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The Effect of Citrus Extract on Gastrointestinal Health

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status and phase

Completed
Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Citrus extract

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

29 participants in 2 patient groups, including a placebo group

Citrus extract
Experimental group
Description:
Citrus extract
Treatment:
Dietary Supplement: Citrus extract
Placebo
Placebo Comparator group
Description:
Maltodextrin
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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