To evaluate the effect of dietary therapy with a probiotic supplement on the composition of stool microbiome in fatigued IBD patients with quiescent diseaseTo define the effect of dietary therapy with a probiotic supplement on serum inflammatory…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in fatigue symptoms after probiotic supplement
Secondary outcome
1. The feasibility of probiotic therapy in IBD patients
2. Changes in composition of stool microbiome, serum inflammatory cytokines and
metabolomic profiles after probiotic supplement
3.Changes in subjective symptoms like depression, anxiety and sleep after
probiotic supplement
Background summary
Nearly 48% of patients with quiescent inflammatory bowel diseases (IBD) suffer
from severe fatigue which negatively impacts health-related quality of life.
The mechanisms underlying fatigue in this population are poorly understood,
limiting our ability to provide effective interventions. Existing therapies
focusing on cognitive behavioral therapy have not been effective. Emerging
research supports a role for the gut microbiome in mediating fatigue through
several mechanisms including altered metabolism and the gut-brain axis. No
prior studies have examined this in patients with IBD. Identification of a role
for the microbiome in fatigue in IBD will offer new treatment targets to
relieve fatigue.
The objective of the proposed project is to examine the role of the gut
microbiome in mediating fatigue in IBD through a prospective interventional
treatment study.
Study objective
To evaluate the effect of dietary therapy with a probiotic supplement on the
composition of stool microbiome in fatigued IBD patients with quiescent disease
To define the effect of dietary therapy with a probiotic supplement on serum
inflammatory cytokines level and metabolomic profiles in fatigued IBD patients
with quiescent disease
To assess the efficacy of a probiotic supplement on fatigue symptoms in
patients with quiescent IBD.
Study design
Double blind randomized placebo-controlled clinical trial
Intervention
The study intervention for this clinical trial are probiotic supplements or
placebo. Both the probiotic supplement and identical placebo. The probiotic
supplements contains 9 different strains of bacteria and will be dosed in two
dosages per a total of 40 billion bacteria daily for 12 weeks.The probiotic
supplement is powder which can be diluted in some lukewarm water.
Study burden and risks
They study entails 4 study visits and 1 phone call which will be tried to
combine with their routine clinical visits. During these visits, the subject
will fill in questionnaires. We do not anticipate any psychosocial risks. At
start and at the end of the study, the subject will be asked for a blood and
stool sample.
The knowledge gained from this proposal will provide critical insight into
effect of probiotic supplements on subjective symptoms, serum cytokine and
metabolomic profiles, and the gut microbiome in patients with quiescent IBD.
Our findings will significantly advance efforts towards identification of safe
and effective therapies for fatigue in IBD.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
* Age 18-75 years
* Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria
* Quiescent disease defined as HBI * 4 for CD and SCCAI * 2 for UC
* Persistent ongoing fatigue symptoms, defined as FACIT-F < 43
* Normal fecal calprotectin (< 250ug/g) and C-reactive protein (< 8mg/L) within 12 months of screening
* Endoscopic or radiologic remission within 12 months of screening
Exclusion criteria
* Patients with clinical or endoscopically active inflammatory bowel disease
* Significant non-IBD comorbidity contributing to the fatigue (such as active cancer).
* Untreated severe depression or anxiety
* Known sleep disorders without adequate treatment,
* Concurrent use of narcotics or long-term oral antibiotic therapy
* Severe vitamin D deficiency (< 10 ng/mL)
* J-pouch or a stoma
* Ongoing use of other non-study probiotics
* Women who are pregnant or lactating
Design
Recruitment
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 | NCT03266484 |
| CCMO | NL65206.078.18 |