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

NCT ID: NCT04375475

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2019-04-15

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:

Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut immunity; Adjusting microbiological flora in gastrointestinal tract.

Conditions

Intestinal Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Bright Changyou probiotic flavored yogurt

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Bright Changyou lactobacillus flavored yogurt

Intervention Type: 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

Bright flavored yogurt contains Lactobacillus bulgaricus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium lactis, and Lactobacillus casei LC2W (0.1 mg/kg)

Group Type: ACTIVE_COMPARATOR

Bright flavored yogurt

Intervention Type: DIETARY_SUPPLEMENT

Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Bright flavored yogurt

Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bright Dairy & Food Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Jiaoton University Affiliated Xinhua Hospital

Shanghai, , China

Countries

China

Other Identifiers

19-SM-02-GM-001

Identifier Type: -

Identifier Source: org_study_id