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The aims of this study are to investigate the effect of seaweeds which is one of the main ingredients of Korean traditional food 'Kimchi' and probiotics on intestinal function of healthy subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seaweed and Duolac7S | Experimental | Seaweed: Real Seaweed granule, Duolac7S: Real probiotics |
|
| Seaweed and Duolac7S-P | Placebo Comparator | Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seaweed and Duolac7S | Dietary Supplement | Seaweed and probiotics is composed of seaweed and Duolac7S. Seaweed:
Duolac7S:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of intestinal microflora (7 strains of Lactic acid bacteria) |
| Visit 1(0week), Visit 2(4week) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily assessment of bowel function scores |
| Visit 1(0week), Visit 2(4week), Visit 3(6week) |
| KGSRS (Korean gastrointestinal symptom rating scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Seoul | Gangdong-gu | 134-727 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24456358 | Derived | 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. | |
| 24456357 | Derived | 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. |
| Label | URL |
|---|---|
| This is the URL of the site in which the clinical trial will be conducted. | View source |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| Seaweed and Duolac7S-P | Dietary Supplement | 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). |
|
|
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 | 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) |
| D019602 |
| Food and Beverages |