Clinical trial NCT06016322: Dried Chicory Root in IBD
Official title: The Effect of Dried Chicory Root on Inflammation, Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Dietary Exposure
Keywords: Inflammatory bowel disease
dietary fiber
gut microbiome
inflammation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: WholeFiber
name: MyMicroZoo
First posted: 2023-08-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study investigating the effect of additional dietary intake 10-20 gram of a dried vegetable fibre. The difference in outcomes before and after the intervention in fecal calprotectin, IBD complaints, QOL, serum inflammatory markers, gut microbiota and SCFA will be determined
Primary purpose: SUPPORTIVE_CARE

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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in fecal calprotectin
timeFrame: difference between baseline and after 4-week intervention
Secondary outcomes:
measure: Change in IBD complaints by HBI for CD
timeFrame: difference between baseline and after 4-week intervention
measure: Change in IBD complaints by SCCAI for UC
timeFrame: difference between baseline and after 4-week intervention
measure: Change in QOL measured by IBDQ
timeFrame: difference between baseline and after 4-week intervention
measure: Change in the Food-related Quality of Life (FrQOL)
timeFrame: difference between baseline and after 4-week intervention
measure: Change in stool consistency
timeFrame: difference between baseline and after 4-week intervention
measure: Change in stool frequency
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal microbiota composition: Shannon-index
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal microbiota composition by beta-diversity
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal SCFA levels: lactate
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal SCFA levels: formate
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal SCFA levels; butyrate
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal SCFA levels: propionate
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal SCFA levels: acetate
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal acidity (pH)
timeFrame: difference between baseline and after 4-week intervention
measure: Change in fecal redox status
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum leukocytes
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum thrombocytes
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum iron status: serum iron
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum iron status: Total Iron Binding Capacity (TIBC)
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum iron status: ferritin
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum iron status: transferrin
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum ALAT
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum ASAT
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum GGT
timeFrame: difference between baseline and after 4-week intervention
measure: Change in serum creatinine
timeFrame: difference between baseline and after 4-week intervention
measure: Change in C-reactive protein (CRP)
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker IL-6 analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker IL-8 analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker IL-10 analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory markers IL-12 analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory markerIL-17a analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker IL-22 analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker IL-23 analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker TNF-alpha analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in inflammatory marker Interferon(IFN)-gamma analysed by an ELISA kit
timeFrame: difference between baseline and after 4-week intervention
measure: Change in oxidative stress measured by free thiols
timeFrame: difference between baseline and after 4-week intervention
Other outcomes:
measure: Difference in change in fecal calprotectin between patients with CD and UC
timeFrame: difference between baseline and after 4-week intervention
measure: Appreciation of WholeFiberTM evaluated by patients with CD and UC?
timeFrame: after 4-week intervention
measure: The convenience of the use of WholeFiberTM evaluated by patients with CD and UC?
timeFrame: after 4-week intervention
measure: The palatability of the use of WholeFiberTM evaluated by patients with CD and UC?
timeFrame: after 4-week intervention
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: Puhlmann ML, de Vos WM. Back to the Roots: Revisiting the Use of the Fiber-Rich Cichorium intybusL. Taproots. Adv Nutr. 2020 Jul 1;11(4):878-889. doi: 10.1093/advances/nmaa025.
citation: Peters V, Dijkstra G, Campmans-Kuijpers MJE. Are all dietary fibers equal for patients with inflammatory bowel disease? A systematic review of randomized controlled trials. Nutr Rev. 2022 Apr 8;80(5):1179-1193. doi: 10.1093/nutrit/nuab062.
citation: Puhlmann ML, de Vos WM. Intrinsic dietary fibers and the gut microbiome: Rediscovering the benefits of the plant cell matrix for human health. Front Immunol. 2022 Aug 18;13:954845. doi: 10.3389/fimmu.2022.954845. eCollection 2022.