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

NCT ID: NCT01682798

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-07-31

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.

Detailed Description

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Conditions

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Constipation Dyspepsia Flatulence Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo yoghurt

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

Group Type PLACEBO_COMPARATOR

Placebo yoghurt

Intervention Type DIETARY_SUPPLEMENT

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 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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo yoghurt

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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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.

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inner Mongolia Yili Industrial Group Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying An, Ph.D

Role: STUDY_DIRECTOR

Inner Mongolia Hilo Industrial Group Co., Ltd

Donglian Cai

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital of Shanghai, Nutriology Dept.

Xinwang Gao

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Geriatric Medicine Dept..

Locations

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NanMoFang Community Health Service Center

ChaoYang District, Beijing Municipality, China

Site Status

JuQuan Community Health Service Center

Gucun, Baoshan District,, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YL/LC-001

Identifier Type: -

Identifier Source: org_study_id