The Effect of Citrus Extract Administration on Gastrointestinal Health

Maastricht University Medical Center1 site in 1 country29 target enrollmentNovember 20, 2017

ConditionsIrritable Bowel Syndrome

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Irritable Bowel Syndrome
Sponsor: Maastricht University Medical Center
Enrollment: 29
Locations: 1
Primary Endpoint: The effect on intestinal inflammation, measured by fecal calprotectin levels.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 20, 2017

End Date

February 13, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Principal Investigator

Yala Stevens

MSc.

Maastricht University Medical Center

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

Outcomes

Primary Outcomes

The effect on intestinal inflammation, measured by fecal calprotectin levels.

Time Frame: 8 weeks

The primary objective is to assess the effect of 500 mg citrus extract on intestinal flammation after 8 weeks of administration, by measuring fecal calprotectin in IBS patients with moderately increased fecal calprotectin levels.

Secondary Outcomes

The effect on disease symptoms, measured by patient reported outcomes (GSRS).(8 weeks)
The effect on fecal microbiota composition, assessed by next generation sequencing.(8 weeks)
The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.(8 weeks)
The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).(8 weeks)
The effect on fecal microbiota functional capacity, assessed by next generation sequencing.(8 weeks)
The effect on disease symptoms, measured by patient reported outcomes (symptom diary).(8 weeks)
The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood(8 weeks)
The effect on stool frequency, measured by Bristol Stool Chart.(8 weeks)
The effect on blood markers for oxidative stress, measured by MDA concentration in blood.(8 weeks)
The effect on stool consistency, measured by Bristol Stool Chart.(8 weeks)