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The Effect of Citrus Extract on Gastrointestinal Health

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Citrus extract
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citrus extract

Placebo

Arm Description

Citrus extract

Maltodextrin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2017
Last Updated
February 18, 2021
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03225261
Brief Title
The Effect of Citrus Extract on Gastrointestinal Health
Official Title
The Effect of Citrus Extract Administration on Gastrointestinal Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
February 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citrus extract
Arm Type
Experimental
Arm Description
Citrus extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Citrus extract
Intervention Description
Citrus extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
The effect on intestinal inflammation, measured by fecal calprotectin levels.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).
Time Frame
8 weeks
Title
The effect on fecal microbiota composition, assessed by next generation sequencing.
Time Frame
8 weeks
Title
The effect on fecal microbiota functional capacity, assessed by next generation sequencing.
Time Frame
8 weeks
Title
The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood
Time Frame
8 weeks
Title
The effect on disease symptoms, measured by patient reported outcomes (GSRS).
Time Frame
8 weeks
Title
The effect on disease symptoms, measured by patient reported outcomes (symptom diary).
Time Frame
8 weeks
Title
The effect on stool frequency, measured by Bristol Stool Chart.
Time Frame
8 weeks
Title
The effect on stool consistency, measured by Bristol Stool Chart.
Time Frame
8 weeks
Title
The effect on blood markers for oxidative stress, measured by MDA concentration in blood.
Time Frame
8 weeks
Title
The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ad Masclee, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Citrus Extract on Gastrointestinal Health

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