Colorectal CancerPhase 2NCT00936572
Probiotics In Colorectal Cancer Patients
A Phase 2 study testing Probiotics (La1, BB536) in people with Colorectal Cancer, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Probiotics (La1, BB536)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 80 years of age
- Documented cancer disease of the colorectum as diagnos pre-operatively by positive histology.
- Documented bowel disease (IBD, diverticular disease etc) as diagnosed by barium X-Ray or endoscopy.
- Elective colorectal surgery
- Surgical hospital length of stay anticipated to be at least 8 days
- Stool sample available at Day-3 pre-operatively
Show all 11Show fewer
- Receiving full enteral / oral nutrition
- Written informed consent (by subject or legal guardian)
- Both sexes with age greater than 18 years.
- Documented disease of the colorectum, candidate to major elective surgery.
- Provided written informed consent.
Who cannot join
- Perioperative unresectable tumours
- Perioperative neoplastic ascitis
- Emergency colorectal surgery
- Clinically relevant pulmonary or cardiovascular failure
- Liver failure (known cirrhosis or total bilirubin >3 mg/dl)
- Kidney failure (receiving renal dialysis or serum creatinine >2 mg/dl)
Show all 23Show fewer
- Patients receiving total parenteral nutrition (TPN)
- Immunological disorders
- Ongoing or recent infections (within last 10 days)
- Pregnant (patient's declaration)
- Participation in another clinical trial
- SUBJECT SELECTION CRITERIA
- Population Base: Patients with diagnosis of disease of the colorectum, elective for colorectal surgery
- Preoperative:
- clinically relevant failure of the pulmonary
- cardiovascular, renal or hepatic system
- ongoing bleeding
- immunological disorder
- ongoing or recent infections
- emergency surgery
- Intraoperative:
- unresectable tumors
- neoplastic ascitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Trial of Perioperative Administration of Probiotics in Colorectal Cancer Patients.
Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy.
Product:
Read more
Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30
Primary objective:
Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure)
Secondary objectives:
- Influence of the probiotic bacteria on the gut microflora
- Modulation of the immune and inflammatory response
Additional objectives:
- Investigate dose effect on La1 colonization
- Investigate the effect of La1 colonization, treatment without La1 colonization, and absence of treatment and La1 colonization on other bacteria and on immunological parameters
Read the detailed description
BACKGROUND AND RATIONALE
The administration of probiotic bacteria has been hypothesized to affect the composition of the intestinal microflora with reduction of pathogens in favour of non-pathogens. These events might modulate the immune and inflammatory responses, and the gut function.
Experimental data demonstrated that the modulation of the mucosal function and enteric microflora by Lactobacillus plantarum reduces septic morbidity and mortality in animals. The administration of a mix of probiotics has been shown to be more effective than antibiotics to cure pouchitis in humans.
Since patients undergoing colorectal operations have a high risk to develop infections due to the intraoperative contamination with enteral content and the occurence of bacterial translocation, changing the intestinal microflora, by giving lactobacilli may result in important advantages to reduce the risk of intraoperative complications and post operative sepsis.
OBJECTIVES OF THE STUDY
To evaluate if preoperative administration of mucosa reconditioning by probiotic may result in adherence to the colonic mucosa and change of the gut microflora, and may modulate the immune and inflammatory responses and gut function.
EXPERIMENTAL DESIGN AND METHODS
Overall Design and Control Methods Prospective, randomized, double-blind study design.
Centers Departement of Surgery, San Raffaele University, Milan, Italy Departement of Surgery, San Gerardo Hospital, University of Milano-Bicocca, Italy
Number of Subjects/assignment to Formula Groups In these departements about 50 patients are operated for colorectal disease yearly with laparoscopic approach. All these patients are potential candidates to partecipate in the study. It is expected that at least 80% of the patients will agree with partecipation, while during the course of the study about 25% of the partecipants are expected to withdraw. During the intake procedure the inclusion and exclusion criteria are checked. Eligible patients are informed about the objectives, the background and the design of the study. When the patient has given his or her consent to partecipate in the study, the preoperative status is assessed. The patients are then included in the study population and randomly assigned to one of the treatments. During surgery the intraoperative exclusion criteria are checked and non eligible patients excluded from further study. Each group consist of 15 patients in order to assure that at the end of the study 10 patients per group will have completed the study.
Groups:
A: high dose of probiotics (active) compared with B: low dose of probiotics (control) and C: vehicle (placebo)
Dosing Regimen ??
Dosing Scheme:
Preoperative day 5 through 1. Postoperative day 3 through 8. The three preparation will be give 3 times per day (6 hours interval).
Duration of the study 6 months
SCHEDULE OF ASSESSMENTS
Day -6 -1 0 1 2 3 4 5 6 7 8
S
I I I I I MB MB MB MB MB GF GF GF GF GF GF GF GF GF GF
S = select and inform patients I = immunological- inflammatory data MB = microbiological data GF= gastrointestinal function, fecal pH.
Immunological- inflammatory data:
DHR, lymphocyte subset (CD3, CD4, CD8, NK), IgA serum levels, CRP, IL-6, lactate.
Number and subset of intestinal lymphocytes. In vitro response of lymphocytes and macropahges to mitogens and LPS.
Microbiological data:
Quantitative and qualitative culture of stool and colonic mucosa (aerobic and anaerobic total count, aerobic gram negative and positive count)
- During surgery two mucosal samples will be collected for microscopic (adherence test) and microbiological evaluation of the presence of probiotic on the mucosa. Moreover, lymph nodes of the mesentery will harvested for microbiological analysis to assess translocation.
Intraoperative parameters:
Duration of surgery, blood loss, transfusion (amount and type), abdominal contamination.
Gastrointestinal function:
Clinical observation related to gastrointestinal symptoms and defecation pattern
Concomitant Medication and Treatments All patients will receive an antibiotic prophylaxis with cefotetan 2gr 30 minutes before surgery (single shot) and bowel preparation with iso osmotic solution and enema the day before surgery.
STUDY PARAMETERS
Efficacy
Primary Efficacy Parameters
- morphological and microbiological evaluation of the colonic microflora
- gastrointestinal function
Secondary Efficacy Parameters
- immune and inflammatory response
- bacterial translocation
Adverse event
All adverse events encountered during the study will be reported on the Case Report Form. An adverse event is any adverse change from baseline, including intercurrent illness, wich occurs during the course of the study after treatment has started, whether considered related to treatment or not.
Blinding and Randomization
The three study formulae are blinded towards each other. Both researches and patients will be blinded.
Randomization of patients into three groups is performed with the computer randomization program "Random". In this way patient numbers are assigned at random to the group "active formula", "placebo fromula" or "control formula.
Within the three groups randomization is done in blocks of 10 patientnumbers. Per study group three letters are used which are assigned at random to the patientnumbers.
The randomization list may be broken by them in case of an adverse event.
Formulation and Packaging
The formulation of the trial formulae will be in sachet
Dispensing
The investigator is responsible for storage of the study formulae during the time of the study. The sachets must be stored refrigerated until the time of handout. During the actual time that the patient takes the study formula no refrigeration of sachets is required. The investigator is responsible for the hand out of the study formulae in the order of the patientnumber.
A dispensary record of the study formula issued and of any material returned will be kept.
Preparation, Administration and Dosage of test formulae
Route
Before and after the operation the supplement is consumed orally.
Administration protocol For 5 preoperative days in addition of a free choice of hospital food, and after surgery from day 3 to 8.
Assessment of Compliance
The investigator will take high care that patients comply with the conditions set for the study, in order to prevent unnecessary withdrawal because of non compliance.
