The Effect of Citrus Extract on Gastrointestinal Health

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Citrus extract

• Registration Number: NCT03225261
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-11-20
• Status Verified: 2021-02
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-13
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin
Citrus extract	Citrus extract	Citrus extract

Primary Outcome Measures

Name	Time	Method
The effect on intestinal inflammation, measured by fecal calprotectin levels.	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 Outcome Measures

Name	Time	Method
The effect on fecal microbiota composition, assessed by next generation sequencing.	8 weeks
The effect on disease symptoms, measured by patient reported outcomes (GSRS).	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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands