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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025356
Receipt No. R000029088
Scientific Title Study on the ameliorating effect of L.gasseri OLL2716 on functional dyspepsia in Helicobacter pylori-uninfected individuals
Date of disclosure of the study information 2016/12/22
Last modified on 2016/12/21

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Basic information
Public title Study on the ameliorating effect of L.gasseri OLL2716 on functional dyspepsia in Helicobacter pylori-uninfected individuals
Acronym Study on the ameliorating effect of L.gasseri OLL2716 on functional dyspepsia
Scientific Title Study on the ameliorating effect of L.gasseri OLL2716 on functional dyspepsia in Helicobacter pylori-uninfected individuals
Scientific Title:Acronym Study on the ameliorating effect of L.gasseri OLL2716 on functional dyspepsia
Region
Japan

Condition
Condition Functional dyspepsia
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the ameliorating effect of L.gasseri OLL2716 on functional dyspepsia in Helicobacter pylori-uninfected individuals, according for a randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Participants' impressions regarding the overall effects on gastric symptoms after 12 weeks of intake of the food products
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of L.gasseri OLL2716-containing yoghurt(85g) for 12 weeks
Interventions/Control_2 Intake of placebo yoghurt (85g) for 12 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
64 years-old >=
Gender Male and Female
Key inclusion criteria 1. Japanese nationals between the ages of 20 and 64 years, with complaints involving the epigastric region, who have not received any treatment.
2. Individuals who have one or more of the 4 symptoms of dyspepsia defined according to the Rome 3 criteria ( postprandial fullness, early satiation, epigastric pain, and epigastric burning) during the preceding 6-month period and have such symptoms regularly during the last 3 months at the time of the screening test.
3. H.pylori-negative individuals, determined as those who meet the following two conditions at the same time: PG2 less than 12 with PG 1/2 ratio not less than 4.5, and serum anti-H.pylori antibody levels (E plate:Eiken) less than 3 U/ml.
Key exclusion criteria 1. Individuals who have consulted medical institutions during the most recent six-month period for diabetes or disorders of the gastrointestinal tract.
2. Individuals who have received medical treatment for dyspepsia symptoms during the 6-month period preceding the study.
3. Individuals who have previously received oral treatments using low-dose aspirin, as well as individuals who have been regularly using non-steroidal anti-inflammatory agents during the 6-month period preceding the study
4. Individuals who are suspected of diabetes, gastrointestinal disorders and severe renal impairment on the basis of blood tests, meidical examination by interview and physical examination at the time of the screening.
5. Individuals who show a marked weight loss during the 3-month period preceding the study
6. Individuals who have experienced a moderate or severe heartburn or reflux symptoms during the 3-month period preceding the study.
7. Individuals who have previously been subjected to an H.pylori eradication therapy.
8. Individuals who have ingested lactic acid bacteria-containing food products 3 times or more per week during the 3-month period preceding the screening tests, excluding individuals who are able to discontinue their intake of the above for 2 weeks or longer preceding the baseline period.
9. Individuals who, for 3 months before the screening tests, regularly use health foods or quasi-drugs with possible influence on gastric symptoms
10. Individuals with milk allergy or food allergies
11. Individuals who, during a one-month period preceding the screening tests, participat in other clinical trials or preliminary studies.
12. Individuals who are pregnant; individuals who plan or want to become pregnant during the study period; individuals who are lactating.
13. Individuals that are considered unsuitable as study participants according to the judgement of the investigator.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohtsu Toshihiro
Organization Meiji Co., Ltd.
Division name Food Science Research Laboratories
Zip code
Address 540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL 0465-37-3617
Email toshihiro.ohtsu@meiji.com

Public contact
Name of contact person
1st name
Middle name
Last name Ohtsu Toshihiro
Organization Meiji Co., Ltd.
Division name Food Science Research Laboratories
Zip code
Address 540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL 0465-37-3617
Homepage URL
Email toshihiro.ohtsu@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 12 Month 22 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
2014 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 22 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
2016 Year 12 Month 21 Day
Last modified on
2016 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029088

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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