Periampullary Carcinoma NosPhase 3NCT01468779
Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms
A Phase 3 study testing Probiotics and Sugar pill in people with Periampullary Carcinoma Nos, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periampullary Carcinoma Nos
- What is being tested?
- Probiotics and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Apr 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in need of surgery for periampullary cancer
Who cannot join
- Patients submitted to periampullary surgery without pathologic confirmation of cancer
- Patients unwilling to be a part of the trial
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.
- Conditions
- Periampullary Carcinoma Nos
- Being tested
- Probiotics, Sugar pill
- Keywords
- Periampullary cancer, Surgery, Dietary supplementation, Nutritional assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
The probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery.
Sugar pillDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | The patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period. Receives: Dietary Supplement: Sugar pill |
| Probiotics | Active comparator | The probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery. Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period
Measured: participants will be followed for the duration of hospital stay, an expected average of 15 days
Secondary outcomes (1)
Postoperative infection rate
To assess postoperative infection rate in patients submitted to periampullary cancer surgery using probiotics.
Measured: participants will be followed for the duration of hospital stay, an expected average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary Carcinoma NosStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Heloisa Sommacal, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468779
- Sponsor's protocol ID
- 09256
- Other IDs
- HCPA09256
- Status last verified
- Mar 2017
- First submitted
- 3 Aug 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01468779
- Acronym / sponsor ID
- 09256
- Conditions
- Periampullary Carcinoma Nos
- Keywords
- Periampullary cancer, Surgery, Dietary supplementation, Nutritional assessment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Nov 2011 (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 evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Dietary Supplement: Sugar pillThe patients submitted to periampullary cancer surgery will receive sugar pills in the preoperative and postoperative period. |
| Probiotics | Active comparator | Dietary Supplement: ProbioticsThe probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in need of surgery for periampullary cancer
Key exclusion criteria (2 listed)
- Patients submitted to periampullary surgery without pathologic confirmation of cancer
- Patients unwilling to be a part of the trial
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 |
|---|---|---|
| ProbioticsThe probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery. | Dietary supplement | Probiotics |
| Sugar pill | Dietary supplement | Sugar pill |
Primary outcome
Mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 15 days
Death will be considered as the primary outcome related to complications of surgical treatment in postoperative period
1 secondary outcome
Postoperative infection rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 15 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 3 Mar 2017.
- Related InfoLink provided by the sponsor.
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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 and Sugar pill in people with Periampullary Carcinoma Nos, run by Hospital de Clinicas de Porto Alegre 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 2 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 3 Mar 2017. 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 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?
Mortality (time frame: participants will be followed for the duration of hospital stay, an expected average of 15 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 3 Mar 2017.