NCT01682798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

1 month

First QC Date

August 23, 2012

Last Update Submit

October 24, 2012

Conditions

ConstipationDyspepsiaFlatulenceAbdominal Pain

Outcome Measures

Primary Outcomes (1)

  • Change in constipation condition after 3 weeks

    Baseline & 3 weeks

Secondary Outcomes (1)

  • Change in gut resident flora after 3 weeks

    Baseline & 3 Weeks

Study Arms (3)

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

ACTIVE COMPARATOR

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.

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

Placebo yoghurt

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo yoghurt

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

ACTIVE COMPARATOR

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.

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

Interventions

Placebo yoghurtDIETARY_SUPPLEMENT

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

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

Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)DIETARY_SUPPLEMENT
Also known as: 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)

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NanMoFang Community Health Service Center

ChaoYang District, Beijing Municipality, China

Location

JuQuan Community Health Service Center

Gucun, Baoshan District,, Shanghai Municipality, China

Location

MeSH Terms

Conditions

ConstipationDyspepsiaFlatulenceAbdominal Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Ying An, Ph.D

    Inner Mongolia Hilo Industrial Group Co., Ltd

    STUDY DIRECTOR

  • Donglian Cai

    Changhai Hospital of Shanghai, Nutriology Dept.

    PRINCIPAL INVESTIGATOR

  • Xinwang Gao

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 11, 2012

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

CN(2)