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Completed

NCT Number: NCT03225261

The Effect of Citrus Extract on Gastrointestinal Health

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

citrus extract

Dietary Supplement

Citrus extract

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. The effect on intestinal inflammation, measured by fecal calprotectin levels.

    Time frame: 8 weeks

    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 outcomes

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

  6. The effect on disease symptoms, measured by patient reported outcomes (symptom diary).

    Time frame: 8 weeks

  7. The effect on stool frequency, measured by Bristol Stool Chart.

    Time frame: 8 weeks

  8. The effect on stool consistency, measured by Bristol Stool Chart.

    Time frame: 8 weeks

  9. The effect on blood markers for oxidative stress, measured by MDA concentration in blood.

    Time frame: 8 weeks

  10. The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Citrus Extract Administration on Gastrointestinal Health

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2017
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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