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

Primary Purpose

Constipation, Dyspepsia, Flatulence

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Placebo yoghurt

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

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

About this trial

This is an interventional prevention trial for Constipation

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female subjects, 25-45 yrs;
Non-specific and/or moderate constipation;
Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
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:

Diagnosed as chronic constipation;
Treated gastrointestinal symptoms;
Lactose Intolerance;
Treatment by analgesic such as aspirin and paracetamol;
Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
Currently suffering from diarrhea.

Sites / Locations

NanMoFang Community Health Service Center
JuQuan Community Health Service Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

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

Placebo yoghurt

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

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

Change in constipation condition after 3 weeks

Secondary Outcome Measures

Change in gut resident flora after 3 weeks

Full Information

NCT ID

NCT01682798

First Posted

August 23, 2012

Last Updated

October 24, 2012

Sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01682798

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation, Dyspepsia, Flatulence, Abdominal Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo yoghurt

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo yoghurt

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Other Intervention Name(s)

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.

Primary Outcome Measure Information:

Title

Change in constipation condition after 3 weeks

Time Frame

Baseline & 3 weeks

Secondary Outcome Measure Information:

Title

Change in gut resident flora after 3 weeks

Time Frame

Baseline & 3 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects, 25-45 yrs; Non-specific and/or moderate constipation; Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain); 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: Diagnosed as chronic constipation; Treated gastrointestinal symptoms; Lactose Intolerance; Treatment by analgesic such as aspirin and paracetamol; Had laxatives or other remedies to promote digestion 2 weeks prior to the study start; Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start; Currently suffering from diarrhea.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying An, Ph.D

Organizational Affiliation

Inner Mongolia Hilo Industrial Group Co., Ltd

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Donglian Cai

Organizational Affiliation

Changhai Hospital of Shanghai, Nutriology Dept.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xinwang Gao

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

NanMoFang Community Health Service Center

City

ChaoYang District

State/Province

Beijing

Country

China

Facility Name

JuQuan Community Health Service Center

City

Gucun, Baoshan District,

State/Province

Shanghai

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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