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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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11 March 2019 |
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Main ID: |
KCT0000448 |
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Date of registration:
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2012-05-24 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Analysis of fecal microbiota and effectiveness of synbiotics in patients with functional constipation : C-club multicenter study
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Scientific title:
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Analysis of fecal microbiota and effectiveness of synbiotics in patients with functional constipation : C-club multicenter study |
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Date of first enrolment:
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2012-04-02 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=2141 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Others, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : Not Applicable
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Phase:
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Not applicable
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Seong-Eun
Kim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ewha Womans University Medical Center |
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Name:
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Seong-Eun
Kim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ewha Womans University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)20-60 year old patients
2)patients fulfilling Rome III criteria for functional constipation and their age- and sex-matched controls
Exclusion criteria: 1) pregnant or breastfeeding women
2) organic bowel disease
3) diagnosed with advanced adenoma within 3 years
4) irritable bowel disease(Rome III)
5) OP history of bowel surgery or cholecystectomy
6) lactose malabsorption
7) DM or severe medical disease(heart and lung, liver and kidney, malignancy, immunocompromised patients)
8)Heavy alcoholics
9)difficult to Cooperate
10) antibiotics, probiotics, or synbiotics within 1 month.
Age minimum:
20(Year)
Age maximum:
60(Year)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases of the digestive system
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Intervention(s)
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Dietary Supplement : Thirty patients fulfilling Rome III criteria for functional constipation and 30 controls were enrolled. Fecal samples were obtained before and after taking VSL#3 powder (450 billion lyophilizedbacteria/sachet twice a day) for 2 weeks.
The changes of stool consistency and spontaneous bowel movement frequency per week(SBMF) of patients were investigated using the Bristol stool form chart. Fecal microbiological analyses for 5 species (Lactobacillus, Bifidobacterium, Escherichia, Bacteroides and Clostridium spp.) were performed using quantitative real-time PCR.
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Primary Outcome(s)
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difference of gut microbiome between functional constipation and control, and the influences of a probiotic , VSL#3 on the microflora of each group
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Secondary Outcome(s)
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Influence of probiotics on bowel symptom of constipation patients
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Source(s) of Monetary Support
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NAMU, VSL#3
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The Korean Society of Neurogastroenterology and Motility
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Ethics review
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Status: Submitted approval
Approval date:
Contact:
Ewha Woman's University Mokdong Hospital Institutional Review Board
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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