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The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory Bowel Disease | Clinical Trials | Clareo Health

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The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory Bowel Disease

NCT05374967•Leiden University Medical Center

View on ClinicalTrials.gov

Summary

Chronic fatigue is highly prevalent in patients with conditions characterized by chronic inflammation of the gastrointestinal tract, also known as Inflammatory Bowel Disease (IBD). Chronic fatigue has multiple causes, including alterations in immune system or gut microbiota, psychological factors, and sleeping problems. Unsurprisingly, fatigue has been associated with decreased quality of life, general well-being, and work productivity. Very few patients experience resolution in fatigue, emphasizing the need for new therapies. It has been shown that lifestyle interventions can improve most of fatigue-driving factors. Hence, the investigators hypothesize that a multimodal lifestyle intervention focusing on nutrition, sleep, stress, and exercise will improve chronic fatigue in patients with IBD. During this multicenter, controlled trial, the investigators will compare a multimodal lifestyle intervention to a standard therapy (i.e., an informational brochure on how to cope with chronic fatigue).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults (≥18 years old)
•Established IBD diagnosis (Crohn's disease, Ulcerative colitis, or IBD-unclassified)
•Biochemical remission (fecal calprotectin ≤150 mcg/g)
•Clinically significant fatigue (visual analog score 4-8 out of 10)
•Willing and able to attend digital group sessions as a part of the intervention

Exclusion Criteria

•Documented comorbidities such as severe cardiac failure (classified as NYHA 3-4), chronic kidney disease, myelodysplastic syndrome, Chronic Obstructive Pulmonary Disease (COPD), inherited metabolic diseases (e.g., phenylketonuria, mitochondrial or uric acid cycle pathologies), diabetes type 1
•Documented history of malignancy within the last three years before inclusion except for dermatological cancers such as basal cell carcinoma or squamous cell carcinoma
•Documented history of psychiatric diseases, eating disorders, or addiction. Exception: patients with a history of depression and/or under treatment with antidepressants; however, at inclusion the patients must have a Hospital Anxiety Depression Scale (HADS) score \<11 for the depression subscale
•Documented familial hypercholesterolemia
•Diabetes type 2 treated with insulin or other medications such as sulfonylureas, glinides, alpha-glucosidase inhibitors, etc. The only exception is biguanides-metformin
•BMI \<18.5 or \>35 kg/m2
•Clinically significant anemia (Hb \<7.0 mmol/l in females, Hb \<8.0 mmol/l in males) with the exception of marginal normocytic or macrocytic anemia (MCV \>100 fL and Hb \>7.0 mmol/L for females and Hb \>8.0 mmol/L for males) as a result of IBD-therapy related myelosuppression
•Vitamin B12 or folic acid deficiency
•Iron deficiency (defined as ferritin \<30 μg/l)
•Vitamin D deficiency (\<30 nmol/l)
+9 more criteria

Locations (1)

Leiden University Medical Center (LUMC)

Leiden, Netherlands

Key Dates

Start Date

May 12, 2022

Primary Completion Date

March 1, 2024

Completion Date

April 1, 2024

Last Updated

August 1, 2023

Enrollment

ACTUAL participants

Conditions

Inflammatory Bowel DiseasesFatigue

Interventions

Lifestyle intervention: Live with IBD

BEHAVIORAL

Control group

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory Bowel Disease

Inclusion Criteria

Exclusion Criteria

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