The Effect of Citrus Extract on Gastrointestinal Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2021-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults

NCT03749031

Digestive Health

COMPLETED NA

Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery

NCT02716285

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases, Functional

COMPLETED PHASE3

Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire

NCT03824821

Irritable Bowel Syndrome

COMPLETED

Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

NCT04662957

Irritable Bowel Syndrome With Diarrhea Effects of Probiotics

COMPLETED NA

Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Effectiveness Study

NCT05328245

Irritable Bowel Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Citrus extract

Group Type EXPERIMENTAL

Citrus extract

Intervention Type DIETARY_SUPPLEMENT

Citrus extract

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Citrus extract

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No