Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05211518
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2021-10-04
Brief Title:
Prevention of Inflammatory Bowel Diseases in Persons at Risk The PIONIR Preventing IBD Onset in Individuals at Risk Trial
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Preventing IBD Onset in Individuals at Risk
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PIONIR
Brief Summary:
The goal of this study is to explore in a cross over randomized controlled trial the ability of the TastyHealthy dietary intervention NCT04239248 to alter the parameters associated with future risk of developing Chrons disease CD using subjects identified in the Genetic Environmental Microbiome GEM Study as having a high-risk score Specifically the investigators aim to determine if the TastyHealthy dietary intervention can decrease the overall GEM Risk Score GRS andor to alter the individual biological parameters that contribute to this score The investigators hypothesize that the TastyHealthy dietary approach will alter the risk of CD as reflected by a decrease in the GRS
Detailed Description:
Several important factors associated with CD onset have already been identified in the GEM analyses such as elevated faecal calprotectinFCaltered gut permeability proteomics anti-microbial serology and microbiome composition These parameters are combined into the GEM Risk Score GRS
The first-line therapy in children with CD according to ECCOESPGHAN guidelines is exclusive enteral nutrition EEN meaning 8-12 weeks of exclusive liquid formula Nutritional therapy may alter intestinal inflammation by several mechanisms including modulation of the microbiome and an effect on intestinal permeability both factors assessed in the GEM cohort EEN is safe and effective but it is challenging to implement
Several diets based on solid foods have been proposed as alternatives to EEN in an attempt to increase feasibility three of which have the most data
Specific carbohydrate diet SCD restricts carbohydrates and processed foods and has been long used with variable reported effectiveness
The CD-TREAT diet induced a positive change to the microbiome children with active CD entered clinical remission with decreased inflammatory markers
Crohns Disease Exclusion Diet CDED is based on the exclusion of processed and pro-inflammatory foods similar to TastyHealthy A recent RCT of CDED diet with 50 liquid formula showed comparable effectiveness as EEN including normalization of FC and positive effect on the microbiome
However the allowed dietary components are not liberal and the diet is rigid making it unsuitable as a prevention measure
In 2014 a cook-book named TastyHealthy was published as a simple approach to dietary treatment based on the best available evidence A steering committee of physicians experienced in IBD and nutrition as well as leading IBD dieticians reviewed results of dietary studies from animal models humans and epidemiological cohorts This review resulted in agreed-upon foods that may aggravate inflammation and thus should be excluded including all processed and industrialized food animal fat dairy meat gluten and sugar Overall allowed foods in liberal quantities are those prepared at home from readily available ingredients such as fruits vegetables fish and shellfish poultry oats eggs non-gluten grains and legumes TastyHealthy is not a specific diet it is a dietary approach in which the allowed foods are not structured or restricted This approach allows flexibility to increase adherence In this study The Investigators hypothesize that the TastyHealthy dietary approach will alter the risk of CD as reflected by a decrease in the GEM CD risk score or alteration of its individual components
The first-line therapy in children with CD according to ECCOESPGHAN guidelines is exclusive enteral nutrition EEN meaning 8-12 weeks of exclusive liquid formula Nutritional therapy may alter intestinal inflammation by several mechanisms including modulation of the microbiome and an effect on intestinal permeability both factors assessed in the GEM cohort EEN is safe and effective but it is challenging to implement
Several diets based on solid foods have been proposed as alternatives to EEN in an attempt to increase feasibility three of which have the most data
Specific carbohydrate diet SCD restricts carbohydrates and processed foods and has been long used with variable reported effectiveness
The CD-TREAT diet induced a positive change to the microbiome children with active CD entered clinical remission with decreased inflammatory markers
Crohns Disease Exclusion Diet CDED is based on the exclusion of processed and pro-inflammatory foods similar to TastyHealthy A recent RCT of CDED diet with 50 liquid formula showed comparable effectiveness as EEN including normalization of FC and positive effect on the microbiome
However the allowed dietary components are not liberal and the diet is rigid making it unsuitable as a prevention measure
In 2014 a cook-book named TastyHealthy was published as a simple approach to dietary treatment based on the best available evidence A steering committee of physicians experienced in IBD and nutrition as well as leading IBD dieticians reviewed results of dietary studies from animal models humans and epidemiological cohorts This review resulted in agreed-upon foods that may aggravate inflammation and thus should be excluded including all processed and industrialized food animal fat dairy meat gluten and sugar Overall allowed foods in liberal quantities are those prepared at home from readily available ingredients such as fruits vegetables fish and shellfish poultry oats eggs non-gluten grains and legumes TastyHealthy is not a specific diet it is a dietary approach in which the allowed foods are not structured or restricted This approach allows flexibility to increase adherence In this study The Investigators hypothesize that the TastyHealthy dietary approach will alter the risk of CD as reflected by a decrease in the GEM CD risk score or alteration of its individual components
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