Dried Chicory Root in IBD — Chic-IBD  

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial 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 g/day WholeFiberTM intervention on fecal calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 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.

Clinical Trial Description

Rationale: Inflammatory Bowel Diseases (IBD), of which Ulcerative Colitis (UC) and Crohn's 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 g/day 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 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber).

Main study parameters/endpoints: 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. ;

Related Conditions & MeSH terms

• Dietary Exposure
• Inflammatory Bowel Diseases
• Intestinal Diseases

• NCT number: NCT06016322
• Study type: Interventional
• Source: University Medical Center Groningen
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2, 2023
• Completion date: September 30, 2024