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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inner Mongolia Yili Industrial Group Co., Ltd
ClinicalTrials.gov Identifier:
NCT01682798
First received: August 23, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Constipation
Dyspepsia
Flatulence
Abdominal Pain
 Dietary Supplement: Placebo yoghurt
Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Clinical Research on the Efficiency of Yili "Changqing" Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inner Mongolia Yili Industrial Group Co., Ltd:

Primary Outcome Measures:
  • Change in constipation condition after 3 weeks [ Time Frame: Baseline & 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in gut resident flora after 3 weeks [ Time Frame: Baseline & 3 Weeks ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682798

Locations
China, Beijing
NanMoFang Community Health Service Center
ChaoYang District, Beijing, China
China, Shanghai
JuQuan Community Health Service Center
Gucun, Baoshan District,, Shanghai, China
Sponsors and Collaborators
Inner Mongolia Yili Industrial Group Co., Ltd
Investigators
Study Director: Ying An, Ph.D Inner Mongolia Hilo Industrial Group Co., Ltd
Principal Investigator: Donglian Cai Changhai Hospital of Shanghai, Nutriology Dept.
Principal Investigator: Xinwang Gao Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine Dept..
  More Information

No publications provided

Responsible Party: Inner Mongolia Yili Industrial Group Co., Ltd
ClinicalTrials.gov Identifier: NCT01682798     History of Changes
Other Study ID Numbers: YL/LC-001
Study First Received: August 23, 2012
Last Updated: October 24, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Abdominal Pain
Constipation
Dyspepsia
Flatulence
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
 Dihydrotachysterol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013