Status:
COMPLETED
Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health
Lead Sponsor:
Bright Dairy & Food Co., Ltd
Conditions:
Intestinal Health
Eligibility:
All Genders
25-45 years
Phase:
NA
Brief 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: ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2019
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04375475
Start Date
February 25 2019
End Date
April 15 2019
Last Update
May 5 2020
Active Locations (1)
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1
Shanghai Jiaoton University Affiliated Xinhua Hospital
Shanghai, China, 200092