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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Constipation, Dyspepsia, Flatulence, Abdominal Pain

Intervention / Treatment
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* Dietary Supplement: Placebo yoghurt
* Dietary Supplement: Yili Chang Qing Pro-ABB yoghurt (Formula 1)
* Dietary Supplement: Yili Chang Qing Pro-ABB yoghurt (Formula 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 25-45 yrs; Non-specific and/or moderate constipation; Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain); 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: Diagnosed as chronic constipation; Treated gastrointestinal symptoms; Lactose Intolerance; Treatment by analgesic such as aspirin and paracetamol; Had laxatives or other remedies to promote digestion 2 weeks prior to the study start; Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start; Currently suffering from diarrhea.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yili Chang Qing Pro-ABB yoghurt (Formula 1)<br>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)<br>* 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.<br>|
| Placebo Comparator: Placebo yoghurt<br>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<br>* 100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.<br>|
| Active Comparator: Yili Chang Qing Pro-ABB yoghurt (Formula 2)<br>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)<br> <br> * 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in constipation condition after 3 weeks |  | Baseline & 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut resident flora after 3 weeks |  | Baseline & 3 Weeks |