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

Bright Dairy & Food

Status: Completed

Conditions: Intestinal Health

Treatments: Dietary Supplement: Bright flavored yogurt; Dietary Supplement: Bright Changyou lactobacillus flavored yogurt; Dietary Supplement: Bright Changyou probiotic flavored yogurt

Study type: Interventional

Funder types: Industry

Identifiers

NCT04375475

19-SM-02-GM-001

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 3 patient groups

Bright Changyou probiotic flavored yogurt

Experimental group

Description:

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

Treatment:

Dietary Supplement: Bright Changyou probiotic flavored yogurt

Bright Changyou lactobacillus flavored yogurt

Active Comparator group

Description:

Bright Changyou flavored yogurt contains probiotics including Lactobacillus bulgaricus, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, and Lactobacillus plantarum ST-Ⅲ (7mg/kg)

Treatment:

Dietary Supplement: Bright Changyou lactobacillus flavored yogurt

Bright flavored yogurt

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Bright flavored yogurt