UMIN-CTR Clinical Trial

Basic information
Public title	A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients
Acronym	A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients
Scientific Title	A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients
Scientific Title:Acronym	A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of antibiotic combination therapy for ulcerative compared with steroid therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Remission rate at 3 months
Key secondary outcomes	Response rate at 3 months, remission and response rate at 12 months

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	14 days oral intake of amoxicillin 1500 mg/day, tetracycline 1500 mg/day and metronidazole 750 mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who has an established diagnosis of UC based on endoscopic, clinical and histological feature
Key exclusion criteria	penicillin allergy, administration of antibiotics agents within 2 weeks of study entry, ongoing biologic therapy, pregnancy, cancer and other serious comorbid illness, having stool pathogens including Clostridium difficile, Salmonellae, pathogenic Escherichia coli, etc
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Toshifumi Middle name Last name Ohkusa
Organization	Juntendo university graduate school of medicine
Division name	Department of Microbiota Research
Zip code	113-0033
Address	Ochanomizu KS building 405, 3-3-1 Hongo Bunkyo-ku, Tokyo
TEL	0338133111
Email	ohkusa@juntendo.ac.jp

Public contact
Name of contact person	1st name Toshifumi Middle name Last name Ohkusa
Organization	Juntendo university graduate school of medicine
Division name	Department of Microbiota Research
Zip code	113-0033
Address	Ochanomizu KS building 405, 3-3-1 Hongo Bunkyo-ku, Tokyo
TEL	0338133111
Homepage URL
Email	ohkusa@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Jukei univeristy
Address	3-25-8 Nishishimbashi
Tel	0334331111
Email	crb@jikei.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	311
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 07 Month 01 Day
Date of IRB	2008 Year 09 Month 08 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 29 Day
Last modified on	2022 Year 07 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055285