Dried Chicory Root in IBD (Chic-IBD)

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Dietary Exposure; Inflammatory Bowel Diseases

Treatments: Dietary Supplement: Dried Chicory Root

Study type: Interventional

Funder types: Other

Identifiers

NCT06016322

NL85061.042.23

KIEM.K23.01.148 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged ≥18 years;
• Having a diagnosis of IBD (either UC or CD) and undergoing treatment at the policlinic at the University Medical Center Groningen;
• Mild or moderate IBD, defined as fecal calprotectin levels ≥100 μg and Harvey Bradshaw Index (HBI) <8 for CD patients or Simple Clinical Colitis Activity Index (SCCAI) <5 for UC patients;
• Using stable maintenance therapy for at least 12 weeks;
• Being able to read and speak Dutch;
• Willing to come to the University Medical Center Groningen for practical reasons (visiting the study site);
• Willing to continue their regular lifestyle patterns during the study.

Exclusion criteria

• Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, cancer, celiac disease;
• Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbiota composition;
• Having a clinically significant stenosis;
• Use of antibiotics <4 weeks before study start;
• Use of prebiotics, probiotics and/or synbiotic (this should be stopped 4 weeks before start of the study) or other fiber supplements such as psyllium;
• Use of tube feeding or sib-feeding;
• Being pregnant or lactating;
• Participation in another clinical study at the same time;
• Unable or unwilling to comply to study rules

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Before and after study in 6 patients with UC and 6 patients wiht CD

Experimental group

Description:

This is a 4-week before-after pilot study to explore the effectiveness of a WholeFiber Trademark (TM) intervention (a dried vegetable rich in prebiotic intrinsic fibers) on inflammation, fecal gut microbiota and metabolites, IBD-complaints and QoL and assesses its feasibility. In this before-after study, 12 patients with IBD will receive WholeFiberTM; of which 6 patients with CD and 6 patients with UC to assess if there is a difference in effect between these groups of patients.

Treatment:

Dietary Supplement: Dried Chicory Root