Intestinal HealthNCT04375475
Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health
A study testing Bright Changyou probiotic flavored yogurt, Bright Changyou lactobacillus flavored yogurt and Bright flavored yogurt in people with Intestinal Health, run by Bright Dairy & Food Co., Ltd at 1 site in China.
Trial summary
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study. The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic Flavored Yogurt on: Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Health
- What is being tested?
- Bright Changyou probiotic flavored yogurt, Bright Changyou lactobacillus flavored yogurt and Bright flavored yogurt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2019to 15 Apr 2019
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 25-45 years old;
- Functional constipation or diarrhea diagnosed by Rome III criteria;
- Agree not to take any dietary supplements or dairy products other than the study products during the study period;
- Agree not to take any supplements or dairy products containing prebiotics/probiotics other than the study products during the study period;
- Agree not to participant in other interventional studies during the study period;
- Fully understand the property, purpose, benefits and potential risk and side effect from the study;
- Agree to follow all study requirements and procedures;
- Signed informed consent.
Who cannot join
- Currently receiving treatment for gastrointestinal symptoms;
- Lactose intolerance;
- Having diseases or conditions that may affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, or Anorexia nervosa;
- Currently under diet control or in use of medicine or supplements for weight control or that might affect appetite;
- Have had laxatives or other substance that will enhance digestion within two weeks before the study begins;
- Have had dairy products or other food containing probiotics within 10 days before the study begins;
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- Currently having diarrhea;
- Currently pregnant or breast-feeding, or plan to be pregnant during the study period;
- Not be able to follow study procedures according to investigators evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaoton University Affiliated Xinhua Hospital
Shanghai, 200092
About this study
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study.
The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic Flavored Yogurt on:
Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut immunity; Adjusting microbiological flora in gastrointestinal tract.
- Conditions
- Intestinal Health
- Being tested
- Bright Changyou probiotic flavored yogurt, Bright Changyou lactobacillus flavored yogurt, Bright flavored yogurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Changyou probiotic flavored yogurtDietary supplement
Oral consumption of Bright Changyou probiotic flavored yogurt 100 g at a time and twice per day for 28 days. The experimental product has similar package and taste as the comparators.
Bright Changyou lactobacillus flavored yogurtDietary supplement
Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.
Bright flavored yogurtDietary supplement
Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Bright Changyou probiotic flavored yogurt | Experimental | Bright Changyou probiotic flavored yogurt contains 5.0×10^8cfu/g of probiotics including Lactobacillus bulgaricus, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus plantarum ST-Ⅲ (7mg/kg), and 1.5% of inulin Receives: Dietary Supplement: Bright Changyou probiotic flavored yogurt |
| Bright Changyou lactobacillus flavored yogurt | Active comparator | Bright Changyou flavored yogurt contains probiotics including Lactobacillus bulgaricus, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus plantarum ST-Ⅲ (7mg/kg) Receives: Dietary Supplement: Bright Changyou lactobacillus flavored yogurt |
| Bright flavored yogurt | Active comparator | Bright flavored yogurt contains Lactobacillus bulgaricus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium lactis, and Lactobacillus casei LC2W (0.1 mg/kg) Receives: Dietary Supplement: Bright flavored yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal health score
Change of the total gastrointestinal health score at day 28 from baseline. The total score is the sum of the 4 aspects of gastrointestinal health (each with score range from 0 to 3):
Weekly stool frequency (>=6; 4-6; 1-3; 0); Ratio of the number of unopened defecation to the total number of defecation (1; 1/4; 1/3; >=1/2); Duration of defecation (<5 minutes; 5-15 minutes; 16-30 minutes; >=30 minutes); Defecation condition (normal perception; straining/uncomfortableness at stool; obvious straining/uncomfortableness or difficulty at defecation with little feces amount; frequent abdominal or anus pain that affect defecation).
Measured: Day 0, 28
Secondary outcomes (7)
Defecation satisfaction score
Total score of the satisfaction on 4 aspects of defecation habit (each with score range from 0 to 3):
Stool frequency, defecation duration, stool characteristics, and defecation habit (very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied)
Measured: Day 0, 3, 7, 14, 21, 28
Bristol score of stool characteristics
- Separate hard lumps, like nuts;
- Sausage-shaped but lumpy;
- Like a sausage but with cracks on the surface;
- Like a sausage or snake, smooth and soft;
- Soft blobs with clear-cut edges;
- Fluffy pieces with ragged edges, a mushy stool;
- Watery, no solid pieces, entirely liquid.
Measured: Day 0, 3, 7, 14, 21, 28
Bristol score of stool color
Score from 1 to 7 for stool color from light to dark
Measured: Day 0, 3, 7, 14, 21, 28
Symptom score of digestive system
Total score of the 9 aspects of digestive symptoms (each with score range from 0 to 3 indication no symptom, light symptom, moderate symptom and severe symptom):
Bloating, abdominal pain, gastric distention, heavy stomach, loss of appetite, belching, intestinal colic, and abdominal colic.
