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Clinical Trials/NL-OMON54056
NL-OMON54056
Recruiting
Not Applicable

The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients with Inflammatory Bowel Disease - Multi-IBD

eids Universitair Medisch Centrum0 sites106 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
eids Universitair Medisch Centrum
Enrollment
106
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • o Adults (\>\=18 years old);
  • o Established IBD diagnosis (Crohn\*s disease, Ulcerative colitis, or
  • IBD\-unclassified);
  • o Biochemical remission (fecal calprotectin \<\=150 mcg/g);
  • o Clinically significant fatigue (VAS 4\-8 out of 10\);
  • o Willing and able to attend digital group sessions as a part of the
  • intervention.

Exclusion Criteria

  • o 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;
  • o Documented history of malignancy within the last three years before inclusion
  • except for dermatological cancers such as basal cell carcinoma or squamous cell
  • o 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 these patients must have a Hospital
  • Anxiety Depression Scale (HADS) score \<11 for the depression subscale;

Outcomes

Primary Outcomes

Not specified

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