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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028322
Receipt No. 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

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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
Email 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
Email ms04furuhashi@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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