UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015735 |
|---|---|
| Receipt number | R000018312 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement. |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2014/11/21 18:30:08 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement.
Acronym
A clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement.
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement.
Scientific Title:Acronym
A clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement.
Region
| Japan |
Condition
Condition
Anemia
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy of Bifidobacterium longum BB536 ingestion in improvement of anemia via ameliorating intestinal environment for adult women having a slight anemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
hemoglobin, red blood cell, serum ferritin
Key secondary outcomes
hematocrit, serum transferrin, total iron binding capacity (TIBC), reticular red count, total serum iron, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), transferrin-saturation, defecation frequency, fecal property
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of 2 capsules containing Bifidobacterium longum BB536 for 12 weeks.
Interventions/Control_2
Daily ingestion of 2 placebo capsules devoid of Bifidobacterium longum BB536 for 12 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
Female
Key inclusion criteria
(1) Adult women who are 20 to 65 years old at the time of agreement acquisition
(2) Subjects whose Hb levels were less than 13 g/dL by a medical examination of 2014.
Key exclusion criteria
(1)Subjects who regularly uses the health foods such as supplements for the purpose of iron medicine or the iron supply.
(2)Subjects who have serious disease
(liver, kidney, cerebrovascular, endocrine metabolic diseases, infectious diseases that requires notification) needed to notify
(3)Subjects receiving treatment or medication for cancer, and subjects with a history of cancer.
(4)Subjects who have a history of major surgery of digestive system
(5)Subject with irritable bowel syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction
(6)Subject who regularly undertakes
medication or treatment that affects bowel motion (such as: antibiotics, antiflatulents, laxatives, anti-diarrheal drug) or functional food / nutraceuticals, health supplements (such as: lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber)
(7)Subject with a history of allergy to medicine and food
(8)Subject who donated: 400 ml whole blood within past 12 weeks or 200 ml whole blood within past 4 weeks or plasma or platelets within past 2 weeks prior to this study
(9)Subject who is judged to be ineligible due to subject's background, physical findings, medical examination, physical and clinical examination by principal investigator or sub investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Taeko Shimoda |
Organization
Tokyo Healthcare University
Division name
Faculty of Healthcare, Division of Medical Nutrition
Zip code
Address
3-11-1, Setagaya, Setagaya-Ward, Tokyo, 154-8586, Japan
TEL
03-5799-3711
t-shimoda@thcu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Prof. Taeko Shimoda |
Organization
Tokyo Healthcare University
Division name
Faculty of Healthcare, Division of Medical Nutrition
Zip code
Address
3-11-1, Setagaya, Setagaya-Ward, Tokyo, 154-8586, Japan
TEL
03-5799-3711
Homepage URL
t-shimoda@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
東京医療保健大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 21 | 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
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 21 | Day |
Last modified on
| 2014 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018312
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
