UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028322 |
|---|---|
| Receipt number | R000031898 |
| Scientific Title | Gut microbiota modulation by Salacia extract in Diarrhea-dominant Irritable Bowel Syndrome: a randomized clinical trial |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/03/31 13:42:14 |
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Basic information
Public title
Gut microbiota modulation by Salacia extract in Diarrhea-dominant Irritable Bowel Syndrome: a randomized clinical trial
Acronym
Gut microbiota modulation by Salacia extract in Diarrhea-dominant Irritable Bowel Syndrome: a randomized clinical trial
Scientific Title
Gut microbiota modulation by Salacia extract in Diarrhea-dominant Irritable Bowel Syndrome: a randomized clinical trial
Scientific Title:Acronym
Gut microbiota modulation by Salacia extract in Diarrhea-dominant Irritable Bowel Syndrome: a randomized clinical trial
Region
| Japan |
Condition
Condition
Diarrhea predominant irritable bowel syndrome (IBS-D)
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether Salacia extract modulate gut microbiota and influence on the abdominal symptom and stool condition compared to placebo in diarrhea predominant irritable bowel syndrome patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of increase of the genus Bifidobacterium proportion from baseline to 4 weeks
Key secondary outcomes
Improvement rate of abdominal pain after 4 weeks
Improvement of IBS-Severity Index score
Improvement of IBS-QOL score
Improvement of Bristol stool scale
Composition of gut microbiota (amount of increase of the genus Veillonella proportion from baseline to 4 weeks, amount of increase of the genus Lactobacillus proportion from baseline to 4 weeks)
[Exploratory outcomes]
Improvement of SF-8 (QOL score)
Improvement of HADS score
Microbiota diversity (Shannon index, Chao1 index, weighted and unweighted UniFrac distances)
Prediction of the functional compositon of a metagenome using PICRUSt
Improvement of IBS-SI score in stratified analysis by each of the following 6 factors (more/less) at baseline
Correlation coefficient between the improvement of IBS-SI score and each increment of the following 6 factors at baseline to 4 weeks
[Six factors]
a. the genus Bifidobacterium (%)
b. the genus Veillonella (%)
c. the genus Lactobacillus (%)
d. the phylum Firmicutes : Bacteroides ratio
e. Shannon index
f. Chao1 index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A : Oral administration of Salacia extract tablets (120mg b.i.d, daily) to subjects for 4 weeks
Interventions/Control_2
B : Oral administration of placebo to subjects 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as diarrhea predominant irritable bowel syndrome by the Rome-III criteria
Key exclusion criteria
1. Patients with lactation, pregnancy or possibility of pregnancy.
2. Patients with surgical history of gastrointestinal tract
3. Patients with active inflammatory bowel disease
4. Patients with Celiac disease
5. Patients with organ failure
6. Patients who were administered antibiotics within 4 weeks
7. Patients who took materials containing Salacia extract within 4 weeks
8. Other patients who are deemed inappropriate by the attending physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Sumiyama |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1068461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, japan
TEL
0334331111
kaz_sum@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Furuhashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, japan
TEL
0334331111
Homepage URL
ms04furuhashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University
Isshi Gastrointestinal Clinic
Uchiyama Icho-ka Clinic
Fuji City General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of The jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
03-3433-1111
rinri@jikei.ac.jp
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
| 2018 | 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
45
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
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031898
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/10/25 | Salalcia計画書⑭のコピー.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