WITHDRAWAL OF SUBJECTS FROM STUDY
Subjects have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw subjects from the study in the event of intercurrent illness, adverse events, treatment failure after a prescribed procedure, protocols violation, cure, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawal can render the study uninterpretable: therefore, unnecessary, withdrawal of subjects should be avoided. Should subjects decide to withdraw, all efforts will be made to complete and report the observation as thoroughly as possible. A complete final evaluation at the time of the patient's withdrawal should be made with an explanation of why the subjects was withdrawn from the study.
If the reason for removal of a patient from the study is an adverse event or an abnormal laboratory test results, the principal specific event or test will also be recorded on the Case Report Form. In the event of an emergency when the patient's condition requires knowledge of the test treatment, the label may be opened to determine the nature of the test formula dispensed. ANY BROKEN CODE WILL BE CLEARLY JUSTIFIED AND EXPLAINED BY A COMMENT ON THE CASE REPORT FORM, along with the data on which the code was broken.
REPLACEMENT POLICY
Patients withdraw from the study will be replaced if necessary.
CRITERIA FOR EXCLUSION OF SUBJECTS' DATA FROM ANALYSES OF STUDY PARAMETERS
- Intra operative exclusion
- Extensive evidence of non compliance.
Hypothesis Testing
H0: Probiotic bacteria do not affect the microbiology of the gut mucosa and stools gastrointestinal function, immunological or inflammatory parameters compared with control or placebo.
H1: Probiotic bacteria significantly diminishes the number of adhrent and stool pathogens improves gastrointestinal function and/or immunological parameters and/or inflammatory parameters compared with control or placebo.
- Conditions
- Colorectal Cancer
- Being tested
- Probiotics (La1, BB536), placebo
- Keywords
- Probiotics, La1, BB536, Colorectal surgery, Intestinal immunity, Dendritic cells, Lymphocyte, Microbiota
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (La1, BB536)Procedure or surgery
probiotics (La1, BB536)Biological
placeboBiological
Maltodoxtrin
| Study group | Role | What they receive |
|---|---|---|
| high dose | Experimental | high dose of probiotics (109 cfu) Receives: Procedure: Probiotics (La1, BB536) |
| low dose | Experimental | low dose of probiotics (107 cfu) Receives: Biological: probiotics (La1, BB536) |
| probiotics | Placebo comparator | Maltodoxtrin Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function
Secondary outcomes (1)
Secondary Efficacy Parameters: immune and inflammatory response, bacterial translocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936572
- Sponsor's protocol ID
- 02.06.CLI
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Trial of Perioperative Administration of Probiotics in Colorectal Cancer Patients.
- ClinicalTrials.gov ID
- NCT00936572
- Acronym / sponsor ID
- 02.06.CLI
- Conditions
- Colorectal Cancer
- Keywords
- Probiotics, La1, BB536, Colorectal surgery, Intestinal immunity, Dendritic cells, Lymphocyte, Microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 10 Jul 2009 (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.
Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy.
Product:
Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30
Primary objective:
Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure)
Secondary objectives:
- Influence of the probiotic bacteria on the gut microflora
- Modulation of the immune and inflammatory response
Additional objectives:
- Investigate dose effect on La1 colonization
- Investigate the effect of La1 colonization, treatment without La1 colonization, and absence of treatment and La1 colonization on other bacteria and on immunological parameters
Detailed description
BACKGROUND AND RATIONALE
The administration of probiotic bacteria has been hypothesized to affect the composition of the intestinal microflora with reduction of pathogens in favour of non-pathogens. These events might modulate the immune and inflammatory responses, and the gut function.
Experimental data demonstrated that the modulation of the mucosal function and enteric microflora by Lactobacillus plantarum reduces septic morbidity and mortality in animals. The administration of a mix of probiotics has been shown to be more effective than antibiotics to cure pouchitis in humans.
Since patients undergoing colorectal operations have a high risk to develop infections due to the intraoperative contamination with enteral content and the occurence of bacterial translocation, changing the intestinal microflora, by giving lactobacilli may result in important advantages to reduce the risk of intraoperative complications and post operative sepsis.
