UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034571 |
|---|---|
| Receipt number | R000039292 |
| Scientific Title | Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain. |
| Date of disclosure of the study information | 2018/10/19 |
| Last modified on | 2019/05/08 17:15:31 |
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Basic information
Public title
Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Acronym
Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Scientific Title
Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Scientific Title:Acronym
Investigation of the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of continuous ingestion of the test foods on stress and diarrhea with abdominal pain in Japanese men and women aged 20 to 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation questionnaire
Key secondary outcomes
Izumo scale, POMS2 abbreviations, blood cytokines (IL-10, IL-6, TNF-a), faecal mucins, and faecal IgAs
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test foods (tablet 250 mg) consumed 1 tablet per day for 8 weeks.
Interventions/Control_2
Placebo foods (tablet 250 mg) consumed 1 tablet per day for 8 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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged 20 to 65 years at the time of informed consent.
2)Persons who are routinely stressed and suffer from diarrhea with abdominal pain and discomfort.
3)Persons who can continuously consume the test food for 8 weeks during the test period.
4)Persons who can visit the medical institution during the study period.
5)Persons who are judged not to be a sick person by an inquiry from a physician.
6)Persons who have received sufficient explanation on the purpose and content of the research, who have the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who have given written consent to participate in the research.
Key exclusion criteria
1)Persons who are currently receiving any drug treatment or ambulatory treatment.
2)Persons who are currently exercising or taking diet under the supervision of a physician.
3)Persons who can't restrict drugs that may affect bowel movements, health foods containing lactobacilli and bifidobacteria, foods for specified health uses, Foods with Function Claims, health supplements, supplements, etc., and foods rich in lactobacilli from the time of acquisition of consent.
4)Patients with gastrointestinal diseases that have an effect on intestinal regulation and who are currently being treated at a medical institution or who have had gastrointestinal surgery (excluding appendectomy).
5)Persons with a history of a disease that is thought to have a major impact on bowel movements.
6)Patients with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
7)Having a history of drug or food allergy.
8)Pregnant or breastfeeder. Those who desire pregnancy and lactation.
9)Persons who can't maintain their usual alcohol intake during the study period.
10)Persons who have donated blood or vaccinated within the past 3 months or scheduled them during the study.
11)Persons with psychiatric disorders or sleep disorders who have a history of psychiatric illness in the past.
12)Alcohol-dependent, drug-dependent, or drug-abused persons who have a history of such treatment.
13)Night workers and shift workers.
14)Persons with irregular habits such as meals and sleep.
15)Persons who have participated in other clinical trials within the past 3 months.
16)Persons who are difficult to record in various questionnaires.
17)Persons who are judged inappropriate for the study by the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.co.jp
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
| 2018 | Year | 10 | Month | 19 | 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
70
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
| 2018 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 19 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039292
