Efficacy of elemental diet, Elental on maintenance therapy of Crohn's disease after remission with anti-TNFa antibody.(non-randomized control study)

Efficacy of elemental diet, Elental on maintenance therapy of Crohn's disease after remission with anti-TNFa antibody.(non-randomized control study) - Additional Power of Elemental Diet (Elental)on Maintenance Biologics therapy in Crohn's Disease. (ADORE Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009789

Enrollment

100

Registered

2013-01-16

Start date

2010-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

Patients take &gt

=900 kcal/day elemental diet, combination with scheduled biologics treatment. Patients dose not use any enteral diet therapy, combination with scheduled biologics treatment.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderate to severe (CDAI 220-400) patients. Patients who are introduced anti-TNFa antibody as induction therapy. Patients approving the study consent.

Exclusion criteria

Exclusion criteria: Patients in 16 weeks after last biologics dosing or after bowel resection. Patients with stoma. Parenteral nutrition dependent patients with short bowel syndrome or others. Biologics intolerance. Patients judged as inadequate at the discretion of physicians.

Design outcomes

Primary

Measure	Time frame
The occurrence of relapse (Relapse was defined by: (1) increase in CDAI of at least 70 points from the baseline score with a total score of at least 220, (2) shortening of biologics dosing interval (3) introduction of a new treatment for active Crohn's disease)	—

Secondary

Measure	Time frame
Response rate, safety assesment Others	—

Countries

Japan

Contacts

Public ContactFumihito Hirai

Fukuoka University Chikushi Hospital Depertment of Gastroenterology

syokaki@fukuoka-u.ac.jp092-921-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Efficacy of elemental diet, Elental on maintenance therapy of Crohn&#39;s disease after remission with anti-TNFa antibody.(non-randomized control study)