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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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-â…¢ (7mg/kg) |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Changyou probiotic flavored yogurt | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 0, 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 0, 3, 7, 14, 21, 28 |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on self-representation of gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaoton University Affiliated Xinhua Hospital | Shanghai | 200092 | China |
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| Bright Changyou lactobacillus flavored yogurt | Dietary Supplement | Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days. |
|
| Bright flavored yogurt | Dietary Supplement | Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days. |
|
| Bristol score of stool characteristics |
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| Day 0, 3, 7, 14, 21, 28 |
| Bristol score of stool color | Score from 1 to 7 for stool color from light to dark | 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. | Day 0, 3, 7, 14, 21, 28 |
| Fecal bacterium | Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli. | Day 0, 14 |
| Fecal short chain fatty acids | Percentage of acetic acid, propionic acid and butyric acid | Day 0, 14 |
| Fecal secretory immunoglobulin A (sIgA) | Fecal concentration of sIgA | Day 0, 14 |