Gastroesophageal RefluxNCT02359604
The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
A study testing PPI therapy and Stool sample in people with Gastroesophageal Reflux, run by Medical University of Graz at 1 site in Austria.
Trial summary
Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- PPI therapy and Stool sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2014to 7 Feb 2017
- 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 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy
Who cannot join
- neurological impairments
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pediatric and Adolescent Surgery, Medical University of Graz
Graz, Styria, 8036
About this study
Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce.
This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing.
Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be considered statistically significant.
- Conditions
- Gastroesophageal Reflux
- Being tested
- PPI therapy, Stool sample
- Keywords
- infant, ppi, proton pump inhibitor, microbiome, Microbiota
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI therapyDrug
Also called esomeprazole
PPI therapy (medication has FDA approval) for 8 weeks in children with proven GERD.
The medication used (esomeprazole) in this trial is approved by the FDA
Stool sampleProcedure or surgery
Stool sample will be obtained before initiation of PPI (before PPI therapy)
Stool sampleProcedure or surgery
Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)
Stool sampleProcedure or surgery
Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study -microbiome | Other | This is a single-arm study. The patients will serve as their own controls. The PPI administered for PPI-therapy is already FDA approved. A stool sample will be obtained for intestinal microbiome testing before PPI, under PPI and after PPI therapy. Receives: Drug: PPI therapy; Procedure: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities
The change of intestinal microbiota under PPI therapy will be examined.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2014
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
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 Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Castellani Christoph, MD, Medical University of Graz
- Investigators
- Christoph Castellani, MD, Principal investigator, Dept. of Pediatric and Adolescent Surgery, Medical University Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359604
- Sponsor's protocol ID
- MUG-KCH-1
- Status last verified
- Feb 2017
- First submitted
- 31 Oct 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Castellani C, Singer G, Kashofer K, Huber-Zeyringer A, Flucher C, Kaiser M, Till H. The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study. Front Cell Infect Microbiol. 2017 Oct 11;7:444. doi: 10.3389/fcimb.2017.00444. eCollection 2017.
PubMed 29075620
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
- ClinicalTrials.gov ID
- NCT02359604
- Acronym / sponsor ID
- MUG-KCH-1
- Conditions
- Gastroesophageal Reflux
- Keywords
- infant, ppi, proton pump inhibitor, microbiome, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 10 Feb 2015 (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.
Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce.
This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing.
Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study -microbiome | Other | Drug: PPI therapy, Procedure: Stool sampleThis is a single-arm study. The patients will serve as their own controls. The PPI administered for PPI-therapy is already FDA approved. A stool sample will be obtained for intestinal microbiome testing before PPI, under PPI and after PPI therapy. |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy
Key exclusion criteria (1 listed)
- neurological impairments
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 |
|---|---|---|
| PPI therapyAlso: esomeprazolePPI therapy (medication has FDA approval) for 8 weeks in children with proven GERD. The medication used (esomeprazole) in this trial is approved by the FDA | Drug | Single Arm Study -microbiome |
| Stool sampleStool sample will be obtained before initiation of PPI (before PPI therapy) | Procedure or surgery | Single Arm Study -microbiome |
| Stool sampleStool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy) | Procedure or surgery | Single Arm Study -microbiome |
| Stool sampleStool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy). | Procedure or surgery | Single Arm Study -microbiome |
Primary outcome
microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities
Time frame: 16 weeks
The change of intestinal microbiota under PPI therapy will be examined.
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 8 Feb 2017.
- Derived from this study: PubMed 29075620Castellani C, Singer G, Kashofer K, Huber-Zeyringer A, Flucher C, Kaiser M, Till H. The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study. Front Cell Infect Microbiol. 2017 Oct 11;7:444. doi: 10.3389/fcimb.2017.00444. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
Christoph Castellani, MD principal investigator
Dept. of Pediatric and Adolescent Surgery, Medical University Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI therapy and Stool sample in people with Gastroesophageal Reflux, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 1 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 8 Feb 2017. 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 Austria. 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. 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 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?
microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities (time frame: 16 weeks). 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 NCT02359604, 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 8 Feb 2017.