Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects
|Healthy||Dietary Supplement: Seaweed and Duolac7S Dietary Supplement: Seaweed and Duolac7S-P|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects: a Randomized, Double-blind, Placebo-controlled, Waiting-list Clinical Trial|
- Change of intestinal microflora (7 strains of Lactic acid bacteria) [ Time Frame: Visit 1(0week), Visit 2(4week) ]
- To investigate the changes of intestinal microbes before and after experiment, feces should be collected.
- The feces will be analyzed by the method of DGGE (denaturing gradient gel electrophoresis - PCR of DNA).
- Daily assessment of bowel function scores [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(6week) ]
- The patients should write diaries of stool's frequency, consistency and ease of passage
- Frequency (number of defecation in a day)
- Consistency (judged by Bristol scale)
- Ease of passage
- 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.
- 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.
|Study Start Date:||May 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Seaweed and Duolac7S
Seaweed: Real Seaweed granule, Duolac7S: Real probiotics
Dietary Supplement: Seaweed and Duolac7S
Seaweed and probiotics is composed of seaweed and Duolac7S.
Other Name: Seaweed and probiotics
Placebo Comparator: Seaweed and Duolac7S-P
Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics
Dietary Supplement: Seaweed and Duolac7S-P
Seaweed and probiotics is composed of seaweed and Duolac7S-P(Placebo Duolac7S).
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 Name: Seaweed and placebo probiotics
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651741
|Korea, Republic of|
|Kyung Hee University Hospital at Gangdong|
|Seoul, Gangdong-gu, Korea, Republic of, 134-727|
|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|