- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651741
Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects
Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects: a Randomized, Double-blind, Placebo-controlled, Waiting-list Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Kimchi is one of the the typical and main foods in Korea. Seaweed is one of the important ingredient of Kimchi and has been known to have antiinflammatory, anticoagulant and antiadhesive effects. As seaweeds are fermented in order to make Kimchi, it can encourage beneficial probiotics to grow and lead to preventing digestive problems such as constipation and diarrhea.
In this trial, we are going to investigate the effect of combination of seaweeds and probiotics on intestinal function of healthy subject by evaluating intestinal microbiota. The trial is a randomized, double-blinded, placebo-controlled, 2-arm study. Forty patients with normal intestinal condition will be randomly assigned to one of the 2 groups consisting of Seaweed with real probiotics or Seaweed with placebo probiotics. The assigned treatments will last for 4 weeks and the follow-up period will be 2 weeks.
Four weeks of administration of seaweeds and probiotics is expected to increase the amount of beneficial microbiota and reduce that of harmful microbiota in intestine. we will also use questionnaires such as K-GSRS (Korean Gastrointestinal symptom rating scale), WHOQOL (The World Health Organization Quality of Life) - BREF and Assessment of bowel function scores (frequency, consistency, ease of passage - based on Bristol stool scale) to assess the change of digestive symptoms and the quality of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gangdong-gu
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Seoul, Gangdong-gu, Korea, Republic of, 134-727
- Kyung Hee University Hospital at Gangdong
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age of 18 - 75, with a elementary-school diploma or higher, must be literate
- One who does not have any diseases or clinical symptoms related to digestive system
- One whose every question of KGSRS is under 3 points
- One who agree on not taking other therapies during the trial
- During the past 5 yrs, no history of organic lesion proven by colonoscopy
- One who agree on consent form
Exclusion Criteria:
- Patients who have abdominal operation in the past (exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
- Patients who have history of serious diseases (cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
- Before participating clinical trial, one who took over-the-count medication affecting GI motility
- One who took antibiotics, herbal medicine or probiotics within 2 wks before participating the trial
- Pregnant woman
- One who disagree on the consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Seaweed and Duolac7S
Seaweed: Real Seaweed granule, Duolac7S: Real probiotics
|
Seaweed and probiotics is composed of seaweed and Duolac7S. Seaweed:
Duolac7S:
Other Names:
|
PLACEBO_COMPARATOR: Seaweed and Duolac7S-P
Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics
|
Seaweed and probiotics is composed of seaweed and Duolac7S-P(Placebo Duolac7S). Seaweed:
Duolac7S-P: Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of intestinal microflora (7 strains of Lactic acid bacteria)
Time Frame: Visit 1(0week), Visit 2(4week)
|
|
Visit 1(0week), Visit 2(4week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily assessment of bowel function scores
Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(6week)
|
|
Visit 1(0week), Visit 2(4week), Visit 3(6week)
|
KGSRS (Korean gastrointestinal symptom rating scale)
Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(6week)
|
GSRS(Gastrointestinal symptom rating scale) is composed of 15 questions associated with various digestive problems such as abdominal pain, gastrointestinal reflux, indigestion, diarrhea and constipation. KGSRS, the Korean version of GSRS, reflects the language and sociocultural environment of Korea. The reliability and validity was confirm by Gwan et al.,2008. |
Visit 1(0week), Visit 2(4week), Visit 3(6week)
|
WHOQOL (The World Health Organization Quality of Life) - BREF
Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(6week)
|
WHOQOL - BREF consists of 4 categories and 26 questions assessing various types of quality of life such as physical, psychological, social relationships and environment function.
|
Visit 1(0week), Visit 2(4week), Visit 3(6week)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jae-Woo Park, KMD, PhD, Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea
Publications and helpful links
General Publications
- Jeong JH, Jo YN, Kim HJ, Jin DE, Kim DO, Heo HJ. Black soybean extract protects against TMT-induced cognitive defects in mice. J Med Food. 2014 Jan;17(1):83-91. doi: 10.1089/jmf.2013.3023.
- Ko SJ, Kim J, Han G, Kim SK, Kim HG, Yeo I, Ryu B, Park JW. Laminaria japonica combined with probiotics improves intestinal microbiota: a randomized clinical trial. J Med Food. 2014 Jan;17(1):76-82. doi: 10.1089/jmf.2013.3054.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 911029-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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