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A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease

NCT05906043 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-06-22

No results posted yet for this study

Summary

This study is examining fatigue in patients with Inflammatory Bowel Disease (IBD). IBD includes Ulcerative Colitis (UC) and Crohn's disease. These are inflammatory conditions of the gastrointestinal tract and are associated with symptoms including diarrhoea, rectal bleeding and abdominal pain. Fatigue is a common problem for patents with IBD, affecting 80% of patients with active disease.This study aims to identify all IBD patients with fatigue. Initially, the investigators will address all medical causes of fatigue in line with current practice, using a stepwise approach (e.g. assessing for and treating active inflammation, anaemia as well as electrolyte, hormone and vitamin imbalances). The aim is to treat fatigue using a detailed algorithm, as fatigue is often a consequence of multiple issues in IBD patients. The investigators will assess the role of physical activity, nutritional status and psychological wellbeing in fatigue persisting in medically-optimised IBD patients. In addition, the contribution of the microbiome to fatigue will be assessed. For those in whom these factors are identified alongside persistent fatigue, interventions have been designed to address these factors and the resulting fatigue.

Conditions

  • Inflammatory Bowel Diseases
  • Fatigue

Interventions

BEHAVIORAL

Exercise Intervention

Exercise intervention

BEHAVIORAL

Acceptance and Commitment Therapy

ACT will be used for patients with psychological disability as well as for those with sleep disturbance

DIETARY_SUPPLEMENT

Probiotic

Use of a probiotic

Sponsors & Collaborators

  • University College Dublin

    lead OTHER

Principal Investigators

  • Hugh Mulcahy, MD FRCPI · St Vincent's University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-20
Primary Completion
2025-06-24
Completion
2025-08-24

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906043 on ClinicalTrials.gov