UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050892 |
|---|---|
| Receipt number | R000057979 |
| Scientific Title | Effects of symbiotics on diarrhea after gastrectomy: an interventional study |
| Date of disclosure of the study information | 2023/06/15 |
| Last modified on | 2023/04/19 21:57:22 |
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Basic information
Public title
Effects of symbiotics on diarrhea after gastrectomy: an interventional study
Acronym
Effects of symbiotics on diarrhea after gastrectomy: an interventional study
Scientific Title
Effects of symbiotics on diarrhea after gastrectomy: an interventional study
Scientific Title:Acronym
Effects of symbiotics on diarrhea after gastrectomy: an interventional study
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of synbiotics on diarrhea symptoms in patients after gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in GSRS diarrhea symptom subscale scores before and after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of Super Symbiotic LBG-P (3.0 g/day of live lactic acid bacteria and bifidobacteria, 20.4 g/day of oligosaccharides) for 28 days
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)20 to 85 years of age
(2)Histologically diagnosed as gastric cancer
(3)Gastrectomy (excluding partial gastrectomy) with R0 resection
(4)Pathological Stage I, II, or III
(5)More than 6 months have passed since surgery
(6)No recurrence
(7)Performance status less than 2
(8)Organ function (laboratory tests): satisfy all of the following
(i) White blood cell count: more than 2,000/mm3
(ii) Hemoglobin: more than 8.0 g/dL
(iii) Platelet count: more than 50000/ mm3
(iv) Total bilirubin: less than 3 mg/dL
(v) AST: less than 100 U/L
(vi) ALT: less than 100 U/L
(vii) Serum creatinine: less than 2.0 mg/dL
(9) Consent for participation in the study has been obtained from the subject.
Key exclusion criteria
(1)GSRS diarrhea symptom subscale score of 3 or less
(2)Patients with the following history or treatment: esophagectomy, gastrointestinal bypass, massive small bowel resection, pancreaticoduodenectomy, prior chemotherapy within 6 months, prior radiation therapy within 6 months
(3)Patients with the following comorbidities: inflammatory bowel disease, colostomy, liver cirrhosis, renal failure requiring dialysis
(4)Patients under the following treatment: laxatives, antibiotics
(5)Patients with milk allergy
(6)Foreigners
(7) Patients who have expressed their refusal to participate in the study
(8)Other patients whom the physician deems inappropriate to participate in the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Obama |
Organization
Kyoto University Hospital
Division name
Department of Surgery
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
kobama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Fujita |
Organization
Kyoto University Hospital
Division name
Department of Surgery
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
yusuke0424@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Yakult Bio-Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 15 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057979
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| Registered date | File name |
| Research case data | |
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