Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health

Intestinal Health Clinical Trial

Official title:

Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375475
• Other study ID #: 19-SM-02-GM-001
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2020
• Source: Bright Dairy & Food Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 immunity; Adjusting microbiological flora in gastrointestinal tract.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: April 15, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Health

Intervention

Dietary Supplement:
• Bright Changyou probiotic flavored yogurt
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 yogurt
Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.
• Bright flavored yogurt
Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.

Locations

Country	Name	City	State
China	Shanghai Jiaoton University Affiliated Xinhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Bright Dairy & Food Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Day 0, 3, 7, 14, 21, 28
Secondary	Bristol score of stool color	Score from 1 to 7 for stool color from light to dark	Day 0, 3, 7, 14, 21, 28
Secondary	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
Secondary	Fecal bacterium	Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli.	Day 0, 14
Secondary	Fecal short chain fatty acids	Percentage of acetic acid, propionic acid and butyric acid	Day 0, 14
Secondary	Fecal secretory immunoglobulin A (sIgA)	Fecal concentration of sIgA	Day 0, 14