo.com 00201223993369 madinet nasr
City Postal code Country Position/Affiliation
cairo Egypt Professor of Pediatric gastroenterology
Role Name Email Phone Street address
Public Enquiries Marwa Ahmed Sedkey marwasedkey@kasralainy.edu.eg 00201145712208 maniel
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of pediatric
Role Name Email Phone Street address
Scientific Enquiries Amera Mohammed Hasnoon amerahasnoon0@gmail.com 00201204000805 hadayek el ahram
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of pediatric
Role Name Email Phone Street address
Scientific Enquiries Wesam Zakariah dr.weso.1994@gmail.com 00201149994005 Maadi
City Postal code Country Position/Affiliation
Cairo Egypt Asisstant Lecturer of pediatric
Role Name Email Phone Street address
Scientific Enquiries Marwa Ahmed Sedkey marwasedkey@kasralainy.edu.eg 00201145712208 maniel
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of pediatric
Role Name Email Phone Street address
Public Enquiries Amera Mohammed Hasnoon amerahasnoon0@gmail.com 00201204000805 hadayek el ahram
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of pediatric
Role Name Email Phone Street address
Public Enquiries Wesam Ahmed Zakariah dr.weso.1994@gmail.com 00201149994005 Maadi
City Postal code Country Position/Affiliation
cairo Egypt Asisstant Lecturer of pediatric
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication With investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
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