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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027429
Receipt No. R000031427
Scientific Title Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Date of disclosure of the study information 2017/06/01
Last modified on 2019/01/05

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Basic information
Public title Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Acronym Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Scientific Title Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Scientific Title:Acronym Randomised controlled trial evaluating the efficacy of prebiotics, probiotics and synbiotics in chronic constipation; A pilot study
Region
Japan

Condition
Condition Chronic constipation
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference of the efficacy between prebiotics, probiotics, and synbiotics in patients with chronic constipation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes complete spontaneous bowel movement compared baseline and 4weeks of treatments
Key secondary outcomes spontaneous bowel movement, Bristol Stool Form Scale, Constipation Scoring System (CSS), The Patient Assesment of Constipation Quality of Life (PAC-QOL), Gastrointestinal Symptoms Rating Scale (GSRS), evacuation symptoms (straining, sensation of incomplete evacuation, pain, and satisfaction), and amount of dietary fiber intake per day after 4weeks of treatments

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Control arm: nutritional guidance only
Interventions/Control_2 Prebiotics arm: water soluble dietary fiber intake 10g/day for 4 weeks following nutritional guidance
Interventions/Control_3 Probiotics arm: Bifidobacterium longum BB536 (1*10(11) CFU/day) for 4 weeks following nutritional guidance
Interventions/Control_4 Synbiotics arm: both water soluble dietary fiber (10g/day) and Bifidobacterium BB536 (1*10(11)CFU/day) for 4 weeks following nutritional guidance
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

Not applicable
Gender Male and Female
Key inclusion criteria Chronic Constipation
1)Must include 2 or more of the followings
1. Fewer than 3 spontaneous bowel movements per week
2. Straining during more than one-fourth of defecations
3. Lumpy of hard stool (BSFS1-2) more than one-fourth of defecations
4. Sensation of incomplete evacuation more than one-fourth of defecations
5. Sensation of anorectal obstruction/blockage more than one-fourth of defecations
6. Manual maneuvers to facilitate more than one-fourth of defecations
2) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
3) Loose stools are rarely present without the use of laxatives

Chronic constipation is diagnosed if patients meet criteria 1), 2), and 3).

Key exclusion criteria 1) rectal intussuspocion, rectal prolapse, and megacolon inducing constipation
2) secondary constipation due to psychiatric disorders, neurologic disorders, endcrine disorders, or medication (opioids, antidepressants, anticholinergic, calcium channel blockers, proton pump inhibitors)
3)mechanical obstruction
4)past history of inflammatory bowel diseases, colorectal cancer, or bowel obstruction
5)pregnant of lactating woman
6)renal failure (serum Cr>=2.0mg/dl), severe liver disorder (T-Bil >=3.0mg/dl or AST, ALT>=100U/L)
7)severe cardiovascular disorders
8)physician determined ineligible
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takafumi Maeda
Organization Tsujinaka Hospital Kashiwanoha
Division name Department of Surgery
Zip code
Address 148-6 Kashiwanoha Campus, 178-2 Wakashiba Kashiwa-city, Chiba
TEL 0471-37-3737
Email takafumim@hotmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Takafumi Maeda
Organization Tsujinaka Hospital Kashiwanoha
Division name Department of Surgery
Zip code
Address 148-6 Kashiwanoha Campus, 178-2 Wakashiba Kashiwa-city, Chiba
TEL 0471-37-3737
Homepage URL
Email takafumim@hotmail.com

Sponsor
Institute Tsujinaka Hospital Kashiwanoha
Institute
Department

Funding Source
Organization Taiyo Kagaku Co, LTD
Clinico Co, LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Clinical Study Support Center, Wakayama Medical University
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 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
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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 07 Month 31 Day
Date trial data considered complete
2019 Year 07 Month 31 Day
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 21 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031427

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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