Cystic FibrosisNCT01201434
Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis
A study testing Bio-25 probiotic in people with Cystic Fibrosis, run by Sheba Medical Center.
Trial summary
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Bio-25 probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2013
- 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 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- cystic fibrosis mild to moderate
- at least 3 pulmonary exacerbations requiring antibiotics per year
- Pseudomonas aeruginosa in the sputum
- able to produce sputum
Who cannot join
- severe pulmonary disease
- less than 3 pulmonary exacerbations per year
- unable to produce sputum
About this study
Official title: The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.
Read the detailed description
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients. The study will be a cross-over study of probiotic and placebo arms.
- Conditions
- Cystic Fibrosis
- Being tested
- Bio-25 probiotic
- Keywords
- cystic fibrosis, probiotics, pulmonary, infections
- Medical subject headings
- Cystic Fibrosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-25 probioticDietary supplement
Also called Bio-25 by Supherb
2 tablets per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Probiotics, Treatment, Food Additive | Experimental | Not described Receives: Dietary Supplement: Bio-25 probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of probiotics on the rate of pulmonary infections compared to placebo
The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.
Measured: October 2012
Secondary outcomes (3)
The effect of probiotics on sputum bacteria compared to placebo
Measured: October 2012
The effect of probiotics on sputum inflammatory markers
Measured: October 2012
The effect of probiotics on gastrointestinal inflammation
Measured: October 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Severe allergic reaction in one patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Batia Weiss, Sheba Medical Center
- Investigators
- Batia Weiss, MD, Principal investigator, Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical CenterOri Efrati, MD, Principal investigator, Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201434
- Sponsor's protocol ID
- SHEBA-10-7702-BW-CTIL
- Status last verified
- Jul 2014
- First submitted
- 31 Aug 2010
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiss B, Bujanover Y, Yahav Y, Vilozni D, Fireman E, Efrati O. Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol. 2010 Jun;45(6):536-40. doi: 10.1002/ppul.21138.
PubMed 20503277
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01201434
- Acronym / sponsor ID
- SHEBA-10-7702-BW-CTIL
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, probiotics, pulmonary, infections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Severe allergic reaction in one patient
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Sep 2010 (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.
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.
Detailed description
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients. The study will be a cross-over study of probiotic and placebo arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics, Treatment, Food Additive | Experimental | Dietary Supplement: Bio-25 probiotic |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- cystic fibrosis mild to moderate
- at least 3 pulmonary exacerbations requiring antibiotics per year
- Pseudomonas aeruginosa in the sputum
- able to produce sputum
Key exclusion criteria (3 listed)
- severe pulmonary disease
- less than 3 pulmonary exacerbations per year
- unable to produce sputum
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 |
|---|---|---|
| Bio-25 probioticAlso: Bio-25 by Supherb2 tablets per day for 6 months | Dietary supplement | Probiotics, Treatment, Food Additive |
Primary outcome
The effect of probiotics on the rate of pulmonary infections compared to placebo
Time frame: October 2012
The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.
3 secondary outcomes
The effect of probiotics on sputum bacteria compared to placebo
Time frame: October 2012
The effect of probiotics on sputum inflammatory markers
Time frame: October 2012
The effect of probiotics on gastrointestinal inflammation
Time frame: October 2012
Results and safety
The study was stopped early (reason given: Severe allergic reaction in one patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Background: PubMed 20503277Weiss B, Bujanover Y, Yahav Y, Vilozni D, Fireman E, Efrati O. Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol. 2010 Jun;45(6):536-40. doi: 10.1002/ppul.21138.
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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.
Batia Weiss, MD principal investigator
Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center
Ori Efrati, MD principal investigator
Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Bio-25 probiotic in people with Cystic Fibrosis, run by Sheba Medical Center.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Severe allergic reaction in one patient). Results are not available in the source record.
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?
The effect of probiotics on the rate of pulmonary infections compared to placebo (time frame: October 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201434, which also lists 1 linked publication.
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 22 Jul 2014.