A multicenter study to evaluate the efficacy and safety of Infliximab and Lactobacillus gasseri KBL697 in subjects with moderate to severe active ulcerative colitis patients.
- Conditions
- Diseases of the digestive system
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 80
1) Patients who have the ability to understand and sign written consent to be obtained prior to the commencement of the test procedure, and who are able to comply with the requirements of the human application test.
2) Men or women under the age of 19-75
3) A person diagnosed with moderate and severe ulcerative colitis (a total score of 6 to 12 points of Mayo Clinic Score (MCS), with at least 1 point of bowel movement, 1 point of rectal bleeding, 2 or more points of endoscopy, 2 or more points of doctor's opinion)
4) A person who is clinically deemed to need to be administered biological agents due to a lack of effectiveness in existing treatments;
5) Patients who have no previous experience in using biological agents (IFX, Adalimumab, etc.) as a treatment for ulcerative colitis and who are subject to infleximab administration indications.
6) Patients with oral administration of the following drugs for the purpose of maintaining the baseline criteria:
(1) Oral 5-Aminosalicylic acid (5-Aminosalicylic acid, 5-ASA) compound, Azatioprine (AZA), 6-mergaptopurine (6-Mercaptopurine, 6-MP), or metro-tracet (Metroxate) randomization (MetroxT) for more than four weeks before the baseline.
(2) A person who uses oral corticosteroid therapy (less than 30 mg/day of Prednisone and less than 9 mg/day of Budhesonide) for at least two weeks prior to the baseline and must be stable for 14 weeks after random assignment.
(However, steroids can be reduced by 5 mg per week until 10 mg/day, and 2.5 mg per week from 10 mg/day when clinical symptoms are improved or related based on Prednisolone under judge by principle investigator.)
7) A person who meets the following test values in a laboratory test:
(1) Liver Panel (AST, ALT, Total bilirubin) = 2 × ULN
(2) Estimated CrCl = 40 ml/min calculated by CC&G equation
(3) Blood pigment = 8 g/dL, platelet = 100 × 10^9/L
(4) Absolute Neutral Count (ANC) = 1.5 × 10^9/L (1500/mm^3)
(5) White Blood Cell (WBC) L 3.0 x 10^9/L) Absolute Limphocyte Count (ALC) > 750/mm^3
1) Patients suspected of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, colitis related to diverticular diseases, and microscopic colitis.
2) When acute severe ulcerative colitis is expressed;
(at least six blood stools a day and at least one of the following is body temperature 38 oC (100.4oF) or pulse 90 times/min or higher)
3) Patients who have had a intestinal surgery in the past or who are expected to need a intestinal surgery during the human application test period.
4) Patients with active tuberculosis lesions observed on chest X-rays (However, latent tuberculosis can participate in the study with the approval of the client.)
5) Patients with local medicine (workplace) within two weeks of screening
6) Patients whose fecal samples identify their fungi and pathogen toxins
- pathogenic Escherichia coli (E. coli), Salmonella spp, Shigella spp, Yesinia spp.
- Clostridium difficile (C. difficile) toxin A, B
(However, patients with strains and pathogens toxins can participate after treatment.)
7) Positive patients (but only at the discretion of the tester) in the ova and parasites test (O&P).)
8) Patients with a history of treating lymphocyte depletion therapy, such as Alemtozumab, cyclophosphamide, electrophoresis irradiation, and retoximab.
9) A person who has an overreaction history to IFX, its metabolites or its dosage form.
10) Patients with a history of major surgery or trauma within four weeks prior to screening
11) Patients with cancer history within five years prior to screening (except for non-black skin cancer or cervical epithelial cancer).)
12) Patients with a history of multiple myeloma or lymphoma
13) HIV-positive patients
14) Patients with hepatitis B or C and patients with liver failure
15) Patients who received the following medication before screening
(1) Patients who received oral anti-inflammatory drugs within two weeks prior to screening
(2) Patients who received intravenous anti-inflammatory drugs within four weeks prior to screening
(3) Patients who received a live vaccine within four weeks prior to screening
16) A person who has received other human-applied test foods within 30 days before taking human-applied test foods or has used human-applied test foods and clinical trial medicines;
17) Patients with a history of drug or alcohol abuse
18) Women who are pregnant or breast-feeding, men who plan to donate sperm within six weeks of the completion of the human application test, or women who are willing to donate eggs.
19) Men and women who are not willing to use proper contraception* during the human body application test period.
*Hormon contraceptives, intrauterine devices or intrauterine system implants, double-blocking (both male condoms and closed caps (both contraceptive septum or cervical caps)), infertility procedures (correctomy, bifurcation of both sides, etc.)
20) Patients who are deemed unfit by the investigator to participate in the human application study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the remission ratio based on the MCS in visit 5(14th week) compared to the baseline.
- Secondary Outcome Measures
Name Time Method Evaluate the steroid-free remission ratio in visit 5(14th week) compared to the baseline.;Evaluate the clinical ratio of biopsy, bleeding, defecation in visit 5(14th week) compared to the baseline.;Evaluate the patients ratio with subscore 0 on endoscopy test in visit 5(14th week) compared to the baseline.;Evaluate the change of cytokines and immunological biomarker in blood serum in visit 5(14th week) compared to the baseline.;Evaluate the change of bacterial flora of intestine in visit 5(14th week) compared to the baseline.;Evaluate the change rate of CRP every visit.;Evaluate the change rate of calprotectin in visit 5(14th week) compared to screening.;Evaluate the change of average of short IBDQ score in visit 5(14th week) compared to baseline.