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

July 25, 2012
September 20, 2013
May 2012
July 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01651741 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Healthy
  • 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
  • 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
  • Experimental: Seaweed and Duolac7S
    Seaweed: Real Seaweed granule, Duolac7S: Real probiotics
    Intervention: Dietary Supplement: Seaweed and Duolac7S
  • Placebo Comparator: Seaweed and Duolac7S-P
    Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics
    Intervention: Dietary Supplement: Seaweed and Duolac7S-P

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01651741
911029-1
Yes
Jae-Woo Park, Kyunghee University Medical Center
Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie
Not Provided
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
Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP