UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039738 |
|---|---|
| Receipt number | R000045297 |
| Scientific Title | Effects of formula containing fermented milk products on physical condition in enterally fed patients |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/01/31 17:03:00 |
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Basic information
Public title
Effects of formula containing fermented milk products on physical condition in enterally fed patients
Acronym
Effects of formula containing fermented milk products on physical condition in enterally fed patients
Scientific Title
Effects of formula containing fermented milk products on physical condition in enterally fed patients
Scientific Title:Acronym
Effects of formula containing fermented milk products on physical condition in enterally fed patients
Region
| Japan |
Condition
Condition
diarrhea, constipation
Classification by specialty
| Medicine in general | Gastroenterology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of 56 days nutritional management by enteral formula containing fermented milk products on defecation and nutritional status in enterally fed patients dosed with laxative
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
defecation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
56 days nutritional management by enteral formula containing fermented milk products
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals who provided written informed consent by legally acceptable guardian.
Because the subjects are unconscious, informed assent will not be obtained.
2.Enterally fed patients who dosed with laxative
Key exclusion criteria
1.Individualds who already take enteral formula containing fermented milk products
2.Individualds with liver dysfunction
3.Allergy to milk or soy
4.Individualds who judged by the principal investigator or sub investigator to be inappropriate as a subject
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tsukuru |
| Middle name | |
| Last name | Hashimoto |
Organization
Sonoda hospital
Division name
director
Zip code
661-0953
Address
2-48-7,Higashionodacho,Amagasaki-shi,hyogo-ken,661-0953,japan
TEL
06-6491-9521
hasimoto@sonodamedic.or.jp
Public contact
Name of contact person
| 1st name | Tsukuru |
| Middle name | |
| Last name | Hashimoto |
Organization
sonoda hospital
Division name
director
Zip code
661-0953
Address
2-48-7,Higashionodacho,Amagasaki-shi,hyogo-ken,661-0953,japan
TEL
06-6491-9521
Homepage URL
hasimoto@sonodamedic.or.jp
Sponsor or person
Institute
sonoda hospital
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
Meiji Institutional Review Board
Address
Nanakuni, Hachioji-shi, Tokyo, 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
園田病院（兵庫県）／sonoda hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
10
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
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045297
