The Effect of Citrus Extract on Gastrointestinal Health

Irritable Bowel Syndrome Clinical Trial

Official title:

The Effect of Citrus Extract Administration on Gastrointestinal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225261
• Other study ID #: 173003
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2017
• Est. completion date: February 13, 2021

Study information

• Verified date: February 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 13, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Citrus extract
Citrus extract
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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