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

NCT04375475 | Completed

• 1 other identifier: 19-SM-02-GM-001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Defecation satisfaction score

  Day 0, 3, 7, 14, 21, 28

• Bristol score of stool characteristics

  Day 0, 3, 7, 14, 21, 28

• Bristol score of stool color

  Day 0, 3, 7, 14, 21, 28

• Symptom score of digestive system

  Day 0, 3, 7, 14, 21, 28

• Fecal bacterium

  Day 0, 14

Study Arms (3)

Bright Changyou probiotic flavored yogurt

EXPERIMENTAL

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

Dietary Supplement: Bright Changyou probiotic flavored yogurt

Bright Changyou lactobacillus flavored yogurt

ACTIVE COMPARATOR

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

Dietary Supplement: Bright Changyou lactobacillus flavored yogurt

Bright flavored yogurt

ACTIVE COMPARATOR

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

Dietary Supplement: Bright flavored yogurt

Interventions

Bright Changyou probiotic flavored yogurt 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 probiotic flavored yogurt

Bright Changyou lactobacillus flavored yogurt DIETARY_SUPPLEMENT

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

Bright Changyou lactobacillus flavored yogurt

Bright flavored yogurt DIETARY_SUPPLEMENT

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

Bright flavored yogurt

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bright Dairy & Food Co., Ltd: lead

Study Sites (1)

Shanghai Jiaoton University Affiliated Xinhua Hospital

Shanghai, 200092, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: February 25, 2019
• Primary Completion: March 25, 2019
• Study Completion: April 15, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)