AzTrials
AzTrials

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.

Completed

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

Official record
Search all trials

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.

Brazil1 site
  • University Center Univates

    Lajeado, Rio Grande do Sul, 95900-000

Other trials in Brazil

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 groups in NCT02091115
Study groupRoleWhat they receive
Dairy drinkPlacebo comparatorPatients 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 cultureActive comparatorPatients 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.

  1. 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)
  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.

  1. First posted19 Mar 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2013
  4. Study completionSep 2013

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in