Antibiotic-Associated DiarrheaPhase 4NCT00700557
Probiotics at the Treatment of Antibiotic Associated Diarrhea
A Phase 4 study testing Probiotics - Lactobacillus casei and Bifidobacterium breve and Maize starch in people with Antibiotic-Associated Diarrhea, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study is to know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic-Associated Diarrhea
- What is being tested?
- Probiotics - Lactobacillus casei and Bifidobacterium breve and Maize starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 4
- 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
- Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.
Who cannot join
- Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,
- HIV infections,
- Ulcerative colitis,
- Crohn´s disease,
- Hydroelectrolytic disturbance,
- Small intestine syndrome,
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- Colostomized, jejunostomized
- Lactose intolerance,
- Rapid enteral diet infusion (>120mh/h),
- Hyperosmolar enteral diet.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlândia
Uberlândia, Minas Gerais, 38400-902
About this study
Official title: Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
The purpose of this study is to know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.
Read the detailed description
The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.
- Conditions
- Antibiotic-Associated Diarrhea
- Being tested
- Probiotics - Lactobacillus casei and Bifidobacterium breve, Maize starch
- Keywords
- Antibiotic Associated Diarrhea, probiotics, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics - Lactobacillus casei and Bifidobacterium breveDietary supplement
Experimental group:This group received enteral tube feeding or oral diet plus a juice containing 1 sachet (1g) of probiotics (Lactobacillus casei and Bifidobacterium breve - 6x 108 UFC/g) three times a day.
Maize starchDietary supplement
Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics - Lactobacillus casei and Bifidobacterium breve | Active comparator | Yakult LB®
1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day Receives: Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve |
| maize starch | Placebo comparator | 725mg on juice three times a day Receives: Dietary Supplement: Maize starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Measured: After 24 hours of the intervention started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-Associated DiarrheaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Investigators
- Miguel T Jorge, Medicine, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700557
- Sponsor's protocol ID
- changeme-12332111
- Status last verified
- Aug 2009
- First submitted
- 15 May 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT00700557
- Acronym / sponsor ID
- changeme-12332111
- Conditions
- Antibiotic-Associated Diarrhea
- Keywords
- Antibiotic Associated Diarrhea, probiotics, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Jun 2008 (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 know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.
Detailed description
The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics - Lactobacillus casei and Bifidobacterium breve | Active comparator | Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breveYakult LB® 1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day |
| maize starch | Placebo comparator | Dietary Supplement: Maize starch725mg on juice three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.
Key exclusion criteria (10 listed)
- Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,
- HIV infections,
- Ulcerative colitis,
- Crohn´s disease,
- Hydroelectrolytic disturbance,
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 - Lactobacillus casei and Bifidobacterium breveExperimental group:This group received enteral tube feeding or oral diet plus a juice containing 1 sachet (1g) of probiotics (Lactobacillus casei and Bifidobacterium breve - 6x 108 UFC/g) three times a day. | Dietary supplement | Probiotics - Lactobacillus casei and Bifidobacterium breve |
| Maize starchPlacebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day. | Dietary supplement | maize starch |
Primary outcome
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Time frame: After 24 hours of the intervention started
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 25 Aug 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.
Miguel T Jorge, Medicine principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotics - Lactobacillus casei and Bifidobacterium breve and Maize starch in people with Antibiotic-Associated Diarrhea, run by Federal University of Uberlandia 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 10 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 25 Aug 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses. (time frame: After 24 hours of the intervention started). 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 25 Aug 2009.