Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

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

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fatigue Inflammatory Bowel Disease Ulcerative Colitis Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Outpatients with Inflammatory Bowel Disease

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Diana Horta-Sangenis

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana Horta

Role: PRINCIPAL_INVESTIGATOR

Parc Tauli Hospital

References

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Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.

Reference Type BACKGROUND

PMID: 28749985 (View on PubMed)

Other Identifiers

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2014068

Identifier Type: -

Identifier Source: org_study_id