UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026358 |
|---|---|
| Receipt number | R000030256 |
| Scientific Title | Influence of Lactobacillus salivarius WB21 on small bowel injuries in subjects who take NSAID and PPI; a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/03/31 17:13:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Influence of Lactobacillus salivarius WB21 on small bowel injuries in subjects who take NSAID and PPI; a randomized, double-blind, placebo-controlled trial
Acronym
Probiotics-PPI-NSAID study in Kyushu University
(POPAID study)
Scientific Title
Influence of Lactobacillus salivarius WB21 on small bowel injuries in subjects who take NSAID and PPI; a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Probiotics-PPI-NSAID study in Kyushu University
(POPAID study)
Region
| Japan |
Condition
Condition
NSAID-induced small bowel injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to ascertain the influence of Lactobacillus salivarius WB21 on small bowel injury in subjects who take nonsteroidal anti-inflammatory drug (NSAID) and proton pump inhibitor (PPI) using capsule endoscopy.
Basic objectives2
Others
Basic objectives -Others
In this randomized, double-blind, placebo-controlled trial, healthy subjects are randomly assigned groups given celecoxib, rabeprazole and placebo, or celecoxib, rabeprazole and Lactobacillus salivarius WB21.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of small bowel mucosal injuries (hemorrhage, ulcer and mucosal break) under capsule endoscopy after 2 weeks medication.
Key secondary outcomes
1) The number and incidence of small bowel mucosal injuries in the jejunum and ileum.
2) The incidence of gastroduodenal mucosal injuries.
3) Abdominal symptoms, laboratory data and gut microbiota composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects in placebo group are administered celecoxib 200 mg twice daily, rabeprazole 20 mg once daily and placebo 3.2 g twice daily for two weeks.
Interventions/Control_2
Subjects in WB21 group are administered celecoxib 200 mg twice daily and rabeprazole 20 mg once daily and Lactobacillus salivarius WB21 3.2 g twice daily for two weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers obtained written informed consent
Key exclusion criteria
1) Subjects with a history of peptic ulcers
2) Subjects treated continuously with NSAIDs, including aspirin
3) Subjects with a history of aspirin-induced asthma
4) Subjects allergic to sulufonamids
5) Subjects treated with corticosteroid, anti-ulcer drugs (misoprostol, rebamipide, teprenone, etc), or probiotics
6) Subjects with gastrointestinal stenosis or severe adhesion
7) Subjects with malignancy, psychosis, severe hepatic, renal dysfunction, heart disease, or hematologic disease
8) Pregnant and nursing women
9) Subjects with other disorders who are judged inappropriate for the participation of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanari Kitazono |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
yokamoto@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Okamoto, Toshifumi Morishita, Motohiro Esaki |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Homepage URL
yokamoto@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukuoka Sanno Hospital
Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
FS-181
Org. issuing International ID_1
Fukuoka Sanno Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福岡山王病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030256
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/03/09 | POPAID study倫理審査 計画書(第2版).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/03/14 | POPAID studyデータ.xlsx |
