Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016322
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-08-08
Brief Title:
Dried Chicory Root in IBD
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
The Effect of Dried Chicory Root on Inflammation Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
Chic-IBD
Brief Summary:
The goal of this clinical pilot trial is to test the use of dried chicory root in patients with IBD The main questions it aims to answer are
what the effect of a 4-week 10-20 gday WholeFiberTM intervention on fecal calprotectin IBD-complaints and QoL serum inflammatory markers gut microbiota and SCFA levels in patients with Crohns disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks equals 85 g fiber and 2 sachets of 10g WholeFiberTM per day for the last two weeks equals 17 g fiber
Researchers will compare the above mentioned outcomes before and after the intervention
what the effect of a 4-week 10-20 gday WholeFiberTM intervention on fecal calprotectin IBD-complaints and QoL serum inflammatory markers gut microbiota and SCFA levels in patients with Crohns disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks equals 85 g fiber and 2 sachets of 10g WholeFiberTM per day for the last two weeks equals 17 g fiber
Researchers will compare the above mentioned outcomes before and after the intervention
Detailed Description:
Rationale Inflammatory Bowel Diseases IBD of which Ulcerative Colitis UC and Crohns Disease CD are the main types includes recurring episodes of inflammation in the gastro-intestinal tract and severely impacts quality of life QoL leads to more hospitalization and increases the mortality risk An impaired gut microbiota and lower levels of short-chain fatty acids SCFA have been linked to the pathophysiology A higher fiber intake is linked to positive changes in the gut microbiota and increase SCFA-production however patients with IBD consume too little dietary fiber WholeFiberTM a dried vegetable rich in 4 types of prebiotic fiber may be an easy solution to increase dietary fiber intake impact the gut microbiota and SCFA IBD-complaints and health parameters
Objective To explore the effect of a 4-week 10-20 gday WholeFiberTM intervention on fecal calprotectin IBD-complaints and QoL serum inflammatory markers gut microbiota and SCFA levels in patients with CD and UC
Study design this is a 4-week pilot study with one arm to explore the effects of a WholeFiberTM intervention Measurements will take place before and after the intervention questionnaires will also be conducted halfway
Study population in total 12 patients with mild to moderate IBD complaints will be included of which 6 UC and 6 CD patients to investigate if there is a difference between the two groups in efficacy of WholeFiberTM
Intervention Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks equals 85 g fiber and 2 sachets of 10g WholeFiberTM per day for the last two weeks equals 17 g fiber
Main study parametersendpoints the primary parameter is change in fecal calprotectin after the 4-week intervention which is a marker for inflammation in the gut Secondary parameters are improvements in IBD-complaints QoL serum markers and changes in the gut microbiota and increase in fecal SCFA-production Moreover it will be explored whether the response on the intervention will be different between UC and CD Furthermore an evaluation questionnaire will be conducted to assess feasibility and acceptance of the WholeFiberTM intervention in this population
Objective To explore the effect of a 4-week 10-20 gday WholeFiberTM intervention on fecal calprotectin IBD-complaints and QoL serum inflammatory markers gut microbiota and SCFA levels in patients with CD and UC
Study design this is a 4-week pilot study with one arm to explore the effects of a WholeFiberTM intervention Measurements will take place before and after the intervention questionnaires will also be conducted halfway
Study population in total 12 patients with mild to moderate IBD complaints will be included of which 6 UC and 6 CD patients to investigate if there is a difference between the two groups in efficacy of WholeFiberTM
Intervention Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks equals 85 g fiber and 2 sachets of 10g WholeFiberTM per day for the last two weeks equals 17 g fiber
Main study parametersendpoints the primary parameter is change in fecal calprotectin after the 4-week intervention which is a marker for inflammation in the gut Secondary parameters are improvements in IBD-complaints QoL serum markers and changes in the gut microbiota and increase in fecal SCFA-production Moreover it will be explored whether the response on the intervention will be different between UC and CD Furthermore an evaluation questionnaire will be conducted to assess feasibility and acceptance of the WholeFiberTM intervention in this population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KIEMK2301148 | OTHER_GRANT | NWO | None |