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

August 23, 2012
October 24, 2012
May 2009
June 2009   (final data collection date for primary outcome measure)
Change in constipation condition after 3 weeks [ Time Frame: Baseline & 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01682798 on ClinicalTrials.gov Archive Site
Change in gut resident flora after 3 weeks [ Time Frame: Baseline & 3 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Yili "Changqing" Pro-ABB Yoghurt in the Improvement of Human Gastrointestinal Tract System
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Constipation
  • Dyspepsia
  • Flatulence
  • Abdominal Pain
  • Dietary Supplement: Placebo yoghurt
    100g of placebo yoghurt will be taken 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.
  • 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.
  • 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.
    Intervention: Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
  • 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.
    Intervention: Dietary Supplement: Placebo yoghurt
  • 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.
    Intervention: Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
25 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01682798
YL/LC-001
Not Provided
Inner Mongolia Yili Industrial Group Co., Ltd
Inner Mongolia Yili Industrial Group Co., Ltd
Not Provided
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..
Inner Mongolia Yili Industrial Group Co., Ltd
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP