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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026358
Receipt No. 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

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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
Email 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
Email yokamoto@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.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


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