Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study -

Efficacy of GMA in steroid naive patients with active ulcerative colitis. -a multicenter study - - To evaluate the efficacy of GMA in steroid naive patients with active ulcerative colitis.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000013702

Enrollment

200

Registered

2014-04-13

Start date

2014-04-21

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

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Steroid naive patients. 2. Patients refractory to high dose 5-ASA agents. 3. Antibiotics naive patients. 4. Patients with Mayo score 3 to 10.

Exclusion criteria

Exclusion criteria: 1. Re-registered patients. 2. Patients whose granulocyte count below 2,000/mm3. 3. Patients with or suspected to have severe infection. 4. Patients with serious heart disease. 5. Patients with serious kidney disorder. 6. Patients with hypotension (mamimal blood pressure below 80mmHg). 7. Pregnant patients 8. Patients with serious dehydration, serious coagulation abnormality, or serious anemia (Hb below 8.0d/dL). 9. Patients with malignancy. 10. Patients who have artificial anus. 11. Patients who have undergone intestinal operation within 12 weeks. 12. Patients who have severe extraintestinal complications. 13. Patients who have received an initial dose or an increased dose of 5-ASA agents within 2 weeks before screening. 14. Patients who have received a dose of tacrolimus within 4 weeks before screening. 15. Patients who have received cytapheresis within 4 weeks before screening. 16. Patiens who have received an initial dose or an increased dose of immunomodulators within 8 weeks before screening. 17. Patients who are judged to be ineligible by an investigator.

Design outcomes

Primary

Measure	Time frame
Remission rate	—

Secondary

Measure	Time frame
1.Improvement of endoscopic index. 2.The incidence of adverse events.	—

Countries

Japan

Contacts

Public ContactKazuki Kakimoto

Osaka Medical College Hospital 2nd Department of Internal Medicine

in2098@osaka-med.ac.jp072-683-1221

Outcome results