CYSTIC FIBROSISPhase 4NCT01737983
Effect of Lactobacillus Reuteri in Cystic Fibrosis
A Phase 4 study testing Lactobacillus reuteri in people with CYSTIC FIBROSIS, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts. Read more about this study
- Who is it for?
- Ages 6 to 42 years
- Conditions the study is for
- CYSTIC FIBROSIS
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Jul 2011
- 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 6 to 42 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Forced expiratory volume in the 1st second (FEV1) > 70%.
- No inhaled or systemic steroids.
- No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.
- No serious organ involvement.
Who cannot join
- History of pulmonary exacerbation or upper respiratory infection in the previous two months.
- Changes in medications in the past two months.
- History of hemoptysis in the past two months.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"
Roma, 00161
About this study
Official title: Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.
The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.
Read the detailed description
The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. During the disease, most children become colonized with Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function. Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the rate and severity of pulmonary exacerbations, children with CF are put on heavy load of antibiotics.
Intestinal inflammation is another typical finding in CF patients and gut bacterial overgrowth may be present.
Probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. In addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. The effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. The latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.
- Conditions
- CYSTIC FIBROSIS
- Being tested
- Lactobacillus reuteri, placebo
- Keywords
- cystic fibrosis, probiotics, Lactobacillus reuteri
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
Also called (LR) ATCC55730
Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months.
placeboDietary supplement
The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri (LR) ATCC55730 | Experimental | The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10^10 colony-forming units) for 6 months Receives: Dietary Supplement: Lactobacillus reuteri |
| placebo | Placebo comparator | The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation for 6 months During the test period, patients were not allowed to consume any other product that contained probiotics or prebiotics Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.
Measured: 6 months of observation
Efficacy
Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
Measured: 6 months of observation
efficacy
Evaluate number of gastrointestinal and upper respiratory tract infections.
Measured: 6 months of observation
efficacy
Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.
Measured: 6 months of observation
Secondary outcomes (5)
efficacy
Evaluate change in qualitative sputum bacteria;
Measured: 6 months of observation
efficacy
Evaluate change in fecal calprotectin concentration.
Measured: 6 months of observation
efficacy
Evaluate interleukin 8 levels in plasma and induced sputum.
Measured: 6 months of observation
efficacy
Evaluate change in quantitative sputum bacteria;
Measured: 6 months of observation
efficacy
Evaluate tumor necrosis factor α levels in plasma and induced sputum.
Measured: 6 months of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
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.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Di Nardo, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737983
- Sponsor's protocol ID
- lactobacillus reuteri in fc
- Status last verified
- Nov 2012
- First submitted
- 12 Jul 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Di Nardo G, Oliva S, Menichella A, Pistelli R, De Biase RV, Patriarchi F, Cucchiara S, Stronati L. Lactobacillus reuteri ATCC55730 in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):81-6. doi: 10.1097/MPG.0000000000000187.
PubMed 24121143
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01737983
- Acronym / sponsor ID
- lactobacillus reuteri in fc
- Conditions
- CYSTIC FIBROSIS
- Keywords
- cystic fibrosis, probiotics, Lactobacillus reuteri
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Nov 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.
The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.
Detailed description
The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. During the disease, most children become colonized with Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function. Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the rate and severity of pulmonary exacerbations, children with CF are put on heavy load of antibiotics.
Intestinal inflammation is another typical finding in CF patients and gut bacterial overgrowth may be present.
Probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. In addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. The effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. The latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri (LR) ATCC55730 | Experimental | Dietary Supplement: Lactobacillus reuteriThe tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10^10 colony-forming units) for 6 months |
| placebo | Placebo comparator | Dietary Supplement: placeboThe placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation for 6 months During the test period, patients were not allowed to consume any other product that contained probiotics or prebiotics |
Who may qualify
- Ages
- 6 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Forced expiratory volume in the 1st second (FEV1) > 70%.
- No inhaled or systemic steroids.
- No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.
- No serious organ involvement.
Key exclusion criteria (3 listed)
- History of pulmonary exacerbation or upper respiratory infection in the previous two months.
- Changes in medications in the past two months.
- History of hemoptysis in the past two months.
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 |
|---|---|---|
| Lactobacillus reuteriAlso: (LR) ATCC55730Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months. | Dietary supplement | Lactobacillus reuteri (LR) ATCC55730 |
| placeboThe placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day | Dietary supplement | placebo |
Primary outcome
Efficacy
Time frame: 6 months of observation
Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.
Efficacy
Time frame: 6 months of observation
Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.
efficacy
Time frame: 6 months of observation
Evaluate number of gastrointestinal and upper respiratory tract infections.
efficacy
Time frame: 6 months of observation
Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.
5 secondary outcomes
efficacy
Time frame: 6 months of observation
efficacy
Time frame: 6 months of observation
efficacy
Time frame: 6 months of observation
efficacy
Time frame: 6 months of observation
efficacy
Time frame: 6 months of observation
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 30 Nov 2012.
- Derived from this study: PubMed 24121143Di Nardo G, Oliva S, Menichella A, Pistelli R, De Biase RV, Patriarchi F, Cucchiara S, Stronati L. Lactobacillus reuteri ATCC55730 in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):81-6. doi: 10.1097/MPG.0000000000000187.
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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 4 study testing Lactobacillus reuteri in people with CYSTIC FIBROSIS, run by Azienda Policlinico Umberto I 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 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: finished, as of the sponsor's last update on 30 Nov 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 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 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?
Efficacy (time frame: 6 months of observation). The study lists 4 primary outcomes in all. 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 NCT01737983, 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 30 Nov 2012.