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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682798
• Other study ID #: YL/LC-001
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: October 24, 2012
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: October 2012
• Source: Inner Mongolia Yili Industrial Group Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Pain
• Constipation
• Dyspepsia
• Flatulence

Intervention

Dietary Supplement:
• Placebo yoghurt
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)
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)

Locations

Country	Name	City	State
China	NanMoFang Community Health Service Center	ChaoYang District	Beijing
China	JuQuan Community Health Service Center	Gucun, Baoshan District,	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Inner Mongolia Yili Industrial Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in constipation condition after 3 weeks		Baseline & 3 weeks	No
Secondary	Change in gut resident flora after 3 weeks		Baseline & 3 Weeks	No