Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.
Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.
Study design: Randomized, double-blind, placebo controlled trial.
Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus GG | Experimental | Lactobacillus GG given for six weeks two times per day. |
|
| Placebo | Placebo Comparator | Placebo two times per day for six weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus GG | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory tract infections | Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention | up to 3 months after termination of intervention |
| Gastrointestinal tract infections | Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention | up to 3 months after termination of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pneumonias | during intervention plus 3 months after termination of the intervention | up to 3 months after termination of intervention |
| Adverse events | Number and character of adverse events during intervention plus 3 months after termination of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| serum level of 25OHD | at 6 weeks | |
| serum level of ferritin | at 6 weeks | |
| Total iron binding capacity |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Krenke, MD | Contact | +48224523204 | katarzynakrenke@gmail.com | |
| Piotr Dziechciarz, MD | Contact | +48224523292 | piotrdz@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Recruiting | Warsaw | 02-091 | Poland |
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 3 months after termination of intervention |
| at 6 weeks |
| serum level of ferrum | at 6 weeks |
| fecal calprotectin | at 6 weeks |
| D004066 | Digestive System Diseases |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |