UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027059 |
|---|---|
| Receipt number | R000031017 |
| Scientific Title | Effect of nutrition formula continuing dietary fiber MT-001 on intestinal flora. |
| Date of disclosure of the study information | 2017/04/19 |
| Last modified on | 2019/03/30 14:44:58 |
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Basic information
Public title
Effect of nutrition formula continuing dietary fiber MT-001 on intestinal flora.
Acronym
Effect of nutrition formula continuing dietary fiber MT-001 on intestinal flora.
Scientific Title
Effect of nutrition formula continuing dietary fiber MT-001 on intestinal flora.
Scientific Title:Acronym
Effect of nutrition formula continuing dietary fiber MT-001 on intestinal flora.
Region
| Japan |
Condition
Condition
Eating disorder and dysphagia
Classification by specialty
| Gastroenterology | Neurology | Geriatrics |
| Gastrointestinal surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Nutrition formula continuing dietary fiber MT-001 for intestinal flora.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal Microbiota
Key secondary outcomes
Short-chain fatty acid analyses
Feces pH
Physical examination
Plasma biochemical analyses
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
Supplementation:Test nutrition fomula containing of dietary fiber is administered by tube feeding at three times daily (morning.day.night)
Period:28 days after post operative period.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with tube feeding for eating disorder and malnutrition in hospital
Key exclusion criteria
1) With complications
2) TPN implementation cases
3) It becomes a clinical problem have an infection
4) Patients with respiratory failure
5) Patients with antimicrobial
6) eGFR stage 4 or less
7) Patients with severe liver dysfunction
8) Patients with diabetes
9) Patients with allergy for nutrition formula continuing dietary fiber MT-001.
10) Patients with previous hypersensitivity for nutrition formula continuing dietary fiber MT-001.
11) Previously used nutrition formula continuing dietary fiber MT-001/MT-002.
12) Patients with supplementation contaning dietary fiber
13) Research doctor is determined that inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Mizuno |
Organization
Mejiro Second General Hospital
Division name
Department of Surgery
Zip code
197-0011
Address
1980 Hussa,Hussa,Tokyo, 197-0011,Japan
TEL
042-553-3511
zbm05143@sky.zero.ad.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Mizuno |
Organization
Mejiro Second General Hospital
Division name
Department of Surgery
Zip code
197-0011
Address
1980 Hussa, Hussa, Tokyo, 197-0011, Japan
TEL
042-553-3511
Homepage URL
zbm05143@sky.zero.ad.jp
Sponsor or person
Institute
Mejiro Second General Hospital
Institute
Department
Personal name
Funding Source
Organization
Terumo 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
Mejiro Second General Hospital Ethics judgement Commission
Address
1980 Hussa, Hussa, Tokyo, 197-0011, Japan
Tel
042-553-3511
zbm05143@sky.zero.ad.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
医療法人社団悦伝会 目白第二病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
11
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
| 2017 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031017
