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Severe allergic reaction in one patient
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics, Treatment, Food Additive | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-25 probiotic | Dietary Supplement | 2 tablets per day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | October 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of probiotics on sputum bacteria compared to placebo | October 2012 | |
| The effect of probiotics on sputum inflammatory markers | October 2012 | |
| The effect of probiotics on gastrointestinal inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Batia Weiss, MD | Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center | Principal Investigator |
| Ori Efrati, MD | Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20503277 | Background | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| October 2012 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |