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

NCT01682798 — Not applicable, Completed, 400 participants, Inner Mongolia Yili Industrial Group Co., Ltd

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

RegistryNCT01682798
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment400 (Actual)
SponsorInner Mongolia Yili Industrial Group Co., Ltd (Industry)
ConditionsConstipation, Dyspepsia, Flatulence, Abdominal Pain
InterventionsPlacebo yoghurt, Yili "Chang Qing" Pro-ABB yoghurt (Formula 1), Yili "Chang Qing" Pro-ABB yoghurt (Formula 2) (Dietary supplement)
Datesstart 2009-05-01, primary completion 2009-06-01, completion 2009-07-01, first posted 2012-09-11, last updated 2012-10-25
Locations2 sites in China

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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)Active comparatorDietary Supplement: 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.
Placebo yoghurtPlacebo comparatorDietary Supplement: Placebo yoghurt100g of placebo yoghurt (normal yoghurt) will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)Active comparatorDietary Supplement: 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.
  • Placebo yoghurt (Dietary supplement): 100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
  • Yili "Chang Qing" Pro-ABB yoghurt (Formula 1) (Dietary supplement): 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.
  • Yili "Chang Qing" Pro-ABB yoghurt (Formula 2) (Dietary supplement), also known as 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.

+Outcome measures

Primary outcomes

  • Change in constipation condition after 3 weeks [Baseline & 3 weeks]

Secondary outcomes

  • Change in gut resident flora after 3 weeks [Baseline & 3 Weeks]

+Eligibility

Sex: All, ages: 25 Years to 45 Years, accepts healthy volunteers

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.

+Locations (2)

FacilityCityCountryStatus
NanMoFang Community Health Service CenterChaoYang District, Beijing MunicipalityChina
JuQuan Community Health Service CenterGucun, Baoshan District,, Shanghai MunicipalityChina

+Investigators

  • Ying An, Ph.D, Study director, Inner Mongolia Hilo Industrial Group Co., Ltd
  • Donglian Cai, Principal investigator, Changhai Hospital of Shanghai, Nutriology Dept.
  • Xinwang Gao, Principal investigator, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine Dept..

My Notes