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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Woo Park, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01651741
First received: July 25, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Seaweed and Duolac7S
Dietary Supplement: Seaweed and Duolac7S-P

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie:

Primary Outcome Measures:
  • Change of intestinal microflora (7 strains of Lactic acid bacteria) [ Time Frame: Visit 1(0week), Visit 2(4week) ] [ Designated as safety issue: No ]
    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:
  • Daily assessment of bowel function scores [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(6week) ] [ Designated as safety issue: No ]
    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

  • KGSRS (Korean gastrointestinal symptom rating scale) [ Time Frame: Visit 1(0week), Visit 2(4week), Visit 3(6week) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Seaweed:

  1. Form: brown granule
  2. Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal)
  3. Duration: 4 weeks of treatment period

Duolac7S:

  1. The probiotics, Duolac7S, consist of 7 bacteria.
  2. Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus.
  3. Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule [7✕100,000,000 viable cells/strain]), 2 capsules per day (30 min after morning and evening meal)
  4. Duration: 4 weeks of treatment period
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).

Seaweed:

  1. Form: brown granule
  2. Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal)
  3. Duration: 4 weeks of treatment period

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 Name: Seaweed and placebo probiotics

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651741

Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, Korea, Republic of, 134-727
Sponsors and Collaborators
Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie
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
  More Information

Additional Information:
No publications provided by Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae-Woo Park, Associate Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01651741     History of Changes
Other Study ID Numbers: 911029-1
Study First Received: July 25, 2012
Last Updated: September 20, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie:
Intestinal Microbiota
Probiotics
Seaweed
Healthy Subject

ClinicalTrials.gov processed this record on April 16, 2014