ConstipationNCT01680432
Effect of the Consumption of a Cheese Enriched With Probiotic Organisms in Improving Symptoms of Constipation
A study testing Probiotic fresh cheese and Regular Cheese in people with Constipation, run by Centro Universitário Univates at 1 site in Brazil.
Trial summary
Constipation is a common gastrointestinal motility disorder, chronic condition that often negatively affects the daily lives of patients due to their symptoms, such as infrequent stools, hard stools, straining or painful defecation, cramping, bloating and flatulence. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotic fresh cheese and Regular Cheese
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to May 2012
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults constipated.
Who cannot join
- Pregnant women
- Individuals who report to be suffering from other diseases of the intestine;
- Individuals who report not eat cheese, either for reasons of taste or intolerances / food allergies
- Individuals who do not agree to participate and do not sign the term of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Consumption of a Cheese Enriched With Probiotic Organisms (Bifidobacterium Lactis Bi-07) in Improving Symptoms of Constipation: a Randomized Controlled Trial
Constipation is a common gastrointestinal motility disorder, chronic condition that often negatively affects the daily lives of patients due to their symptoms, such as infrequent stools, hard stools, straining or painful defecation, cramping, bloating and flatulence. Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to the onset of constipation. One way to reduce constipation through nutritional management of affected individuals is through consumption of probiotic products, which beneficially affect the development of microbial flora in the intestine, helping to improve the symptoms of constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis, which according to its maker, when consumed as part of a healthy diet, presents beneficial effects in improving symptoms of constipation.
Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms constipation.
Read the detailed description
General Objective: To investigate the effect of consumption of fresh cheese enriched with Bifidobacterium lactis in improving symptoms of constipation.
Specific Objectives:
Determine whether the intake of cheese enriched with Bifidobacterium lactis changes:
- frequency of bowel movements;
- straining or pain when defecating;
- format of the faeces;
- sensation of incomplete evacuation;
- sensation of anorectal obstruction and
- use of manual maneuvers to facilitate evacuation.
The food industry is increasingly concerned about produce food that are healthy and able to prevent diseases, in particular, to ensure intestinal health. To verify the effectiveness of these new products on the market is one way to ensure that they have health benefits. Thus, they may be indicated as a treatment for constipation, as part of a healthy lifestyle that includes nutrition and physical activity practice. For this reason, this search is justified.
Type Search:
The research is quantitative, exploratory and experimental. This is a clinical trial randomized and controlled trial.
Population and study sample:
The study population comprised of individuals who will use the Unified Service Health System, the Family Health Strategy,Brazil, participating groups of Nutritional Education. This population is comprised of approximately seventy individuals, but this number is quite relative, it depends on the participation. The approach of research subjects will be done through an invitation, conducted orally through the Community Health Agents (CHA), during home visits monthly. During the period of one month, the CHA invite to attend a lecture given by the student Diane Favretto, who will speak constipation on the subject and propose the participation of stake holders in the research. The stakeholders respond to a questionnaire administered by the student and those who 24 showing symptoms of constipation (according to Rome III criteria), will be part of study, and the sample.
Methodology:
For individuals in the population are classified as constipated, they will responding to a structured questionnaire with closed questions based on criteria Rome III that characterizes the symptoms of constipation. Will be considered constipated individual who has at least two of six symptoms in the questionnaire, 25 at least 25% of the evacuation, in that alternative corresponds to the questionnaire "Often".
Being able to participate in this study, a structured questionnaire, with open and closed questions to assess the lifestyle (dietary habits, intake of net) associated diseases and medications will be made to collect these data.
The weight of the participant will be measured using portable scale brand and the individual is placed standing bare foot in the center of scale with light clothing, with arms out stretched to the side, with out moving. To measure the height measuring tape will be set at flat wall with no baseboard and individuals will be placed in an upright position, standing with bare feet parallel and heels, shoulders and buttocks touching the wall. The Body Mass Index is calculated from data on weight and height (kg / m²) and classified according to the Organization World Health Organization.
Both data will be collected at the neighborhood community hall, where the meetings monthly nutrition education groups are held. Agreeing to participate in the study, the group will receive all necessary instructions and will sign the informed consent. Each participant receives two copies of the word, anda copy shall be given to the student and a copy will be with the participant. Individuals selected to participate in the study will be randomized into two groups: treated group and control group. The treatment group will receive the fresh cheese plus Bifidobacterium lactis Bi-07, with 108 colony forming units per serving. In the placebo group, individuals will receive a fresh cheese, the same brand, with out the addition of probiotics. The products will be packaged or numbered so that neither the researcher nor the participants know what is cheese and what is probiotic cheese placebo. The two groups will be oriented eating a slice of cheese per day (30 grams) for 30 days. This cheese will part of the breakfast. Patients will be advised that, according to the manufacturer's product, both cheeses not present any risk to health. Some patients may not like the taste of cheese. That may be minimized by the use there of in food preparation involving other,as sandwiches and salads, as long as the cheese is not heated, because this way he loses probiotic your property. During this period, all participants will be instructed to continue their normal dietary habits, physical activity and fluid intake. It will also be directed to participants do not make use of other products containing probiotics.
After the intervention period, the questionnaire on the symptoms of constipation is applied again in order to determine whe ther there was a change in bowel habits.
- Conditions
- Constipation
- Being tested
- Probiotic fresh cheese, Regular Cheese
- Keywords
- constipation, probiotics, bifidobacterium, cheese
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic fresh cheeseDietary supplement
Also called Fresh cheese enriched with Bifidobacterium lactis Bi-07
Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.
Regular CheeseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic cheese | Experimental | The group received, for 30 days, was instructed to eat 30 g/day of probiotic fresh cheese enriched with Bifidobacterium lactis Bi-07. Receives: Dietary Supplement: Probiotic fresh cheese |
| Regular Cheese | Placebo comparator | The group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese. Receives: Dietary Supplement: Regular Cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in frequency of bowel movements after eating probiotic cheese enriched
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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, Principal investigator, University Center Univates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680432
- Sponsor's protocol ID
- 033/11
- Status last verified
- Sep 2012
- First submitted
- 6 Aug 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of a Cheese Enriched With Probiotic Organisms (Bifidobacterium Lactis Bi-07) in Improving Symptoms of Constipation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01680432
- Acronym / sponsor ID
- 033/11
- Conditions
- Constipation
- Keywords
- constipation, probiotics, bifidobacterium, cheese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centro Universitário UnivatesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 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.
Constipation is a common gastrointestinal motility disorder, chronic condition that often negatively affects the daily lives of patients due to their symptoms, such as infrequent stools, hard stools, straining or painful defecation, cramping, bloating and flatulence. Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to the onset of constipation. One way to reduce constipation through nutritional management of affected individuals is through consumption of probiotic products, which beneficially affect the development of microbial flora in the intestine, helping to improve the symptoms of constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis, which according to its maker, when consumed as part of a healthy diet, presents beneficial effects in improving symptoms of constipation.
Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms constipation.
Detailed description
General Objective: To investigate the effect of consumption of fresh cheese enriched with Bifidobacterium lactis in improving symptoms of constipation.
Specific Objectives:
Determine whether the intake of cheese enriched with Bifidobacterium lactis changes:
- frequency of bowel movements;
- straining or pain when defecating;
- format of the faeces;
- sensation of incomplete evacuation;
- sensation of anorectal obstruction and
- use of manual maneuvers to facilitate evacuation.
The food industry is increasingly concerned about produce food that are healthy and able to prevent diseases, in particular, to ensure intestinal health. To verify the effectiveness of these new products on the market is one way to ensure that they have health benefits. Thus, they may be indicated as a treatment for constipation, as part of a healthy lifestyle that includes nutrition and physical activity practice. For this reason, this search is justified.
Type Search:
The research is quantitative, exploratory and experimental. This is a clinical trial randomized and controlled trial.
