UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060810 |
|---|---|
| Receipt number | R000069578 |
| Scientific Title | A Clinical Trial of Saireito for the Prevention of High-Output Stoma in Patients with Temporary Ileostomy after Surgery for Ulcerative Colitis |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/03/03 16:49:18 |
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Basic information
Public title
A Clinical Trial of Saireito for the Prevention of High-Output Stoma in Patients with Temporary Ileostomy after Surgery for Ulcerative Colitis
Acronym
A Clinical Trial of Saireito for the Prevention of High-Output Stoma in Patients with Temporary Ileostomy after Surgery for Ulcerative Colitis
Scientific Title
A Clinical Trial of Saireito for the Prevention of High-Output Stoma in Patients with Temporary Ileostomy after Surgery for Ulcerative Colitis
Scientific Title:Acronym
SAILOR(SAIreito for ILeostomy Output Reduction) study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether postoperative administration of Saireito (TJ-114) reduces the incidence of high-output stoma (HOS) in patients who undergo surgery for ulcerative colitis with the creation of a temporary ileostomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of early high-output stoma (HOS) within 21 days after surgery.
Early HOS is defined as a stoma output of >1,500 mL/day for three consecutive days within 21 days postoperatively.
Stoma output will be measured daily during hospitalization based on nursing records and electronic medical records.
Key secondary outcomes
Length of hospital stay
Incidence of >20% decline in eGFR at 1 month postoperatively and immediately before stoma closure, compared with preoperative baseline
Requirement for unplanned intravenous fluid administration within 21 days after surgery
Readmission within 21 days after surgery
Incidence of adverse events assessed according to CTCAE version 5.0
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Saireito (Tsumura Saireito Extract Granules, TJ-114) will be administered orally at a dose of 9 g/day (3 g three times daily after meals) from postoperative day 2 (POD2) for 14 consecutive days.
Concomitant use of other Kampo (traditional Japanese herbal) medicines will be prohibited during the intervention period.
Standard perioperative management, including fluid therapy, dietary guidance, and antidiarrheal agents, will be provided according to institutional practice.
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 diagnosed with ulcerative colitis (UC) undergoing total proctocolectomy (two- or three-stage surgery) with creation of a temporary ileostomy
Age >=18 years at the time of informed consent
Patients considered capable of oral intake according to the postoperative management protocol
Patients who have provided written informed consent to participate in the study
Key exclusion criteria
History of hypersensitivity to Kampo medicines
Patients judged to be unable to receive oral medication in the early postoperative period
Severe hepatic dysfunction, severe heart failure, or other conditions judged inappropriate by the principal investigator
Pregnant or breastfeeding women, or women who may be pregnant
Any other condition deemed inappropriate for participation by the investigator
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Mitsuro |
| Middle name | |
| Last name | Kanda |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Gastroenterological Surgery, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442250
sato.yusuke.a3@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sato |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Gastroenterological Surgery, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442250
Homepage URL
sato.yusuke.a3@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Certified Review Board
Address
Tsurumai-cho 65, Showa-ku, Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069578
