UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033031
Receipt No. R000037498
Scientific Title Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation
Date of disclosure of the study information 2018/06/18
Last modified on 2019/02/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation
Acronym Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation
Scientific Title Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation
Scientific Title:Acronym Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation
Region
Japan

Condition
Condition Chronic Constipation
Classification by specialty
Gastroenterology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of Bifidobacterium longum BB536 for chronic constipation

To analyze the change of intestinal microbiota for eldary patients by intake of probiotics
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes constipation scoring system(CSS)
Key secondary outcomes Bristol Stool Scale (BSS)
FSSG(frequency scale for the symptoms of GERD)
Izumo scale
intestinal bacterial flora

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
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Investigational Treatment: Bifidobacterium longum BB536 o.d. p.o. 4 weeks
Interventions/Control_2 Comparative treatment: Placebo o.d.
p.o. 4 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Age 65 or older

2)Patients with chronic constipation who satisfy the clinical criteria :
a)Functional constipation or Constipation-predominant irritable bowel syndrome diagnosed by Rome4
b)constipation scoring system: 6 or more

3)Written informed consent provided
for study participation

Key exclusion criteria 1)Parkinson's disease, multiple sclerosis, cerebral infection, spinal cord lesion

2)uncontrolled Diabetes mellitus, Hypothyroidism, Uremia

3)Users of Opioid, Anticholinergics, Anticonvulsants, Antiemetics

4)Amyloidosis, systemic sclerosis, heavy metal poisoning

5)Severe disease(cerebro-vascular, he
art, liver, renal , gastro-intestinal, end
ocrine-metabolic, infectious disease).
Cancer of the alimentary system. After
gastrointestinal tract resection. Inflam
matory bowel disease(IBD).

6)Users of antibiotic, medicine for intestinal disorders, irritative laxative, antidiarrheic and health food, supplement (lactic acid bacterium, bifidus bacillus, oligosaccharide,dietary fiber)

7) Remarkable abnormality for blood p
ressure, blood test. Severe anemia. All
ergy for drug and food. Heavy smoker,
drinker. Irregular lifestyle such as a m
eal, the sleep.

8) Considered by the principal investig
ator to be ineligible.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeda
Organization Juntendo Tokyo Koto Geriatric Medical
Center
Division name Department of Gastroenterology
Zip code
Address 3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan
TEL +81-3-5632-3111
Email t-takeda@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Takeda
Organization Juntendo Tokyo Koto Geriatric Medical Center
Division name Department of Gastroenterology
Zip code
Address 3-3-20, Shinsuna, Koto-ku Tokyo, 136-0075, Japan
TEL +81-3-5632-3111
Homepage URL
Email t-takeda@juntendo.ac.jp

Sponsor
Institute Juntendo Tokyo Koto Geriatric Medical Center
Department of Gastroenterology
Institute
Department

Funding Source
Organization University of Juntendo, intestinal flora
research course
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 順天堂東京江東高齢者医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 18 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 18 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
2018 Year 06 Month 18 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.