Unique ID issued by UMIN | UMIN000026358 |
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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 |
Influence of Lactobacillus salivarius WB21 on small bowel injuries in subjects who take NSAID and PPI; a randomized, double-blind, placebo-controlled trial
Probiotics-PPI-NSAID study in Kyushu University
(POPAID study)
Influence of Lactobacillus salivarius WB21 on small bowel injuries in subjects who take NSAID and PPI; a randomized, double-blind, placebo-controlled trial
Probiotics-PPI-NSAID study in Kyushu University
(POPAID study)
Japan |
NSAID-induced small bowel injury
Gastroenterology |
Others
YES
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.
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.
The incidence rate of small bowel mucosal injuries (hemorrhage, ulcer and mucosal break) under capsule endoscopy after 2 weeks medication.
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Central registration
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
75 | years-old | > |
Male and Female
Healthy volunteers obtained written informed consent
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
60
1st name | |
Middle name | |
Last name | Takanari Kitazono |
Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5261
yokamoto@intmed2.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Yasuharu Okamoto, Toshifumi Morishita, Motohiro Esaki |
Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5261
yokamoto@intmed2.med.kyushu-u.ac.jp
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Other
Japan
Fukuoka Sanno Hospital
Division of Gastroenterology, Department of Internal Medicine, Iwate Medical University
YES
FS-181
Fukuoka Sanno Hospital
福岡山王病院(福岡県)
2017 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 26 | Day |
2016 | Year | 10 | Month | 14 | Day |
2017 | Year | 04 | Month | 01 | Day |
2018 | Year | 08 | Month | 31 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030256
Research Plan | |
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Registered date | File name |
2019/03/09 | POPAID study倫理審査 計画書(第2版).pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2019/03/14 | POPAID studyデータ.xlsx |