UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020090 |
|---|---|
| Receipt number | R000022234 |
| Scientific Title | The Effect of Kiwifruit on Constipation with or without Irritable Bowel Syndrome |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2024/09/16 23:15:06 |
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Basic information
Public title
The Effect of Kiwifruit on Constipation with or without Irritable Bowel Syndrome
Acronym
Kiwifruit on Constipation
Scientific Title
The Effect of Kiwifruit on Constipation with or without Irritable Bowel Syndrome
Scientific Title:Acronym
Kiwifruit on Constipation
Region
| Japan | Australia | Europe |
Condition
Condition
irritable bowel syndrome with constipation (IBS-C)
functional constipation (FC)
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that taking kiwifruit improves symptoms in IBS-C and FC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
complete spontaneous bowel movement (CSBM)
4 weeks
Key secondary outcomes
spontaneous bowel movement (SBM)
GI symptoms
GI motility
blood examination
gut microbiota
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
kiwifruit 2 per day for 4 weeks-(wash out period)-psyllium 7.5 g per day for 4 weeks
Interventions/Control_2
psyllium 7.5 g per day for 4 weeks-(wash out period)-kiwifruit 2 per day for 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Rome III criteria
Key exclusion criteria
Potential participants will be excluded if they have any alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD.
Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal chord injury, stroke.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba, Sendai 980-8575 Japan
TEL
022-717-8214
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Ohkawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba, Sendai 980-8575 Japan
TEL
022-717-8160
Homepage URL
pesopesogin1325@yahoo.co.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Zespri International Ltd, NZ
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
New Zealand
Other related organizations
Co-sponsor
University of Otago
University of Bologna
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
Tohoku University Graduate School of Medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022234
