UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025356
Receipt number 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 17:43:06

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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 or person

Institute

Meiji Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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