Crohn'
Conditions
Interventions
2 packs of Elental administered in addition to the current dose (>
900 kcal/day of the total dose)
Control group (a group of IBD patients whose current dose will be maintained)
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A) Patients aged =>16 years who are definitively diagnosed with CD or UC. B) CD: Patients in the mildly to moderately active stage with a 150 > CDAI < 221.UC: Patients in the mildly to moderately active stage with a 3 > DAI < 11. C) Patients with stable disease and an Alb < 3.8 g/dL. D) Patients who provided written consent to participate in the trial. * In the case of a minor, guardian consent shall be required.
Exclusion criteria
Exclusion criteria: A) Cannot continue receiving Elental (ED-intolerant, severe diabetes, receiving high-dose steroids, suspected of having abnormal glucose or abnormal amino acid metabolism); B) Less than 18 years of age and lacking guardian consent; or C) Judged by the principal investigator as inappropriate subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A) Change in disease score (CDAI for CD; DAI for UC) before versus after the 12 weeks of treatment B) Change in blood amino acid levels before versus after the 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| A) Influences on quality of life B) Changes in immunoregulatory therapy C) Hematological, blood biochemical, and nutritional indices | — |
Countries
Japan
Contacts
Public ContactMasakazu Nakano
Dokkyo Medical University Department of Gastroenterology
Outcome results
None listed