HealthyNCT01651741
Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects
A study testing Seaweed and Duolac7S and Seaweed and Duolac7S-P in people with Healthy, run by Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seaweed and Duolac7S and Seaweed and Duolac7S-P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 - 75, with a elementary-school diploma or higher, must be literate
- One who does not have any diseases or clinical symptoms related to digestive system
- One whose every question of KGSRS is under 3 points
- One who agree on not taking other therapies during the trial
- During the past 5 yrs, no history of organic lesion proven by colonoscopy
- One who agree on consent form
Who cannot join
- Patients who have abdominal operation in the past (exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
- Patients who have history of serious diseases (cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
- Before participating clinical trial, one who took over-the-count medication affecting GI motility
- One who took antibiotics, herbal medicine or probiotics within 2 wks before participating the trial
- Pregnant woman
- One who disagree on the consent form
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, 134-727
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Seaweed and Duolac7S, Seaweed and Duolac7S-P
- Keywords
- Intestinal Microbiota, Probiotics, Seaweed, Healthy Subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seaweed and Duolac7SDietary supplement
Also called Seaweed and probiotics
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 Duolac7S-PDietary supplement
Also called Seaweed and placebo probiotics
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).
| Study group | Role | What they receive |
|---|---|---|
| Seaweed and Duolac7S | Experimental | Seaweed: Real Seaweed granule, Duolac7S: Real probiotics Receives: Dietary Supplement: Seaweed and Duolac7S |
| Seaweed and Duolac7S-P | Placebo comparator | Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics Receives: Dietary Supplement: Seaweed and Duolac7S-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of intestinal microflora (7 strains of Lactic acid bacteria)
- To investigate the changes of intestinal microbes before and after experiment, feces should be collected.
- The feces will be analyzed by the method of DGGE (denaturing gradient gel electrophoresis - PCR of DNA).
Measured: Visit 1(0week), Visit 2(4week)
Secondary outcomes (3)
Daily assessment of bowel function scores
- The patients should write diaries of stool's frequency, consistency and ease of passage
- Frequency (number of defecation in a day)
- Consistency (judged by Bristol scale)
- Ease of passage
Measured: Visit 1(0week), Visit 2(4week), Visit 3(6week)
KGSRS (Korean gastrointestinal symptom rating scale)
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.
Measured: Visit 1(0week), Visit 2(4week), Visit 3(6week)
WHOQOL (The World Health Organization Quality of Life) - BREF
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.
Measured: Visit 1(0week), Visit 2(4week), Visit 3(6week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Woo Park, Kyunghee University Medical Center
- Investigators
- Jae-Woo Park, KMD, PhD, Principal investigator, Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651741
- Sponsor's protocol ID
- 911029-1
- Status last verified
- Sep 2013
- First submitted
- 25 Jul 2012
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24456358Ko 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.
PubMed 24456357
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects: a Randomized, Double-blind, Placebo-controlled, Waiting-list Clinical Trial
- ClinicalTrials.gov ID
- NCT01651741
- Acronym / sponsor ID
- 911029-1
- Conditions
- Healthy
- Keywords
- Intestinal Microbiota, Probiotics, Seaweed, Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & FisherieUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seaweed and Duolac7S | Experimental | Dietary Supplement: Seaweed and Duolac7SSeaweed: Real Seaweed granule, Duolac7S: Real probiotics |
| Seaweed and Duolac7S-P | Placebo comparator | Dietary Supplement: Seaweed and Duolac7S-PSeaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 - 75, with a elementary-school diploma or higher, must be literate
- One who does not have any diseases or clinical symptoms related to digestive system
- One whose every question of KGSRS is under 3 points
- One who agree on not taking other therapies during the trial
- During the past 5 yrs, no history of organic lesion proven by colonoscopy
Key exclusion criteria (6 listed)
- Patients who have abdominal operation in the past (exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
- Patients who have history of serious diseases (cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
- Before participating clinical trial, one who took over-the-count medication affecting GI motility
- One who took antibiotics, herbal medicine or probiotics within 2 wks before participating the trial
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seaweed and Duolac7SAlso: Seaweed and probioticsSeaweed 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 | Dietary supplement | Seaweed and Duolac7S |
| Seaweed and Duolac7S-PAlso: Seaweed and placebo probioticsSeaweed 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). | Dietary supplement | Seaweed and Duolac7S-P |
Primary outcome
Change of intestinal microflora (7 strains of Lactic acid bacteria)
Time frame: 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).
3 secondary outcomes
Daily assessment of bowel function scores
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(6week)
KGSRS (Korean gastrointestinal symptom rating scale)
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(6week)
WHOQOL (The World Health Organization Quality of Life) - BREF
Time frame: Visit 1(0week), Visit 2(4week), Visit 3(6week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Derived from this study: PubMed 24456358Jeong 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.
- Derived from this study: PubMed 24456357Ko 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.
- This is the URL of the site in which the clinical trial will be conducted.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Woo Park, KMD, PhD principal investigator
Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seaweed and Duolac7S and Seaweed and Duolac7S-P in people with Healthy, run by Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of intestinal microflora (7 strains of Lactic acid bacteria) (time frame: Visit 1(0week), Visit 2(4week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651741, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.