Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920187
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-03-18
Brief Title:
Dietary Intervention for Inflammatory Bowel Disease Remission
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Additive Modified Mediterranean Dietary Intervention Versus Modified Anti-inflammatory Dietary Intervention for Inflammatory Bowel Disease Remission
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To compare adding dietary intervention based on MD to dietary intervention based on IBD-AID on induction of disease remission of IBD patients receiving pharmacotherapy
2 To compare patients adherence to dietary intervention based on MD to dietary intervention based on IBD-AID and the impact of adherence on induction of remission among patients with IBD receiving pharmacotherapy
2 To compare patients adherence to dietary intervention based on MD to dietary intervention based on IBD-AID and the impact of adherence on induction of remission among patients with IBD receiving pharmacotherapy
Detailed Description:
Inflammatory bowel disease IBD is a chronic inflammatory disorder with two major types ulcerative colitis UC and Crohns disease CD There is a growing incidence of IBD in the Arab world with incidence rate of 233 per 100000 persons per year for UC and 146 per 100000 persons per year for CD
Due to this increasing incidence it is likely that IBD will become a major health problem in the future
Pathogenesis of IBD is not fully understood yet recent studies suggest that IBD is associated with a multifactorial process involving genetics environmental factors microbiota and deregulation of the immune system
Diet is one of the environmental factors involved in the onset and course of IBD Accumulating evidence points to gut dysbiosis combined with aberrant immune response in genetically predisposed individuals a process probably triggered and maintained by changes in environmental factors including diet the exact interplay between these factors is still unknown
Since the prevalence of IBD is highest in the Western world affecting up to 05 of the general population in 2015 it is thought that the Western diet high in fats and sugars and low in vegetables and fruits contributes to the development of IBD
Several diets have been proposed for the treatment or prevention of different diseases One of the most widely used is the Mediterranean diet MD which was recently suggested for management of several diseases The traditional Mediterranean diet is characterized by high consumption of vegetables fruits olive oil nuts and legumes as well as fish and unprocessed cereals low intake of meat meat products and dairy products
Another diet the IBD anti-inflammatory diet AID which restricts intake of certain carbohydrates and includes pre- and probiotic foods and modified dietary fatty acids showed some improvements in a case series study as adjunct dietary therapy for treatment of IBD patient
Application of healthier dietary patterns has been considered effective non-invasive and long-lasting therapy Therapeutic diets should be evaluated as an adjunct therapy to reduce number andor dose of IBD medications with consequent reduction of cost and adverse effects However high-quality data to guide the dietary recommendations are still lacking
Due to this increasing incidence it is likely that IBD will become a major health problem in the future
Pathogenesis of IBD is not fully understood yet recent studies suggest that IBD is associated with a multifactorial process involving genetics environmental factors microbiota and deregulation of the immune system
Diet is one of the environmental factors involved in the onset and course of IBD Accumulating evidence points to gut dysbiosis combined with aberrant immune response in genetically predisposed individuals a process probably triggered and maintained by changes in environmental factors including diet the exact interplay between these factors is still unknown
Since the prevalence of IBD is highest in the Western world affecting up to 05 of the general population in 2015 it is thought that the Western diet high in fats and sugars and low in vegetables and fruits contributes to the development of IBD
Several diets have been proposed for the treatment or prevention of different diseases One of the most widely used is the Mediterranean diet MD which was recently suggested for management of several diseases The traditional Mediterranean diet is characterized by high consumption of vegetables fruits olive oil nuts and legumes as well as fish and unprocessed cereals low intake of meat meat products and dairy products
Another diet the IBD anti-inflammatory diet AID which restricts intake of certain carbohydrates and includes pre- and probiotic foods and modified dietary fatty acids showed some improvements in a case series study as adjunct dietary therapy for treatment of IBD patient
Application of healthier dietary patterns has been considered effective non-invasive and long-lasting therapy Therapeutic diets should be evaluated as an adjunct therapy to reduce number andor dose of IBD medications with consequent reduction of cost and adverse effects However high-quality data to guide the dietary recommendations are still lacking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None