Status:
UNKNOWN
The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory Bowel Disease
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Medical Center Haaglanden
Voeding Leeft
Conditions:
Inflammatory Bowel Diseases
Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
- History of prior bariatric surgery or upper gastrointestinal surgery such as Roux-Y reconstruction or (partial) gastrectomy due to benign or malignant pathologies
- Pregnancy or active breastfeeding
- Unwillingness to follow the lifestyle program, i.e. people that do not want to eat fish, vegans
- Any change in IBD-related systemic medication within the last three months of intervention. Changes in medication dose are allowed up to 1 month before the start of the intervention. Exception: changing the route of administration (e.g., switching from intravenous infliximab to subcutaneous infliximab) or change in therapy due to side effects such as an allergic reaction or cutaneous conditions.
- Recent major surgery, e.g. laparotomy in the last four weeks
- Extended hospitalization (a \>2-week admission) within four weeks before inclusion
- Unable to speak and understand Dutch language
- Participation in another study with lifestyle intervention or active consultation with a lifestyle coach on patient's initiative
- Previous participation in the IBD-tailored program by Voeding Leeft
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05374967
Start Date
May 12 2022
End Date
April 1 2024
Last Update
August 1 2023
Active Locations (1)
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1
Leiden University Medical Center (LUMC)
Leiden, Netherlands, 2333ZA