Study of Yili "Changqing" Pro-ABB Yoghurt in the Improvement of Human Gastrointestinal Tract System

October 24, 2012 updated by: Inner Mongolia Yili Industrial Group Co., Ltd

The Clinical Research on the Efficiency of Yili "Changqing" Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System

The purpose of this study is to determine whether Yili "Chang Qing" Pro-ABB yoghurt is effective in improving mild constipation and the intestinal micro-ecology environment & alimentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

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

  • China
    • Beijing
      • ChaoYang District, Beijing, China
        • NanMoFang Community Health Service Center
    • Shanghai
      • Gucun, Baoshan District,, Shanghai, China
        • JuQuan Community Health Service Center

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:

  1. Male or female subjects, 25-45 yrs;
  2. Non-specific and/or moderate constipation;
  3. Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
  4. Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week).

Exclusion Criteria:

  1. Diagnosed as chronic constipation;
  2. Treated gastrointestinal symptoms;
  3. Lactose Intolerance;
  4. Treatment by analgesic such as aspirin and paracetamol;
  5. Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
  6. Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
  7. Currently suffering from diarrhea.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
100g of Yili "Chang Qing" Pro-ABB yoghurt (Formula 1) will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
Dietary supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
100g of Yili "Chang Qing" Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
PLACEBO_COMPARATOR: Placebo yoghurt
100g of placebo yoghurt (normal yoghurt) will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
Dietary supplement: Placebo yoghurt
100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
ACTIVE_COMPARATOR: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
100g of Yili "Chang Qing" Pro-ABB yoghurt (Formula 2) will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.
Dietary supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
Other Names:
  • 100g of Yili "Chang Qing" Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in constipation condition after 3 weeks
Time Frame: Baseline & 3 weeks
Baseline & 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in gut resident flora after 3 weeks
Time Frame: Baseline & 3 Weeks
Baseline & 3 Weeks

Collaborators and Investigators

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

Sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

Investigators

  • Principal Investigator: Xinwang Gao, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine Dept..

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

May 1, 2009

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (ESTIMATE)

September 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YL/LC-001

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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