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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
198
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.
Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.
Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.
Shanghai Jiaoton University Affiliated Xinhua Hospital
Shanghai, China
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).
Time frame: Day 0, 28
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)
Time frame: Day 0, 3, 7, 14, 21, 28
Bristol score of stool characteristics
1. Separate hard lumps, like nuts; 2. Sausage-shaped but lumpy; 3. Like a sausage but with cracks on the surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear-cut edges; 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces, entirely liquid.
Time frame: Day 0, 3, 7, 14, 21, 28
Bristol score of stool color
Score from 1 to 7 for stool color from light to dark
Time frame: 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.
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Time frame: Day 0, 3, 7, 14, 21, 28
Fecal bacterium
Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli.
Time frame: Day 0, 14
Fecal short chain fatty acids
Percentage of acetic acid, propionic acid and butyric acid
Time frame: Day 0, 14
Fecal secretory immunoglobulin A (sIgA)
Fecal concentration of sIgA
Time frame: Day 0, 14