Measured: Day 0, 3, 7, 14, 21, 28
Fecal bacterium
Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli.
Measured: Day 0, 14
Fecal short chain fatty acids
Percentage of acetic acid, propionic acid and butyric acid
Measured: Day 0, 14
Fecal secretory immunoglobulin A (sIgA)
Fecal concentration of sIgA
Measured: Day 0, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start25 Feb 2019
- Primary completion25 Mar 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Dairy & Food Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375475
- Sponsor's protocol ID
- 19-SM-02-GM-001
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health
- ClinicalTrials.gov ID
- NCT04375475
- Acronym / sponsor ID
- 19-SM-02-GM-001
- Conditions
- Intestinal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Bright Dairy & Food Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 5 May 2020 (actual)
- 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.
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study.
The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic Flavored Yogurt on:
Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut immunity; Adjusting microbiological flora in gastrointestinal tract.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bright Changyou probiotic flavored yogurt | Experimental | Dietary Supplement: Bright Changyou probiotic flavored yogurtBright Changyou probiotic flavored yogurt contains 5.0×10^8cfu/g of probiotics including Lactobacillus bulgaricus, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus plantarum ST-Ⅲ (7mg/kg), and 1.5% of inulin |
| Bright Changyou lactobacillus flavored yogurt | Active comparator | Dietary Supplement: Bright Changyou lactobacillus flavored yogurtBright Changyou flavored yogurt contains probiotics including Lactobacillus bulgaricus, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus plantarum ST-Ⅲ (7mg/kg) |
| Bright flavored yogurt | Active comparator | Dietary Supplement: Bright flavored yogurtBright flavored yogurt contains Lactobacillus bulgaricus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium lactis, and Lactobacillus casei LC2W (0.1 mg/kg) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men or women aged 25-45 years old;
- Functional constipation or diarrhea diagnosed by Rome III criteria;
- Agree not to take any dietary supplements or dairy products other than the study products during the study period;
- Agree not to take any supplements or dairy products containing prebiotics/probiotics other than the study products during the study period;
- Agree not to participant in other interventional studies during the study period;
Key exclusion criteria (9 listed)
- Currently receiving treatment for gastrointestinal symptoms;
- Lactose intolerance;
- Having diseases or conditions that may affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, or Anorexia nervosa;
- Currently under diet control or in use of medicine or supplements for weight control or that might affect appetite;
- Have had laxatives or other substance that will enhance digestion within two weeks before the study begins;
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 |
|---|---|---|
| Bright Changyou probiotic flavored yogurtOral consumption of Bright Changyou probiotic flavored yogurt 100 g at a time and twice per day for 28 days. The experimental product has similar package and taste as the comparators. | Dietary supplement | Bright Changyou probiotic flavored yogurt |
| Bright Changyou lactobacillus flavored yogurtOral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days. | Dietary supplement | Bright Changyou lactobacillus flavored yogurt |
| Bright flavored yogurtOral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days. | Dietary supplement | Bright flavored yogurt |
Primary outcome
Gastrointestinal health score
Time frame: Day 0, 28
Change of the total gastrointestinal health score at day 28 from baseline. The total score is the sum of the 4 aspects of gastrointestinal health (each with score range from 0 to 3): Weekly stool frequency (>=6; 4-6; 1-3; 0); Ratio of the number of unopened defecation to the total number of defecation (1; 1/4; 1/3; >=1/2); Duration of defecation (<5 minutes; 5-15 minutes; 16-30 minutes; >=30 minutes); Defecation condition (normal perception; straining/uncomfortableness at stool; obvious straining/uncomfortableness or difficulty at defecation with little feces amount; frequent abdominal or anus pain that affect defecation).
7 secondary outcomes
Defecation satisfaction score
Time frame: Day 0, 3, 7, 14, 21, 28
Bristol score of stool characteristics
Time frame: Day 0, 3, 7, 14, 21, 28
Bristol score of stool color
Time frame: Day 0, 3, 7, 14, 21, 28
Symptom score of digestive system
Time frame: Day 0, 3, 7, 14, 21, 28
Fecal bacterium
Time frame: Day 0, 14
Fecal short chain fatty acids
Time frame: Day 0, 14
Fecal secretory immunoglobulin A (sIgA)
Time frame: Day 0, 14
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 5 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Changyou probiotic flavored yogurt, Bright Changyou lactobacillus flavored yogurt and Bright flavored yogurt in people with Intestinal Health, run by Bright Dairy & Food Co., Ltd at 1 site in China.
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 8 inclusion and 9 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 5 May 2020. 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 China. 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. 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?
Gastrointestinal health score (time frame: Day 0, 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2020.