ConstipationPhase 1/2NCT02091115
Consumption of Milk Drink and Constipation
A Phase 1/2 study testing dairy drink with probiotic culture and Dairy drink in people with Constipation, run by Centro Universitário Univates at 1 site in Brazil.
Trial summary
Constipation is a disorder which can be associated with various pathologies or could also be an effect of the consumption of drugs, improper diet and life style. Is increasingly common the utilization of probiotics in foods. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- dairy drink with probiotic culture and Dairy drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Sep 2013
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women
Who cannot join
- diabetic women,
- pregnant,
- breastfeeding women,
- gastrointestinal symptoms,
- gastrointestinal pathologies preliminary,
- current or recent use of antibiotics, antiinflammatory or other drugs,
Show all 12Show fewer
- womens with pathologies that alter the bowel habits,
- food allergies and intolerances,
- ulcerative colitis,
- Crohn's disease and irritable bowel syndrome,
- patients having lactose intolerance or do not like milk drink,
- patients showing them to use other types of probiotic food, prebiotic and symbiotic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Consumption of Milk Drink With Bifidobacterium Animalis in Symptoms of Constipation.
Constipation is a disorder which can be associated with various pathologies or could also be an effect of the consumption of drugs, improper diet and life style. Is increasingly common the utilization of probiotics in foods. Probiotics are defined as live microorganisms administered in adequate amounts confer a health benefit to the host, the most widely used for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective of the present study is to assess the effectiveness of the consumption of dairy beverage enriched with probiotic for the treatment of the symptoms of constipation.
Read the detailed description
To that randomized clinical trial, double blind controlled, were recruited in the city of Teutônia - RS - Brazil, 49 women aged 20-50 years. Patients with pathologies that alter the bowel habits, such as food allergies and intolerances; diabetic women, pregnant, breastfeeding women, gastrointestinal symptoms, gastrointestinal pathologies preliminary, current or recent use of antibiotics, anti-inflammatory, laxatives or other drugs were excluded. Ulcerative colitis, Crohn's disease and irritable bowel syndrome, patients having lactose intolerance or do not like milk drink, besides patients showing them to use other types of probiotic food, prebiotic and symbiotic.
Study participants have been diagnosed with constipation according to the recommendations established by the Rome III criteria (World Gastroenterology Organization) and the Bristol Scale (World Gastroenterology Organization). Answered to a questionnaire on the general data, with questions related to the consumption of fruits and vegetables, meats, milk products, water intake, alcohol intake, smoking and physical activity practice.
Were randomly divided in two groups, one group received probiotic culture dairy drink (intervention group), animalis bifidobacterium, containing 3.2 x 107 and the other group has received dairy drink (control group). Was directed towards participants the consumption of one cup (150 ml) of dairy drink per day, preferably on an empty stomach or morning snack, during period of 60 days. The dairy beverages have been donated by a company, bottled in 1 liter bottles, transported in appropriate thermal boxes and delivered in three stages, every twenty days in the residence of the participants.
After 60 consumption days of dairy beverage new reviews with the participants were conducted, they are nutritional assessment and implemented the Rome III Criteria and Scale Bristol again. To do this the weight, height, waist and hip circumference were measured. To measure was utilized digital balance with capacity of 300 kg and inelastic tape with an extension of 1.5 m. Was recommended for participants to stay barefoot and use light clothing. Thereafter, we calculated the Body Mass Index (BMI), waist-hip ratio and risk for cardiovascular disease, classified according to the parameters established by the World Health Organization (1998).
The guidelines on how consume and storing the dairy drink were provided to the participants before the distribution of products. A dairy beverage should be consumed every day preferentially in the morning, be agitated before consuming, not heat it, stored refrigerated. During the study period, participants were instructed not to change their eating habits, physical activity practice, fluid intake and not make use of other products with probiotic culture.
Quantitative variables were described using mean and standard deviation or median and interquartile range. Categorical variables were described by absolute and relative frequencies. To compare means between groups, Student's t-test for independent samples was applied. In case of asymmetry, the Mann-Whitney test was used. To compare proportions, the chi-square test was applied. To evaluate the ROME III and Bristol-scale pre-and post-intervention, the Wilcoxon test was applied. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 18.0. The level of statistical significance was 5% (p ≤ 0.05).
- Conditions
- Constipation
- Being tested
- dairy drink with probiotic culture, Dairy drink
- Keywords
- Constipation, ROMA III criteria, Scale Bristol
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dairy drink with probiotic cultureDietary supplement
The participants were instructed to consume the dairy drink with probiotic culture containing animalis bifidobacterium with 3.2 x 107 UFC for 60 days and a glass of 150 ml daily.
Dairy drinkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Dairy drink | Placebo comparator | Patients received dairy drink for 60 days and were instructed to consume a glass of 150 mL daily. Receives: Dietary Supplement: Dairy drink |
| Dairy drink with probiotic culture | Active comparator | Patients received dairy drink with probiotic culture for 60 days and were instructed to consume a glass of 150 mL daily. Receives: Dietary Supplement: dairy drink with probiotic culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in symptoms of constipation
First application of Rome III criteria and Scale Bristol in July 2013. And the second measure has occurred after the consumption of dairy drink for 60 days and was held in September 2013.
Measured: Up to two months
Secondary outcomes (1)
Increase in frequency evacuations
The frequency evacuations have been questions to participants in July 2013 and after the consumption of dairy drink in September 2013
Measured: Up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionSep 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 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
- Investigators
- Thaís R Moreira, Professor, Principal investigator, University Center Univates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091115
- Sponsor's protocol ID
- 072013
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Consumption of Milk Drink With Bifidobacterium Animalis in Symptoms of Constipation.
- ClinicalTrials.gov ID
- NCT02091115
- Acronym / sponsor ID
- 072013
- Conditions
- Constipation
- Keywords
- Constipation, ROMA III criteria, Scale Bristol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centro Universitário UnivatesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Mar 2014 (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 a disorder which can be associated with various pathologies or could also be an effect of the consumption of drugs, improper diet and life style. Is increasingly common the utilization of probiotics in foods. Probiotics are defined as live microorganisms administered in adequate amounts confer a health benefit to the host, the most widely used for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective of the present study is to assess the effectiveness of the consumption of dairy beverage enriched with probiotic for the treatment of the symptoms of constipation.
Detailed description
To that randomized clinical trial, double blind controlled, were recruited in the city of Teutônia - RS - Brazil, 49 women aged 20-50 years. Patients with pathologies that alter the bowel habits, such as food allergies and intolerances; diabetic women, pregnant, breastfeeding women, gastrointestinal symptoms, gastrointestinal pathologies preliminary, current or recent use of antibiotics, anti-inflammatory, laxatives or other drugs were excluded. Ulcerative colitis, Crohn's disease and irritable bowel syndrome, patients having lactose intolerance or do not like milk drink, besides patients showing them to use other types of probiotic food, prebiotic and symbiotic.
Study participants have been diagnosed with constipation according to the recommendations established by the Rome III criteria (World Gastroenterology Organization) and the Bristol Scale (World Gastroenterology Organization). Answered to a questionnaire on the general data, with questions related to the consumption of fruits and vegetables, meats, milk products, water intake, alcohol intake, smoking and physical activity practice.
Were randomly divided in two groups, one group received probiotic culture dairy drink (intervention group), animalis bifidobacterium, containing 3.2 x 107 and the other group has received dairy drink (control group). Was directed towards participants the consumption of one cup (150 ml) of dairy drink per day, preferably on an empty stomach or morning snack, during period of 60 days. The dairy beverages have been donated by a company, bottled in 1 liter bottles, transported in appropriate thermal boxes and delivered in three stages, every twenty days in the residence of the participants.
After 60 consumption days of dairy beverage new reviews with the participants were conducted, they are nutritional assessment and implemented the Rome III Criteria and Scale Bristol again. To do this the weight, height, waist and hip circumference were measured. To measure was utilized digital balance with capacity of 300 kg and inelastic tape with an extension of 1.5 m. Was recommended for participants to stay barefoot and use light clothing. Thereafter, we calculated the Body Mass Index (BMI), waist-hip ratio and risk for cardiovascular disease, classified according to the parameters established by the World Health Organization (1998).
The guidelines on how consume and storing the dairy drink were provided to the participants before the distribution of products. A dairy beverage should be consumed every day preferentially in the morning, be agitated before consuming, not heat it, stored refrigerated. During the study period, participants were instructed not to change their eating habits, physical activity practice, fluid intake and not make use of other products with probiotic culture.
Quantitative variables were described using mean and standard deviation or median and interquartile range. Categorical variables were described by absolute and relative frequencies. To compare means between groups, Student's t-test for independent samples was applied. In case of asymmetry, the Mann-Whitney test was used. To compare proportions, the chi-square test was applied. To evaluate the ROME III and Bristol-scale pre-and post-intervention, the Wilcoxon test was applied. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 18.0. The level of statistical significance was 5% (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy drink | Placebo comparator | Dietary Supplement: Dairy drinkPatients received dairy drink for 60 days and were instructed to consume a glass of 150 mL daily. |
| Dairy drink with probiotic culture | Active comparator | Dietary Supplement: dairy drink with probiotic culturePatients received dairy drink with probiotic culture for 60 days and were instructed to consume a glass of 150 mL daily. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women
Key exclusion criteria (12 listed)
- diabetic women,
- pregnant,
- breastfeeding women,
- gastrointestinal symptoms,
- gastrointestinal pathologies preliminary,
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 |
|---|---|---|
| dairy drink with probiotic cultureThe participants were instructed to consume the dairy drink with probiotic culture containing animalis bifidobacterium with 3.2 x 107 UFC for 60 days and a glass of 150 ml daily. | Dietary supplement | Dairy drink with probiotic culture |
| Dairy drink | Dietary supplement | Dairy drink |
Primary outcome
Decrease in symptoms of constipation
Time frame: Up to two months
First application of Rome III criteria and Scale Bristol in July 2013. And the second measure has occurred after the consumption of dairy drink for 60 days and was held in September 2013.
1 secondary outcome
Increase in frequency evacuations
Time frame: Up to two months
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 19 Mar 2014.
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.
Thaís R Moreira, Professor principal investigator
University Center Univates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dairy drink with probiotic culture and Dairy drink in people with Constipation, run by Centro Universitário Univates at 1 site in Brazil.
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 1 inclusion and 12 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 19 Mar 2014. 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Decrease in symptoms of constipation (time frame: Up to two months). 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 19 Mar 2014.