- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04375475
Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Shanghai, China, 200092
- Shanghai Jiaoton University Affiliated Xinhua Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bright Changyou probiotic flavored yogurt
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
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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.
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Active Comparator: Bright Changyou lactobacillus flavored yogurt
Bright Changyou flavored yogurt contains probiotics including Lactobacillus bulgaricus, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus plantarum ST-Ⅲ (7mg/kg)
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Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.
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Active Comparator: Bright flavored yogurt
Bright flavored yogurt contains Lactobacillus bulgaricus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium lactis, and Lactobacillus casei LC2W (0.1 mg/kg)
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Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Day 0, 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defecation satisfaction score
Time Frame: Day 0, 3, 7, 14, 21, 28
|
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) |
Day 0, 3, 7, 14, 21, 28
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Bristol score of stool characteristics
Time Frame: Day 0, 3, 7, 14, 21, 28
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Day 0, 3, 7, 14, 21, 28
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Bristol score of stool color
Time Frame: Day 0, 3, 7, 14, 21, 28
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Score from 1 to 7 for stool color from light to dark
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Day 0, 3, 7, 14, 21, 28
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Symptom score of digestive system
Time Frame: Day 0, 3, 7, 14, 21, 28
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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. |
Day 0, 3, 7, 14, 21, 28
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Fecal bacterium
Time Frame: Day 0, 14
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Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli.
|
Day 0, 14
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Fecal short chain fatty acids
Time Frame: Day 0, 14
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Percentage of acetic acid, propionic acid and butyric acid
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Day 0, 14
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Fecal secretory immunoglobulin A (sIgA)
Time Frame: Day 0, 14
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Fecal concentration of sIgA
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Day 0, 14
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-SM-02-GM-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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