OBJECTIVES OF THE STUDY
To evaluate if preoperative administration of mucosa reconditioning by probiotic may result in adherence to the colonic mucosa and change of the gut microflora, and may modulate the immune and inflammatory responses and gut function.
EXPERIMENTAL DESIGN AND METHODS
Overall Design and Control Methods Prospective, randomized, double-blind study design.
Centers Departement of Surgery, San Raffaele University, Milan, Italy Departement of Surgery, San Gerardo Hospital, University of Milano-Bicocca, Italy
Number of Subjects/assignment to Formula Groups In these departements about 50 patients are operated for colorectal disease yearly with laparoscopic approach. All these patients are potential candidates to partecipate in the study. It is expected that at least 80% of the patients will agree with partecipation, while during the course of the study about 25% of the partecipants are expected to withdraw. During the intake procedure the inclusion and exclusion criteria are checked. Eligible patients are informed about the objectives, the background and the design of the study. When the patient has given his or her consent to partecipate in the study, the preoperative status is assessed. The patients are then included in the study population and randomly assigned to one of the treatments. During surgery the intraoperative exclusion criteria are checked and non eligible patients excluded from further study. Each group consist of 15 patients in order to assure that at the end of the study 10 patients per group will have completed the study.
Groups:
A: high dose of probiotics (active) compared with B: low dose of probiotics (control) and C: vehicle (placebo)
Dosing Regimen ??
Dosing Scheme:
Preoperative day 5 through 1. Postoperative day 3 through 8. The three preparation will be give 3 times per day (6 hours interval).
Duration of the study 6 months
SCHEDULE OF ASSESSMENTS
Day -6 -1 0 1 2 3 4 5 6 7 8
S
I I I I I MB MB MB MB MB GF GF GF GF GF GF GF GF GF GF
S = select and inform patients I = immunological- inflammatory data MB = microbiological data GF= gastrointestinal function, fecal pH.
Immunological- inflammatory data:
DHR, lymphocyte subset (CD3, CD4, CD8, NK), IgA serum levels, CRP, IL-6, lactate.
Number and subset of intestinal lymphocytes. In vitro response of lymphocytes and macropahges to mitogens and LPS.
Microbiological data:
Quantitative and qualitative culture of stool and colonic mucosa (aerobic and anaerobic total count, aerobic gram negative and positive count)
- During surgery two mucosal samples will be collected for microscopic (adherence test) and microbiological evaluation of the presence of probiotic on the mucosa. Moreover, lymph nodes of the mesentery will harvested for microbiological analysis to assess translocation.
Intraoperative parameters:
Duration of surgery, blood loss, transfusion (amount and type), abdominal contamination.
Gastrointestinal function:
Clinical observation related to gastrointestinal symptoms and defecation pattern
Concomitant Medication and Treatments All patients will receive an antibiotic prophylaxis with cefotetan 2gr 30 minutes before surgery (single shot) and bowel preparation with iso osmotic solution and enema the day before surgery.
STUDY PARAMETERS
Efficacy
Primary Efficacy Parameters
- morphological and microbiological evaluation of the colonic microflora
- gastrointestinal function
Secondary Efficacy Parameters
- immune and inflammatory response
- bacterial translocation
Adverse event
All adverse events encountered during the study will be reported on the Case Report Form. An adverse event is any adverse change from baseline, including intercurrent illness, wich occurs during the course of the study after treatment has started, whether considered related to treatment or not.
Blinding and Randomization
The three study formulae are blinded towards each other. Both researches and patients will be blinded.
Randomization of patients into three groups is performed with the computer randomization program "Random". In this way patient numbers are assigned at random to the group "active formula", "placebo fromula" or "control formula.
Within the three groups randomization is done in blocks of 10 patientnumbers. Per study group three letters are used which are assigned at random to the patientnumbers.
The randomization list may be broken by them in case of an adverse event.
