Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474546
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-05
Brief Title:
Feasibility of a Diet Intervention for Juvenile Arthritis
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
The Role of Diet as Mediated by the Gut Microbiome on Childhood Arthritis Disease Activity a Feasibility Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
DIGEST-JA
Brief Summary:
Families of children with arthritis are highly interested in the benefits of diet to improve their childs disease and future health outcomes Previous research shows that the germs - bacteria and other organisms - that live in the intestines gut microbiome are important to how well immune systems work and that what people eat changes their gut microbiome The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement
Fifty-four participants in this study will change their diet for an 8-week period and will have the option of remaining on the diet for an additional 4 weeks At three time points during the study beginning 8 weeks and 12 weeks participants will provide stool and blood samples will complete questionnaires about diet and other aspects of lifestyle and health and will complete a disease assessment by a clinician From collecting all these samples and information the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well
This study will help the investigators figure out if a larger and more definitive study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis If successful this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic
Fifty-four participants in this study will change their diet for an 8-week period and will have the option of remaining on the diet for an additional 4 weeks At three time points during the study beginning 8 weeks and 12 weeks participants will provide stool and blood samples will complete questionnaires about diet and other aspects of lifestyle and health and will complete a disease assessment by a clinician From collecting all these samples and information the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well
This study will help the investigators figure out if a larger and more definitive study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis If successful this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic
Detailed Description:
None
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