NCT05906043

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

Status unknown NA Last updated 22 June 2023

What this trial tests

NA trial testing Exercise Intervention in Inflammatory Bowel Diseases in 250 participants. Status unknown.

Timeline

20 June 2023

Primary endpoint
24 June 2025

24 August 2025

Quick facts

Lead sponsor	University College Dublin
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	20 June 2023
Primary completion	24 June 2025
Estimated completion	24 August 2025
Sites	1 location across Ireland

Drugs / interventions tested

• Exercise Intervention
• Acceptance and Commitment Therapy
• Probiotic

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Fatigue — all drugs for Fatigue →

Sponsor

University College Dublin

Who can join

Adults 18 to 70, any sex, with Inflammatory Bowel Diseases or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineered Probiotic-Based Biomaterials for Inflammatory Bowel Disease Treatment.
   Sang G, Wang B, Xie Y, Chen Y, et al · · 2025 · cited 9× · PMID 40093907 · DOI 10.7150/thno.103983
2. Targeting the Intestinal Microbiota: A Novel Direction in the Treatment of Inflammatory Bowel Disease.
   Zhang J, Gan H, Duan X, Li G. · · 2024 · cited 4× · PMID 39457652 · DOI 10.3390/biomedicines12102340
3. Application of acceptance and commitment therapy in cancer-related fatigue management: insights from clinical trials and future perspectives.
   Chen X, Li Z. · · 2025 · cited 1× · PMID 39964319 · DOI 10.1097/js9.0000000000002305