Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Seaweed and Duolac7S; Dietary Supplement: Seaweed and Duolac7S-P

• Registration Number: NCT01651741
• Lead Sponsor: Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie

Brief Summary

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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-20
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age of 18 - 75, with a elementary-school diploma or higher, must be literate
2. One who does not have any diseases or clinical symptoms related to digestive system
3. One whose every question of KGSRS is under 3 points
4. One who agree on not taking other therapies during the trial
5. During the past 5 yrs, no history of organic lesion proven by colonoscopy
6. One who agree on consent form

Exclusion Criteria

1. Patients who have abdominal operation in the past (exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
2. Patients who have history of serious diseases (cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
3. Before participating clinical trial, one who took over-the-count medication affecting GI motility
4. One who took antibiotics, herbal medicine or probiotics within 2 wks before participating the trial
5. Pregnant woman
6. One who disagree on the consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seaweed and Duolac7S	Seaweed and Duolac7S	Seaweed: Real Seaweed granule, Duolac7S: Real probiotics
Seaweed and Duolac7S-P	Seaweed and Duolac7S-P	Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics

Primary Outcome Measures

Name	Time	Method
Change of intestinal microflora (7 strains of Lactic acid bacteria)	Visit 1(0week), Visit 2(4week)	1. To investigate the changes of intestinal microbes before and after experiment, feces should be collected.; 2. The feces will be analyzed by the method of DGGE (denaturing gradient gel electrophoresis - PCR of DNA).

Secondary Outcome Measures

Name	Time	Method
KGSRS (Korean gastrointestinal symptom rating scale)	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.
Daily assessment of bowel function scores	Visit 1(0week), Visit 2(4week), Visit 3(6week)	1. The patients should write diaries of stool's frequency, consistency and ease of passage; 2. Frequency (number of defecation in a day); 3. Consistency (judged by Bristol scale); 4. Ease of passage
WHOQOL (The World Health Organization Quality of Life) - BREF	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.

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Gangdong-gu, Korea, Republic of