UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027429 |
|---|---|
| Receipt number | 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 17:20:12 |
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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
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
takafumim@hotmail.com
Public contact
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
takafumim@hotmail.com
Sponsor or person
Institute
Tsujinaka Hospital Kashiwanoha
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031427
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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