Clinical trial NCT03225261: The Effect of Citrus Extract on Gastrointestinal Health
Official title: The Effect of Citrus Extract Administration on Gastrointestinal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with IBS
* Calprotectin levels 15-150 µg/g feces
* Age 18-70 years
* BMI \< 35 kg/m2

Exclusion Criteria:

* Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator)
* Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator)
* Use of immunosuppressive drugs within 3 months before study period
* Use of other medication interfering with endpoints
* Changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study
* Changes in clinical activity scores within 3 weeks prior to the study
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
* Use of dietary supplements containing antioxidants, minerals and vitamins
* Excessive intake of foods with a high polyphenol concentration
* Use of antibiotics within 3 months prior to the start of study
* Use of pre-or probiotics within 1 month prior to the study
* Use of oral corticosteroids within 1 month prior to the study
* Blood donation within 1 month prior to the study
* Known pregnancy or lactation.
* Excessive drinking (\>20 alcoholic consumptions per week)
* History of any side effects towards the intake of flavonoids or citrus fruits

Primary outcomes:
measure: The effect on intestinal inflammation, measured by fecal calprotectin levels.
timeFrame: 8 weeks
Secondary outcomes:
measure: The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).
timeFrame: 8 weeks
measure: The effect on fecal microbiota composition, assessed by next generation sequencing.
timeFrame: 8 weeks
measure: The effect on fecal microbiota functional capacity, assessed by next generation sequencing.
timeFrame: 8 weeks
measure: The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood
timeFrame: 8 weeks
measure: The effect on disease symptoms, measured by patient reported outcomes (GSRS).
timeFrame: 8 weeks
measure: The effect on disease symptoms, measured by patient reported outcomes (symptom diary).
timeFrame: 8 weeks
measure: The effect on stool frequency, measured by Bristol Stool Chart.
timeFrame: 8 weeks
measure: The effect on stool consistency, measured by Bristol Stool Chart.
timeFrame: 8 weeks
measure: The effect on blood markers for oxidative stress, measured by MDA concentration in blood.
timeFrame: 8 weeks
measure: The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ad Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: