The Clinical Research on the Efficiency of Yili "Changqing" Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System
| Registry | NCT01682798 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 400 (Actual) |
| Sponsor | Inner Mongolia Yili Industrial Group Co., Ltd (Industry) |
| Conditions | Constipation, Dyspepsia, Flatulence, Abdominal Pain |
| Interventions | Placebo yoghurt, Yili "Chang Qing" Pro-ABB yoghurt (Formula 1), Yili "Chang Qing" Pro-ABB yoghurt (Formula 2) (Dietary supplement) |
| Dates | start 2009-05-01, primary completion 2009-06-01, completion 2009-07-01, first posted 2012-09-11, last updated 2012-10-25 |
| Locations | 2 sites in China |
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All trials for Constipation All trials for Dyspepsia All trials of Placebo yoghurt All trials of Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Yili "Chang Qing" Pro-ABB yoghurt (Formula 1) | Active comparator | Dietary 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 yoghurt | Placebo comparator | Dietary Supplement: Placebo yoghurt | 100g 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 comparator | Dietary 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. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| NanMoFang Community Health Service Center | ChaoYang District, Beijing Municipality | China | |
| JuQuan Community Health Service Center | Gucun, Baoshan District,, Shanghai Municipality | China |