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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016746
Receipt No. R000019422
Scientific Title Multicenter Randomized Double-blind Controlled Trial on Efficacy of Lactobacillus gasseri OLL2716 for Helicobacter pylori infection: Impact of probiotics on dyspeptic symptoms
Date of disclosure of the study information 2015/03/14
Last modified on 2015/03/09

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Basic information
Public title Multicenter Randomized Double-blind Controlled Trial on
Efficacy of Lactobacillus gasseri OLL2716 for Helicobacter
pylori infection: Impact of probiotics on dyspeptic
symptoms
Acronym Efficacy of L. gasseri in dyspeptic subjects
Scientific Title Multicenter Randomized Double-blind Controlled Trial on
Efficacy of Lactobacillus gasseri OLL2716 for Helicobacter
pylori infection: Impact of probiotics on dyspeptic
symptoms
Scientific Title:Acronym Efficacy of L. gasseri in dyspeptic subjects
Region
Japan

Condition
Condition H. pylori infection with dyspepsia
Classification by specialty
Gastroenterology Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary end-point was a decrease in the bacterial load as assessed by the 13C urea breath test and H. pylori stool antigen test OD value, and the secondary end-point was improvements in gastric mucosal inflammation as assessed by serum pepsinogen I/II measuremenst and and changes in dyspeptic symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes he urea breath test was performed, and subjects fasted on the day of testing. Serum pepsinogen (PG) was measured and H. pylori stool antigen detection was evaluated.
UBT, serum pepsinogen, and stool antigen detection were performed before and after consumption of the test product.
Key secondary outcomes Gastrointestinal symptoms were assessed using a visual analogue scale (VAS). Each participant kept a diary during consumption of the test product to record compliance and gastrointestinal symptoms (upper abdominal pain, bloating, indigestion, nausea, vomiting, and heartburn).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Yogurt containing L. gasseri OLL2716 (90 g) was consumed once daily for 12 weeks.
Interventions/Control_2 placebo yogurt (identical in appearance and taste
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria for participation were age over 30 years and confirmed H. pylori positivity.
Key exclusion criteria included organic disorders, such as gastric cancer, gastric ulcers, duodenal ulcers, pyloric stenosis, use of NSAIDs, antibiotic treatment before the study, use of PPIs or H2 antagonists, H. pylori eradication therapy within 6 months before the study, ingestion of yogurt or lactic acid bacteria beverages, and the use of antiflatulence agents.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Takagi
Organization Tokai University School of Medicine
Division name General Internal Medicine
Zip code
Address 143, Shimokasuya, Isehara, Japan
TEL 0463-93-1121
Email takagia@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Takagi
Organization Tokai University School of Medicine
Division name General Internal Medicine
Zip code
Address 143, Shimokasuya, Isehara
TEL 0463-93-1121
Homepage URL
Email takagia@is.icc.u-tokai.ac.jp

Sponsor
Institute Study group of LG
Institute
Department

Funding Source
Organization Tokai University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 09 Day
Last modified on
2015 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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