Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Metabolomic Markers of Fatigue in Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04191707
• Other study ID #: 2014068
• Status: Completed
• Start date: November 1, 2013
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Fatigue
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

References & Publications (1)

Villoria A, García V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramírez-Lázaro 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in metabolomic profile	The metabolic profile consisted in 75 metabolites that were measured	1 year