The effects of citrus extract administration on gastrointestinal health

Completed

• Conditions: irritable bowel syndrome; spastic colon; 10017969

• Registration Number: NL-OMON50647
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 128

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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the evaluation of intestinal<br /><br>inflammation, measured by levels of fecal calprotectin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints entail the evaluation of daily administration of citrus<br /><br>extract on metabolic activity (fecal markers), microbiota composition and<br /><br>functional capacity (fecal markers), immune system performance (blood markers),<br /><br>gastrointestinal symptoms (questionnaires), and oxidative stress markers (blood<br /><br>markers). </p><br>