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

Not Applicable

Completed

• Conditions: Constipation; Dyspepsia; Flatulence; Abdominal Pain
• Interventions: Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1); Dietary Supplement: Placebo yoghurt; Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)

• Registration Number: NCT01682798
• Lead Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)	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 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)	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.

Primary Outcome Measures

Name	Time	Method
Change in constipation condition after 3 weeks	Baseline & 3 weeks

Secondary Outcome Measures

Name	Time	Method
Change in gut resident flora after 3 weeks	Baseline & 3 Weeks

Trial Locations

Locations (2)

NanMoFang Community Health Service Center; 🇨🇳 ChaoYang District, Beijing, China

JuQuan Community Health Service Center; 🇨🇳 Gucun, Baoshan District,, Shanghai, China