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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024673 |
Receipt No. | R000028383 |
Scientific Title | A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans |
Date of disclosure of the study information | 2016/11/01 |
Last modified on | 2017/12/28 |
Basic information | ||
Public title | A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans | |
Acronym | A trial for improving the intestinal environment in humans | |
Scientific Title | A randomized double-blind placebo-controlled trial for improving the intestinal environment in humans | |
Scientific Title:Acronym | A trial for improving the intestinal environment in humans | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the improvement of intestinal environment to ingest the test food. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. Enterobacterial flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium cluster XVIII, and Clostridium subcluster XIVa)
*1 Perform the test at 0 week and at 1 and 2 weeks after ingestion |
Key secondary outcomes | 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion 2. Stool form scale *2 Perform the test at 0 week and at 1 and 2 weeks after the ingestion 3. Bowel movement diary *3 Record it when having bowel movements |
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 |
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Interventions/Control_1 | Duration: 2 weeks
Test material: White Lactic acid bacterium Onakani Yell Dose: A bottle (65 mL) of per day Administration: Drink it after breakfast, lunch or dinner. |
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Interventions/Control_2 | Duration: 2 weeks
Test material: Placebo Dose: A bottle (65 mL) of per day Administration: Drink it after breakfast, lunch or dinner. |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Healthy Japanese adults
2. Persons who defecate two to five times per week |
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Key exclusion criteria | 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who being treated or have medical history for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage and/or food 4. Subjects who currently take medicines (include herbal medicines) and/or supplements 5. Subjects who are allergic to medicines or relate to the test food of this trial 6. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period 7. Subjects who have enrolled into other clinical trials within the last 3 months before the date signed written informed consent in this trial 8. Subjects are judged as unsuitable for participating in this trial by physician for other reasons |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | |||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo. | ||||||
TEL | 03-3818-0610 | ||||||
kazu@orthomedico.jp |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | |||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | White Food Industry Co. Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Seishin-kai Medical Association Inc, Takara Medical Clinic. |
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 | 医療法人社団 盛心会 タカラクリニック
Seishin-kai Medical Association Inc, Takara Medical Clinic. |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | Iwasaki S, Yokoi K, Suzuki N, Yamashita S, Iio S, Takara T. Effects of a Drink Containing Lactobacillus casei on Improving the Intestinal Environment in People with Constipation-A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2017; 45(12): 1947-1962. |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028383 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |