ConstipationPhase 3NCT01161784
The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
A Phase 3 study testing Probiotics fermented milk and Nutrient drink in people with Constipation, run by IMU University, Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotics fermented milk and Nutrient drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2010to Jun 2010
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with functional constipation based on ROME II criteria
- Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
- Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
- Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period
Who cannot join
- Body Mass Index of less than 16, or 30 and above
- Pregnant
- Regular ingestion of probiotic products within the preceding four weeks
- Regular use of laxatives (average once a week or more)
- Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
- Persons with milk protein allergy
- Persons with constipation of organic or neurological origin based on health screening
- Persons with alarm features as assessed by physician during health screening
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
International Medical University
Kuala Lumpur, Kuala Lumpur, 57000
About this study
The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.
- Conditions
- Constipation
- Being tested
- Probiotics fermented milk, Nutrient drink
- Keywords
- Functional constipation, Probiotic, Probiotic microorganism, Lactobacillus casei Shirota (LcS)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics fermented milkDietary supplement
80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
Nutrient drinkDietary supplement
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nutrient drink | Placebo comparator | Not described Receives: Dietary Supplement: Nutrient drink |
| Probiotics | Experimental | Not described Receives: Dietary Supplement: Probiotics fermented milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation:
- Severity of false alarms
- Frequency of less than 3 defecations / week
- Severity of sensation of incomplete bowel movement
- Severity of lumpy or hard stools
- Severity of bloating
- Frequency of laxative use
Measured: 4 weeks
Frequency of bowel movement
Measured: 4 weeks
Secondary outcomes (2)
Stool consistency based on modified Bristol Stool scale
Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5.
Measured: 4 weeks
Stool output quantity estimations
Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMU University, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161784
- Sponsor's protocol ID
- IMU RO52/2009
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
- ClinicalTrials.gov ID
- NCT01161784
- Acronym / sponsor ID
- IMU RO52/2009
- Conditions
- Constipation
- Keywords
- Functional constipation, Probiotic, Probiotic microorganism, Lactobacillus casei Shirota (LcS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IMU University, MalaysiaUniversity, hospital or other
- Collaborators
- University of Malaya, National University of Malaysia
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Jul 2010 (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 the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrient drink | Placebo comparator | Dietary Supplement: Nutrient drink |
| Probiotics | Experimental | Dietary Supplement: Probiotics fermented milk |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with functional constipation based on ROME II criteria
- Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
- Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
- Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period
Key exclusion criteria (8 listed)
- Body Mass Index of less than 16, or 30 and above
- Pregnant
- Regular ingestion of probiotic products within the preceding four weeks
- Regular use of laxatives (average once a week or more)
- Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
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 |
|---|---|---|
| Probiotics fermented milk80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks | Dietary supplement | Probiotics |
| Nutrient drink80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks | Dietary supplement | Nutrient drink |
Primary outcome
Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)
Time frame: 4 weeks
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation: 1. Severity of false alarms 2. Frequency of less than 3 defecations / week 3. Severity of sensation of incomplete bowel movement 4. Severity of lumpy or hard stools 5. Severity of bloating 6. Frequency of laxative use
Frequency of bowel movement
Time frame: 4 weeks
2 secondary outcomes
Stool consistency based on modified Bristol Stool scale
Time frame: 4 weeks
Stool output quantity estimations
Time frame: 4 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 14 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotics fermented milk and Nutrient drink in people with Constipation, run by IMU University, Malaysia at 1 site in Malaysia.
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 8 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 14 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2010; AzTrials last refreshed its copy on 6 Nov 2026.