Population and study sample:
The study population comprised of individuals who will use the Unified Service Health System, the Family Health Strategy,Brazil, participating groups of Nutritional Education. This population is comprised of approximately seventy individuals, but this number is quite relative, it depends on the participation. The approach of research subjects will be done through an invitation, conducted orally through the Community Health Agents (CHA), during home visits monthly. During the period of one month, the CHA invite to attend a lecture given by the student Diane Favretto, who will speak constipation on the subject and propose the participation of stake holders in the research. The stakeholders respond to a questionnaire administered by the student and those who 24 showing symptoms of constipation (according to Rome III criteria), will be part of study, and the sample.
Methodology:
For individuals in the population are classified as constipated, they will responding to a structured questionnaire with closed questions based on criteria Rome III that characterizes the symptoms of constipation. Will be considered constipated individual who has at least two of six symptoms in the questionnaire, 25 at least 25% of the evacuation, in that alternative corresponds to the questionnaire "Often".
Being able to participate in this study, a structured questionnaire, with open and closed questions to assess the lifestyle (dietary habits, intake of net) associated diseases and medications will be made to collect these data.
The weight of the participant will be measured using portable scale brand and the individual is placed standing bare foot in the center of scale with light clothing, with arms out stretched to the side, with out moving. To measure the height measuring tape will be set at flat wall with no baseboard and individuals will be placed in an upright position, standing with bare feet parallel and heels, shoulders and buttocks touching the wall. The Body Mass Index is calculated from data on weight and height (kg / m²) and classified according to the Organization World Health Organization.
Both data will be collected at the neighborhood community hall, where the meetings monthly nutrition education groups are held. Agreeing to participate in the study, the group will receive all necessary instructions and will sign the informed consent. Each participant receives two copies of the word, anda copy shall be given to the student and a copy will be with the participant. Individuals selected to participate in the study will be randomized into two groups: treated group and control group. The treatment group will receive the fresh cheese plus Bifidobacterium lactis Bi-07, with 108 colony forming units per serving. In the placebo group, individuals will receive a fresh cheese, the same brand, with out the addition of probiotics. The products will be packaged or numbered so that neither the researcher nor the participants know what is cheese and what is probiotic cheese placebo. The two groups will be oriented eating a slice of cheese per day (30 grams) for 30 days. This cheese will part of the breakfast. Patients will be advised that, according to the manufacturer's product, both cheeses not present any risk to health. Some patients may not like the taste of cheese. That may be minimized by the use there of in food preparation involving other,as sandwiches and salads, as long as the cheese is not heated, because this way he loses probiotic your property. During this period, all participants will be instructed to continue their normal dietary habits, physical activity and fluid intake. It will also be directed to participants do not make use of other products containing probiotics.
After the intervention period, the questionnaire on the symptoms of constipation is applied again in order to determine whe ther there was a change in bowel habits.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic cheese | Experimental | Dietary Supplement: Probiotic fresh cheeseThe group received, for 30 days, was instructed to eat 30 g/day of probiotic fresh cheese enriched with Bifidobacterium lactis Bi-07. |
| Regular Cheese | Placebo comparator | Dietary Supplement: Regular CheeseThe group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults constipated.
Key exclusion criteria (4 listed)
- Pregnant women
- Individuals who report to be suffering from other diseases of the intestine;
- Individuals who report not eat cheese, either for reasons of taste or intolerances / food allergies
- Individuals who do not agree to participate and do not sign the term of informed consent
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 |
|---|---|---|
| Probiotic fresh cheeseAlso: Fresh cheese enriched with Bifidobacterium lactis Bi-07Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days. | Dietary supplement | Probiotic cheese |
| Regular Cheese | Dietary supplement | Regular Cheese |
Primary outcome
Increase in frequency of bowel movements after eating probiotic cheese enriched
Time frame: 1 month
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 7 Sep 2012.
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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.
Thaís R Moreira 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 study testing Probiotic fresh cheese and Regular Cheese 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 4 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 7 Sep 2012. 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.
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?
Increase in frequency of bowel movements after eating probiotic cheese enriched (time frame: 1 month). 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 7 Sep 2012.