Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388330
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2020-05-06
Brief Title:
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms Postprandial Distress Syndrome According to the Rome IV Consensus
Status:
COMPLETED
Status Verified Date:
2024-04
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:
FFD
Brief Summary:
In this study the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD
Detailed Description:
The study design starts with a baseline period of 2 weeks includes 6 weeks of a strict FODMAP diet no blinded followed by a 9 week reintroduction phase single blind Based on the patients symptom results following each of these challenges patients will then follow the moderate FODMAP diet where the FODMAPs that did not trigger any symptoms during the challenge tests can now be consumed Finally patients follow 2 weeks of a diet moderate in FODMAP levels no blinded Blood and stool samples will be collected during the complete trial at several timepoints In addition before and after the strict diet phase a gastroscopy will be performed as well as an intragastric pressure measurement and breath test
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