NCT03225261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

June 9, 2017

Last Update Submit

February 18, 2021

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).

    8 weeks

  • The effect on fecal microbiota composition, assessed by next generation sequencing.

    8 weeks

  • The effect on fecal microbiota functional capacity, assessed by next generation sequencing.

    8 weeks

  • The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood

    8 weeks

  • The effect on disease symptoms, measured by patient reported outcomes (GSRS).

    8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Citrus extract

EXPERIMENTAL

Citrus extract

Dietary Supplement: Citrus extract

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Citrus extractDIETARY_SUPPLEMENT

Citrus extract

Citrus extract
PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with IBS
  • Calprotectin levels 15-150 µg/g feces
  • Age 18-70 years
  • BMI \< 35 kg/m2

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

grapefruit seed extract

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ad Masclee, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc.

Study Record Dates

First Submitted

June 9, 2017

First Posted

July 21, 2017

Study Start

November 20, 2017

Primary Completion

February 12, 2021

Study Completion

February 13, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)