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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027059
Receipt No. 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

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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
Email 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
Email zbm05143@sky.zero.ad.jp

Sponsor
Institute Mejiro Second General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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