Gastroesophageal Reflux DiseasePhase 4NCT01782118
LGG for Prevention of Infectious Complications During PPI Treatment in Children
A Phase 4 study testing Lactobacillus GG in people with Gastroesophageal Reflux Disease and Gastrointestinal Infections, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections
- What is being tested?
- Lactobacillus GG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2013to Jul 2014
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age <5,
- clinical symptoms of GERD
- treatment with proton pump inhibitors
- signed informed consent
Who cannot join
- treatment with PPI within the last 4 weeks for at least 2 weeks
- administration of probiotics within 7 days prior to the study
- acute or chronic respiratory tract infections
- acute or chronic gastrointestinal tract infections
- neurological disorders
- immunodeficiency
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, 02-091
Katarzyna Krenlke, MD, +48224523204, katarzynakrenke@gmail.com
Piotr Dziechciarz, MD, +48224523292
About this study
Official title: Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.
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.
Read the detailed description
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.
- Conditions
- Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections
- Being tested
- Lactobacillus GG
- Medical subject headings
- Gastroesophageal Reflux, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GGDietary supplement
Also called Dicoflor
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus GG | Experimental | Lactobacillus GG given for six weeks two times per day. Receives: Dietary Supplement: Lactobacillus GG |
| Placebo | Placebo comparator | Placebo two times per day for six weeks Receives: Dietary Supplement: Lactobacillus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory tract infections
Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention
Measured: 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
Measured: up to 3 months after termination of intervention
Secondary outcomes (2)
Number of pneumonias
during intervention plus 3 months after termination of the intervention
Measured: 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.
Measured: up to 3 months after termination of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Szajewska, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782118
- Sponsor's protocol ID
- 1/2013
- Status last verified
- Oct 2013
- First submitted
- 21 Jan 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01782118
- Acronym / sponsor ID
- 1/2013
- Conditions
- Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 1 Feb 2013 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus GG | Experimental | Dietary Supplement: Lactobacillus GGLactobacillus GG given for six weeks two times per day. |
| Placebo | Placebo comparator | Dietary Supplement: Lactobacillus GGPlacebo two times per day for six weeks |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age <5,
- clinical symptoms of GERD
- treatment with proton pump inhibitors
- signed informed consent
Key exclusion criteria (6 listed)
- treatment with PPI within the last 4 weeks for at least 2 weeks
- administration of probiotics within 7 days prior to the study
- acute or chronic respiratory tract infections
- acute or chronic gastrointestinal tract infections
- neurological disorders
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 GGAlso: Dicoflor | Dietary supplement | Lactobacillus GG, Placebo |
Primary outcome
Respiratory tract infections
Time frame: up to 3 months after termination of intervention
Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention
Gastrointestinal tract infections
Time frame: up to 3 months after termination of intervention
Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention
2 secondary outcomes
Number of pneumonias
Time frame: up to 3 months after termination of intervention
Adverse events
Time frame: up to 3 months after termination of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
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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.
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 GG in people with Gastroesophageal Reflux Disease and Gastrointestinal Infections, run by Medical University of Warsaw at 1 site in Poland.
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 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2013. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Krenke, MD (+48224523204, katarzynakrenke@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory tract infections (time frame: up to 3 months after termination of intervention). The study lists 2 primary outcomes in all. 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 31 Oct 2013.