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Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy

Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy - Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010293
Enrollment
80
Registered
2013-03-21
Start date
2009-12-19
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

Infliximab maintenance therapy for 48 weeks in, Racol daily nutritional interventions during the study period as a target intake of 800kcal per day, in the implementation group nutrition therapy is us

Sponsors

Graduate School of Medical Sciences, Kyushu University
Lead Sponsor
Oita Red Cross Hospital Takano Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with Crohn's disease in remission underwent infliximab maintenance therapy that meets all of the following criteria: It is intended for. (1) Administered every 8 weeks infliximab, the patient is less than or equal to 150 CDAI (2) Patient age at the time of registrationis at least 20 years of age, consent has been obtained for participation in this study

Exclusion criteria

Exclusion criteria: This is true even if one of the following are excluded from the scope. (1)Patients with bowel obstruction (2)Patients with short bowel syndrome (3)Patients with advanced liver and kidney failure (4)Patients with abnormal glucose metabolism, such as severe diabetes (5)Patients with congenital disorders of amino acid metabolism (6)Patients with milk protein allergy (7)Patients with stoma (8) Other patients attending physician has determined inappropriate test

Design outcomes

Primary

MeasureTime frame
Cumulative non-relapse rate at 48 weeks (Definition of relapse; as if CDAI was more than 150 and had increased more than 70 from the previous value. Cases of relapse were defined as patients who fulfill the definition of relapse at least once in determination of CDAI at every four weeks.)

Secondary

MeasureTime frame
1)CRP concentration in Blood 2)QOL assessment by SF-36 Other

Countries

Japan

Contacts

Public ContactKoji Ikegami

Graduate School of Medical Sciences, Kyushu University Medical and Clinical Science

kikegami@intmed2.med.kyushu-u.ac.jp092-642-5261

Outcome results

None listed

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