Completed
The Clinical Research on the Efficiency of Yili "Changqing" Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System
What is being tested
Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
+ Placebo yoghurt
+ Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
Dietary Supplement
Who is being recruted
Neurologic Manifestations+6
+ Pain
+ Signs and Symptoms
From 25 to 45 Years
+11 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-Controlled
Interventional
Study Start: May 2009
Summary
Principal SponsorInner Mongolia Yili Industrial Group Co., Ltd
Last updated: October 25, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2009
Actual date on which the first participant was enrolled.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.
Principal SponsorInner Mongolia Yili Industrial Group Co., Ltd
Last updated: October 25, 2012
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 25 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neurologic ManifestationsPainSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsConstipationDyspepsiaFlatulenceAbdominal Pain
Criteria
4 inclusion criteria required to participate
Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain)
Male or female subjects, 25-45 yrs
Non-specific and/or moderate constipation
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)
7 exclusion criteria prevent from participating
Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start
Currently suffering from diarrhea
Diagnosed as chronic constipation
Had laxatives or other remedies to promote digestion 2 weeks prior to the study start
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active Comparator100g 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 II
Placebo100g of placebo yoghurt (normal yoghurt) will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
Group III
Active Comparator100g 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
NanMoFang Community Health Service Center
ChaoYang District, ChinaOpen NanMoFang Community Health Service Center in Google MapsJuQuan Community Health Service Center
Gucun, Baoshan District,, ChinaCompleted2 Study Centers