UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016746 |
|---|---|
| Receipt number | 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 14:19:22 |
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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
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
takagia@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Study group of LG
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019422
