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

May 4, 2020 updated by: Bright Dairy & Food Co., Ltd

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Shanghai, China, 200092
        • Shanghai Jiaoton University Affiliated Xinhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Active Comparator: 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)
Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.
Active Comparator: Bright flavored yogurt
Bright flavored yogurt contains Lactobacillus bulgaricus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium lactis, and Lactobacillus casei LC2W (0.1 mg/kg)
Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal health score
Time Frame: Day 0, 28

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defecation satisfaction score
Time Frame: Day 0, 3, 7, 14, 21, 28

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
Bristol score of stool characteristics
Time Frame: Day 0, 3, 7, 14, 21, 28
  1. Separate hard lumps, like nuts;
  2. Sausage-shaped but lumpy;
  3. Like a sausage but with cracks on the surface;
  4. Like a sausage or snake, smooth and soft;
  5. Soft blobs with clear-cut edges;
  6. Fluffy pieces with ragged edges, a mushy stool;
  7. Watery, no solid pieces, entirely liquid.
Day 0, 3, 7, 14, 21, 28
Bristol score of stool color
Time Frame: Day 0, 3, 7, 14, 21, 28
Score from 1 to 7 for stool color from light to dark
Day 0, 3, 7, 14, 21, 28
Symptom score of digestive system
Time Frame: Day 0, 3, 7, 14, 21, 28

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
Fecal bacterium
Time Frame: Day 0, 14
Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli.
Day 0, 14
Fecal short chain fatty acids
Time Frame: Day 0, 14
Percentage of acetic acid, propionic acid and butyric acid
Day 0, 14
Fecal secretory immunoglobulin A (sIgA)
Time Frame: Day 0, 14
Fecal concentration of sIgA
Day 0, 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

April 15, 2019

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 19-SM-02-GM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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