Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects
NCT ID: NCT01651741
Last Updated: 2013-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2012-05-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Seaweed and Duolac7S
Seaweed: Real Seaweed granule, Duolac7S: Real probiotics
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
Seaweed and Duolac7S-P
Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jae-Woo Park
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jae-Woo Park, KMD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jeong JH, Jo YN, Kim HJ, Jin DE, Kim DO, Heo HJ. Black soybean extract protects against TMT-induced cognitive defects in mice. J Med Food. 2014 Jan;17(1):83-91. doi: 10.1089/jmf.2013.3023.
Ko SJ, Kim J, Han G, Kim SK, Kim HG, Yeo I, Ryu B, Park JW. Laminaria japonica combined with probiotics improves intestinal microbiota: a randomized clinical trial. J Med Food. 2014 Jan;17(1):76-82. doi: 10.1089/jmf.2013.3054.
Related Links
Access external resources that provide additional context or updates about the study.
This is the URL of the site in which the clinical trial will be conducted.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
911029-1
Identifier Type: -
Identifier Source: org_study_id