Clostridium Difficile InfectionNCT02016820
Effect of Acid Suppression Medication on Pediatric Microbiome
A study testing Omeprazole (suspension) and Lifestyle Modification in people with Clostridium Difficile Infection, run by Columbia University at 1 site in United States.
Trial summary
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. Read more about this study
- Who is it for?
- Ages 0 to 4 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Omeprazole (suspension) and Lifestyle Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Zero to 4 years old
- Being considered for PPI or H2RA treatment for refractory GERD
- Parent is able to give informed consent
Who cannot join
- Prevalent C. difficile infection (excluded via stool PCR at week 0)
- Use of systemic antibiotics within the past 90 days
- Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
- Increased risk for fracture due to vitamin D deficiency or other causes
- Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
- Congenital deficiency in immunity (e.g., such as IgA deficiency)
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- Cystic fibrosis
- Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
- Use of medications with potential interaction with PPIs
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Official title: Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.
Read the detailed description
Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Omeprazole (suspension), Lifestyle Modification
- Keywords
- Clostridium Difficile Infection, Proton Pump Inhibitors, Histamine-2 Receptor Antagonists, Gastroesophageal Reflux Disease
- Medical subject headings
- Clostridium Infections, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole (suspension)Drug
Also called As above
1 mg/kg/day
Lifestyle ModificationOther
Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole (suspension) | Experimental | Open-label, with all subjects receiving omeprazole Receives: Drug: Omeprazole (suspension) |
| Lifestyle Modification | Other | Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Receives: Other: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications
Measured: From week 12 to week 4
Secondary outcomes (1)
Percent Subjects Eating High Fiber Diet
At each study visit, we will assess the effects of longterm diet on the microbiome by using the Harvard-Willett Food Frequency Questionnaire. Using this data, we will classify each subject as low vs high fiber.
Measured: Up to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian A Abrams, MD, Columbia University
- Investigators
- Julian S Abrams, MD, MS, Principal investigator, Columbia UniversityDaniel E Freedberg, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016820
- Sponsor's protocol ID
- AAAM9955
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2013
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children
- ClinicalTrials.gov ID
- NCT02016820
- Acronym / sponsor ID
- AAAM9955
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium Difficile Infection, Proton Pump Inhibitors, Histamine-2 Receptor Antagonists, Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.
Detailed description
Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole (suspension) | Experimental | Drug: Omeprazole (suspension)Open-label, with all subjects receiving omeprazole |
| Lifestyle Modification | Other | Other: Lifestyle ModificationTreated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) |
Who may qualify
- Ages
- 0 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Zero to 4 years old
- Being considered for PPI or H2RA treatment for refractory GERD
- Parent is able to give informed consent
Key exclusion criteria (9 listed)
- Prevalent C. difficile infection (excluded via stool PCR at week 0)
- Use of systemic antibiotics within the past 90 days
- Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
- Increased risk for fracture due to vitamin D deficiency or other causes
- Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
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 |
|---|---|---|
| Omeprazole (suspension)Also: As above1 mg/kg/day | Drug | Omeprazole (suspension) |
| Lifestyle ModificationStandard lifestyle modification: small meals, upright feeding, elevation of the head of the bed | Other | Lifestyle Modification |
Primary outcome
Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications
Time frame: From week 12 to week 4
1 secondary outcome
Percent Subjects Eating High Fiber Diet
Time frame: Up to Week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julian S Abrams, MD, MS principal investigator
Columbia University
Daniel E Freedberg, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeprazole (suspension) and Lifestyle Modification in people with Clostridium Difficile Infection, run by Columbia University at 1 site in United States.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 26 Dec 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications (time frame: From week 12 to week 4). 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 26 Dec 2023.