ConstipationNCT01682798

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

A study testing Yili "Chang Qing" Pro-ABB yoghurt (Formula 1) and Yili "Chang Qing" Pro-ABB yoghurt (Formula 2) in people with Constipation and Dyspepsia, run by Inner Mongolia Yili Industrial Group Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Constipation, Dyspepsia, Flatulence
What is being tested?: Yili "Chang Qing" Pro-ABB yoghurt (Formula 1) and Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 400 participants
Where: 2 sitesChina
Study dates: May 2009to Jul 2009
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

NanMoFang Community Health Service Center
ChaoYang District, Beijing Municipality
JuQuan Community Health Service Center
Gucun, Baoshan District,, Shanghai Municipality

Other trials in China

About this study

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

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.

Conditions: Constipation, Dyspepsia, Flatulence, Abdominal Pain
Being tested: Placebo yoghurt, Yili "Chang Qing" Pro-ABB yoghurt (Formula 1), Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)
Medical subject headings: Constipation, Dyspepsia, Flatulence, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo yoghurtDietary 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 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 2)Dietary supplement
Also called 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.

Study groups in NCT01682798
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in constipation condition after 3 weeks
Measured: Baseline & 3 weeks

Secondary outcomes (1)

Change in gut resident flora after 3 weeks
Measured: Baseline & 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Jul 2009

First posted11 Sep 2012 (estimated)
Study startMay 2009
Primary completionJun 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682798
Sponsor's protocol ID: YL/LC-001
Status last verified: Oct 2012
First submitted: 23 Aug 2012
Last updated: 25 Oct 2012
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Research on the Efficiency of Yili "Changqing" Pro-ABB Probiotic Yogurt in the Improvement of Human Gastrointestinal Tract System
ClinicalTrials.gov ID: NCT01682798
Acronym / sponsor ID: YL/LC-001
Conditions: Constipation, Dyspepsia, Flatulence, Abdominal Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Inner Mongolia Yili Industrial Group Co., LtdIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Jun 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)	Active comparator	Dietary Supplement: 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.
Placebo yoghurt	Placebo comparator	Dietary Supplement: Placebo yoghurt100g of placebo yoghurt (normal 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)	Active comparator	Dietary Supplement: 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.

Who may qualify

Ages: 25 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo yoghurt100g of placebo 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 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.	Dietary supplement	Yili "Chang Qing" Pro-ABB yoghurt (Formula 1)
Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)Also: 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.	Dietary supplement	Yili "Chang Qing" Pro-ABB yoghurt (Formula 2)

Primary outcome

Change in constipation condition after 3 weeks
Time frame: Baseline & 3 weeks

1 secondary outcome

Change in gut resident flora after 3 weeks
Time frame: Baseline & 3 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ying An, Ph.D study director

Inner Mongolia Hilo Industrial Group Co., Ltd

Donglian Cai principal investigator

Changhai Hospital of Shanghai, Nutriology Dept.

Xinwang Gao principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in constipation condition after 3 weeks (time frame: Baseline & 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01682798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.