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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Dietary supplement: 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.
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)
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.
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)
Dietary supplement: Bright flavored yogurt
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bright Dairy & Food Co., Ltd

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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