Formulation and Packaging
The formulation of the trial formulae will be in sachet
Dispensing
The investigator is responsible for storage of the study formulae during the time of the study. The sachets must be stored refrigerated until the time of handout. During the actual time that the patient takes the study formula no refrigeration of sachets is required. The investigator is responsible for the hand out of the study formulae in the order of the patientnumber.
A dispensary record of the study formula issued and of any material returned will be kept.
Preparation, Administration and Dosage of test formulae
Route
Before and after the operation the supplement is consumed orally.
Administration protocol For 5 preoperative days in addition of a free choice of hospital food, and after surgery from day 3 to 8.
Assessment of Compliance
The investigator will take high care that patients comply with the conditions set for the study, in order to prevent unnecessary withdrawal because of non compliance.
WITHDRAWAL OF SUBJECTS FROM STUDY
Subjects have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw subjects from the study in the event of intercurrent illness, adverse events, treatment failure after a prescribed procedure, protocols violation, cure, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawal can render the study uninterpretable: therefore, unnecessary, withdrawal of subjects should be avoided. Should subjects decide to withdraw, all efforts will be made to complete and report the observation as thoroughly as possible. A complete final evaluation at the time of the patient's withdrawal should be made with an explanation of why the subjects was withdrawn from the study.
If the reason for removal of a patient from the study is an adverse event or an abnormal laboratory test results, the principal specific event or test will also be recorded on the Case Report Form. In the event of an emergency when the patient's condition requires knowledge of the test treatment, the label may be opened to determine the nature of the test formula dispensed. ANY BROKEN CODE WILL BE CLEARLY JUSTIFIED AND EXPLAINED BY A COMMENT ON THE CASE REPORT FORM, along with the data on which the code was broken.
REPLACEMENT POLICY
Patients withdraw from the study will be replaced if necessary.
CRITERIA FOR EXCLUSION OF SUBJECTS' DATA FROM ANALYSES OF STUDY PARAMETERS
- Intra operative exclusion
- Extensive evidence of non compliance.
Hypothesis Testing
H0: Probiotic bacteria do not affect the microbiology of the gut mucosa and stools gastrointestinal function, immunological or inflammatory parameters compared with control or placebo.
H1: Probiotic bacteria significantly diminishes the number of adhrent and stool pathogens improves gastrointestinal function and/or immunological parameters and/or inflammatory parameters compared with control or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high dose | Experimental | Procedure: Probiotics (La1, BB536)high dose of probiotics (109 cfu) |
| low dose | Experimental | Biological: probiotics (La1, BB536)low dose of probiotics (107 cfu) |
| probiotics | Placebo comparator | Biological: placeboMaltodoxtrin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females between 18 and 80 years of age
- Documented cancer disease of the colorectum as diagnos pre-operatively by positive histology.
- Documented bowel disease (IBD, diverticular disease etc) as diagnosed by barium X-Ray or endoscopy.
- Elective colorectal surgery
- Surgical hospital length of stay anticipated to be at least 8 days
Key exclusion criteria (23 listed)
- Perioperative unresectable tumours
- Perioperative neoplastic ascitis
- Emergency colorectal surgery
- Clinically relevant pulmonary or cardiovascular failure
- Liver failure (known cirrhosis or total bilirubin >3 mg/dl)
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 |
|---|---|---|
| Probiotics (La1, BB536) | Procedure or surgery | high dose |
| probiotics (La1, BB536) | Biological | low dose |
| placeboMaltodoxtrin | Biological | probiotics |
Primary outcome
Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function
1 secondary outcome
Secondary Efficacy Parameters: immune and inflammatory response, bacterial translocation
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 10 Jul 2009.
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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 2 study testing Probiotics (La1, BB536) in people with Colorectal Cancer, run by University of Milano Bicocca at 1 site in Italy.
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 11 inclusion and 23 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 10 Jul 2009. 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 Italy. 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 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?
Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function. 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 10 Jul 2009.