Primary Objective: To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels in patients with CD and UC.Secondary Objective(s):- To explore the effect of a 4-week WholeFiberTM intervention on stool pattern…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on
fecal calprotectin levels in patients with CD and UC.
Secondary outcome
Secondary Objective(s):
- To explore the effect of a 4-week WholeFiberTM intervention on stool pattern,
IBD-complaints and QoL in patients with CD and UC.
- To explore the effect of a 4-week WholeFiberTM intervention on fecal
microbiota composition, SCFA levels, fecal pH and redox status in patients with
CD and UC.
- To explore the effect of a 4-week WholeFiberTM intervention on serum markers
in IBD in patients with CD and UC.
- How is the use of WholeFiberTM evaluated by patients with CD and UC?
- Is there a difference in effect of WholeFiberTM between patients with CD and
UC?
Background summary
Dietary fiber intake is usually lower than recommended and dried vegeltable can
be a useful additional source. This may inprove the gut microbiome, increase
SCFA production and reduce inflammation
Study objective
Primary Objective:
To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on
fecal calprotectin levels in patients with CD and UC.
Secondary Objective(s):
- To explore the effect of a 4-week WholeFiberTM intervention on stool pattern,
IBD-complaints and QoL in patients with CD and UC.
- To explore the effect of a 4-week WholeFiberTM intervention on fecal
microbiota composition, SCFA levels, fecal pH and redox status in patients with
CD and UC.
- To explore the effect of a 4-week WholeFiberTM intervention on serum markers
in IBD in patients with CD and UC.
- How is the use of WholeFiberTM evaluated by patients with CD and UC?
- Is there a difference in effect of WholeFiberTM between patients with CD and
UC?
Study design
This is a 4-week before-after pilot study to explore the effectiveness of a
WholeFiberTM 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.
Since a sudden increase in dietary fiber can cause some changes in GI-related
sensations, such as bloating, flatulence, belching and nausea (Reynolds et al.,
2020), fiber intake will be gradually increased in this trial. First, subjects
will receive 10 g/day of WholeFiberTM (~8.5 g/day of fiber) for the first 2
weeks, after which they will increase the dose to 2x 10 g/day of WholeFiberTM
(~17 g/day of fiber) for the last two weeks. y.
There are three timepoints included in this study:
- At the start (baseline), where patients will take a fecal sample, a blood
sample will be drawn and patients will fill in questionnaires.
- Halfway (after 2 weeks), patients will fill in online questionnaires at home.
- At the end (after 4 weeks), patients will take a fecal sample, a blood sample
will be drawn and patients will fill in questionnaires.
Intervention
Terwijl patiënten hun gebruikelijke voeding blijven eten krijgen ze in de
eerste 2 weken van de interventie 10 gram Whole Fibre per dag. In de derde en
vierde week is dit 20 gram Whole Fibre per dag.
While patients keep following their habitual dietary intake, they will consume
10 gram of Whole Fiber during the first two weeks and 20 gram of Whole Fibre
during week 3 and 4.
Study burden and risks
The intervention is therapeutic for the paticipants. The risj associated with
the particpation is neglible and the burden can be considered as minimal.
During both visits:
3 tube of bood will be drawn (28 ml per time: totaal 56 ml during the complete
study)
Participants will be asked to consume extra 10 gram of Whole fibre during the
first 2 weeks; during week 3 and week 4 they will be asked to consume 20 gram
Whole Fibre (a vegetable fibre)
3 times they will be asked to complete questionnaires, which will not cause
psychological damage. The following questionnaires will be used:Er wordt HBI or
SSCAI vragenlijst, FrQOL, Bristol stool chart)
They will be asked to fill out a 3 day food diary twice.
Twice fecal samples will be collected, which will be collected from their home
Total length of the study for a participant is 4 weeks, total time involved is
3.5 hours
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Men and women aged >=18 years;
- Having a diagnosis of IBD (either UC or CD) and undergoing treatment at the
outpatient at UMCG;
- Mild or moderate IBD, defined as fecal calprotectin levels >=100 µg/ gram
faeces and Harvey Bradshaw Index (HBI) <8 for CD patients or Simple Clinical
Colitis Activity Index (SCCAI) <5 for CU patients;
- Using stable maintenance therapy for at least 12 weeks;
- Being able to read and speak Dutch;
- Willing to come to the UMCG 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 synbiotics (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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06016322 |
| CCMO | NL85061.042.23 |