chronic bowel inflammation Inflammatory bowel disease
Conditions
Interventions
Group A will receive an over the counter multivitamin and mineral supplement
(New Care Multi®), once daily for the period of 24 weeks.
Group B will be randomized to receive the placebo, identical in
Sponsors
Sint Elisabeth Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients between the ages of 18 and 75 years old; * Patients diagnosed with Crohn*s disease or Ulcerative Colitis; * Patients using immunomodulators and/ or biologic therapy.
Exclusion criteria
Exclusion criteria: - patients with active inflammation; - patients who has undergone surgical resection or are expected to require during the stuy - patients wo are pregnant or planning pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the difference in incidence of infections measured by preformatted questionnaire and clinical data between the multivitamin and mineral and placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study are the differences in quality of live indicated by the Inflammatory Bowel Disease Questionnaire, in fatigue as measured by the Chalder Fatigue Questionnaire, stool frequency and - consistency measured by the Bristol Stool Scale and disease activity measured by standard clinical and laboratory assessments. | — |
Countries
Netherlands
Outcome results
None listed