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

Inner Mongolia Yili Industrial Group

Status: Completed

Conditions: Flatulence; Dyspepsia; Constipation; Abdominal Pain

Treatments: Dietary Supplement: Placebo yoghurt; Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2); Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682798

YL/LC-001

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 3 patient groups, including a placebo group

Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)

Placebo yoghurt

Placebo Comparator group

Description:

100g of placebo yoghurt (normal yoghurt) will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.

Treatment:

Dietary Supplement: Placebo yoghurt

Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)