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OpenTrials
Completed

NCT Number: NCT04191707

Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Fatigue is a common symptom and a leading concern in patients with inflammatory bowel disease (IBD) and often persists despite clinical and endoscopic remission.

This study evaluates the metabolomic profile of fatigued patients with IBD.

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Key information

About this study

To date, there is only one non-published study using metabolomics in quiescent IBD patients with and without fatigue.

The investogators designed this study to examine if there are metabolomics factors associated to fatigue in IBD patients.

This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent. (1) IBD outpatients attending the Hospital de Sabadell Gastroenterology Day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion.

The investigators recorded demographic data, IBD classification according to the Montreal classification, and history of drug administration. In addition, clinical activity of the disease was measured using the Harvey-Bradshaw score for Crohn's disease (CD) and the modified Mayo score for ulcerative colitis (UC). The "Functional Assessment of chronic Illness Therapy-Fatigue" (FACIT-F) was used to assess fatigue.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) .

Exclusion criteria

  • Age below 18 years.
  • Refusal to give written informed consent prior to participation
  • Active infection at the time of inclusion.
  • Concomitant diseases not related to IBD (e.g., cancer, heart disease, pulmonary disease) that might contribute to the presence or the severity of fatigue.
  • Active flare of IBD in the last 3 months.

Treatment and study plan

Primary outcomes

  1. changes in metabolomic profile

    Time frame: 1 year

    The metabolic profile consisted in 75 metabolites that were measured

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2019
Registry last updated
Dec 10, 2019

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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