Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects
Condition: Healthy
Study type: Interventional

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.
    

Intervention name(s): Seaweed and Duolac7S; Seaweed and Duolac7S-P
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Seaweed and probiotics is composed of seaweed and Duolac7S.
Seaweed:
Form: brown granule
Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal)
Duration: 4 weeks of treatment period
Duolac7S:
The probiotics, Duolac7S, consist of 7 bacteria.
Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus.
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)
Duration: 4 weeks of treatment period; Seaweed and probiotics is composed of seaweed and Duolac7S-P(Placebo Duolac7S).
Seaweed:
Form: brown granule
Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal)
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 intervention name(s): Seaweed and probiotics; Seaweed and placebo probiotics
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Intestinal Microbiota; Probiotics; Seaweed; Healthy Subject