ConstipationNCT02446080
Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation
A study testing Milk drink with probiotic culture and Milk drink in people with Constipation, run by Centro Universitário Univates.
Trial summary
Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in consumption of products containing… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Milk drink with probiotic culture and Milk drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2015
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a diagnosis of constipation;
- Have aged between 20 and 50 years;
- Being female.
Who cannot join
- Patients with diabetes;
- Patients pregnant and lactating women;
- Patients with diarrhea, with previous gastrointestinal disorders;
- Current or recent consumption of antibiotics, anti-inflammatory drugs, laxatives or other drugs;
- Patients with diseases that alter bowel habits, such as food allergies and intolerances, ulcerative colitis, chron's disease and irritable bowel syndrome.
- Patients who have lactose intolerance or dislike of milk drink.
About this study
Official title: The Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation Women
Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in consumption of products containing fiber, intake of drugs or laxatives, decreased intestinal motility and physical inactivity. The objective was to evaluate the effect of consumption of dairy products with probiotics on constipation. Randomized double-blind clinical trial in the city of Bom Retiro do Sul / RS, Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack.
Read the detailed description
Randomized double blind clinical trial conducted at the health center of the city of Bom Retiro do Sul / RS, Brazil, from December 2014 to March 2015. The study began after approval by the Ethics Committee of the Research Center University Univates (COEP), Lajeado. Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack. The milk drink was provided in the homes of participants and the health center of the city of Bom Retiro do Sul once a week. At the beginning of treatment and at the end of treatment that will last 60 days, will be delivered to Bristol Scale and the criteria of Rome III, so as to verify the improvement or not of constipation. Patients who agree to participate in the study signed a consent form IC. Will be the orientation for the volunteers not to consume yogurt and other cultured milks with probiotics, will also be oriented to maintain the same diet and lifestyle when they were constipated, thus, check for improvement in constipation with the use of probiotics .
Inclusion criteria: Having a diagnosis of constipation; Be aged between 20 and 50 years; being female.
Data collection brings no risk or damage to entrant, but can cause discomfort and embarrassment to meet the criteria of Rome III and Bristol Scale and the time that will have to spend 10 to 15 minutes. Such issues will be mitigated by the fact that the interview be individualized and the participant have at their disposal a private room to answer the questionnaires, only with the presence of the academic.
Participants will not obtain any financial benefit, only the benefits of milk drink with probiotics and how much consumption adds to your health. It is also important to note that participation in the study will not result in expenses.
- Conditions
- Constipation
- Being tested
- Milk drink with probiotic culture, Milk drink
- Keywords
- Constipation, Probiotics, Women
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk drink with probiotic cultureDietary supplement
The Probiotc group was asked to drink 150 ml per day of dairy drinks with probiotic culture
Milk drinkDietary supplement
The control group was asked to drink 150 ml per day of dairy drinks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Milk drink with probiotic culture (150 mL/daily) for 60 days. Receives: Dietary Supplement: Milk drink with probiotic culture |
| Control Group | Active comparator | Milk drink (150 mL/daily) for 60 days. Receives: Dietary Supplement: Milk drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms of constipation
Improvement of symptoms of constipation by ROME III criteria and Bristol scale.
Measured: 60 days
Secondary outcomes (1)
Increased number of bowel movements
Increased number of bowel movements per week and is quoted by ROME III criteria.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
- Study completionMar 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Univates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thaís Rodrigues Moreira, Centro Universitário Univates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446080
- Sponsor's protocol ID
- CUUnivates
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation Women
- ClinicalTrials.gov ID
- NCT02446080
- Acronym / sponsor ID
- CUUnivates
- Conditions
- Constipation
- Keywords
- Constipation, Probiotics, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Universitário UnivatesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 May 2015 (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.
Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in consumption of products containing fiber, intake of drugs or laxatives, decreased intestinal motility and physical inactivity. The objective was to evaluate the effect of consumption of dairy products with probiotics on constipation. Randomized double-blind clinical trial in the city of Bom Retiro do Sul / RS, Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack.
Detailed description
Randomized double blind clinical trial conducted at the health center of the city of Bom Retiro do Sul / RS, Brazil, from December 2014 to March 2015. The study began after approval by the Ethics Committee of the Research Center University Univates (COEP), Lajeado. Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack. The milk drink was provided in the homes of participants and the health center of the city of Bom Retiro do Sul once a week. At the beginning of treatment and at the end of treatment that will last 60 days, will be delivered to Bristol Scale and the criteria of Rome III, so as to verify the improvement or not of constipation. Patients who agree to participate in the study signed a consent form IC. Will be the orientation for the volunteers not to consume yogurt and other cultured milks with probiotics, will also be oriented to maintain the same diet and lifestyle when they were constipated, thus, check for improvement in constipation with the use of probiotics .
Inclusion criteria: Having a diagnosis of constipation; Be aged between 20 and 50 years; being female.
Data collection brings no risk or damage to entrant, but can cause discomfort and embarrassment to meet the criteria of Rome III and Bristol Scale and the time that will have to spend 10 to 15 minutes. Such issues will be mitigated by the fact that the interview be individualized and the participant have at their disposal a private room to answer the questionnaires, only with the presence of the academic.
Participants will not obtain any financial benefit, only the benefits of milk drink with probiotics and how much consumption adds to your health. It is also important to note that participation in the study will not result in expenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: Milk drink with probiotic cultureMilk drink with probiotic culture (150 mL/daily) for 60 days. |
| Control Group | Active comparator | Dietary Supplement: Milk drinkMilk drink (150 mL/daily) for 60 days. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having a diagnosis of constipation;
- Have aged between 20 and 50 years;
- Being female.
Key exclusion criteria (6 listed)
- Patients with diabetes;
- Patients pregnant and lactating women;
- Patients with diarrhea, with previous gastrointestinal disorders;
- Current or recent consumption of antibiotics, anti-inflammatory drugs, laxatives or other drugs;
- Patients with diseases that alter bowel habits, such as food allergies and intolerances, ulcerative colitis, chron's disease and irritable bowel syndrome.
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 |
|---|---|---|
| Milk drink with probiotic cultureThe Probiotc group was asked to drink 150 ml per day of dairy drinks with probiotic culture | Dietary supplement | Probiotic Group |
| Milk drinkThe control group was asked to drink 150 ml per day of dairy drinks. | Dietary supplement | Control Group |
Primary outcome
Improvement of symptoms of constipation
Time frame: 60 days
Improvement of symptoms of constipation by ROME III criteria and Bristol scale.
1 secondary outcome
Increased number of bowel movements
Time frame: 60 days
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 15 May 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Milk drink with probiotic culture and Milk drink in people with Constipation, run by Centro Universitário Univates.
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 3 inclusion and 6 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Improvement of symptoms of constipation (time frame: 60 days). 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 15 May 2015.