GERDNCT03747991
How Reflux Medications Affect the Microbiome of Infants
An observational study of GERD and Dysbiosis, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. Read more about this study
- Who is it for?
- Ages 2 to 12 monthsHealthy volunteers can take part
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 31 Jul 2019
- Phase
- Observational
- 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 2 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants must be healthy, male or female term infants (gestational age ≥37 weeks) who are at least 2 months old, on or off H2RA medication, who meet inclusion/exclusion criteria. Infants will be recruited from Nemours Children's Clinic and through local advertisements in the greater Wilmington / Northern Delaware area.
Who may be able to join
- Full term, at least 2 months of age
- No exposure OR at least 14 days of exposure to H2-receptor antagonist medication
- No exposure to probiotics or antibiotics
Who cannot join
- Current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal)
- Gastrointestinal mucosal disease, or have clinically significant constipation
- Any history of exposure to proton pump inhibitors
- Unvaccinated infants
- Infants with weight-for-length either below the 3rd percentile for age or above the 97th percentile for age
- Infants with rapid weight gain, defined as change in weight-for-length z-score exceeding +0.67 from birth to 4 months of age or birth to 6 months of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Effect of Histamine-2 Receptor Antagonists on the Microbiome of Full Term Infants
The changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. Whether these medications change the gut microbiota and microbiome, and what that change may imply for children on these medications, is the focus of this study.
Read the detailed description
Gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. The microbial colonization of the infant gut is known to play a key role in immunologic and metabolic pathways impacting on human health. Disruptions during the complex process of microbial colonization have been shown to increase disease susceptibility during life. A variety of factors are known to influence the gut microbiota, including mode of delivery of neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs, infections, and environmental microbial exposures.
The diagnosis of gastroesophageal reflux disease in the infant population has increased during the past two decades. Acid suppression medications are used commonly in infants for gastroesophageal reflux disease and other acid-related conditions despite little evidence of their efficacy. Multiple studies have shown adverse effects in pediatric patients using either proton pump inhibitors or H2 receptor antagonists, the two classes of acid suppression medications that are most frequently used in children. Some of these adverse effects may result from alterations in the microbiome caused by these medications. Prior studies have demonstrated significant changes in microbial composition of both gastric and intestinal microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior studies have looked at the effect of H2 receptor antagonists on the microbiome in healthy, full term infants.
- Keywords
- Infant GERD, H2RA medication
- Medical subject headings
- Gastroesophageal Reflux, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Infants | Infants ages 2 months to 12 months who are not on H2RA medication. | |
| Treated Infants | Infants ages 2 months to 12 months who are taking H2RA medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome taxa
16S Metagenomic taxonomy of gut microbiome
Measured: At time of sampling - once at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start13 Aug 2018
- Primary completion30 Apr 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Di Guglielmo, Nemours Children's Clinic
- Investigators
- Matthew Di Guglielmo, MD PhD, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747991
- Sponsor's protocol ID
- 1231469
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2018
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 16S metagenomic sequence data, deidentified, will be made available through either the database of Genotypes and Phenotypes (dbGap) or Sequence Read Archive (SRA).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Histamine-2 Receptor Antagonists on the Microbiome of Full Term Infants
- ClinicalTrials.gov ID
- NCT03747991
- Acronym / sponsor ID
- 1231469
- Keywords
- Infant GERD, H2RA medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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.
The changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. Whether these medications change the gut microbiota and microbiome, and what that change may imply for children on these medications, is the focus of this study.
Detailed description
Gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. The microbial colonization of the infant gut is known to play a key role in immunologic and metabolic pathways impacting on human health. Disruptions during the complex process of microbial colonization have been shown to increase disease susceptibility during life. A variety of factors are known to influence the gut microbiota, including mode of delivery of neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs, infections, and environmental microbial exposures.
The diagnosis of gastroesophageal reflux disease in the infant population has increased during the past two decades. Acid suppression medications are used commonly in infants for gastroesophageal reflux disease and other acid-related conditions despite little evidence of their efficacy. Multiple studies have shown adverse effects in pediatric patients using either proton pump inhibitors or H2 receptor antagonists, the two classes of acid suppression medications that are most frequently used in children. Some of these adverse effects may result from alterations in the microbiome caused by these medications. Prior studies have demonstrated significant changes in microbial composition of both gastric and intestinal microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior studies have looked at the effect of H2 receptor antagonists on the microbiome in healthy, full term infants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Infants | – | –Infants ages 2 months to 12 months who are not on H2RA medication. |
| Treated Infants | – | –Infants ages 2 months to 12 months who are taking H2RA medication. |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants must be healthy, male or female term infants (gestational age ≥37 weeks) who are at least 2 months old, on or off H2RA medication, who meet inclusion/exclusion criteria. Infants will be recruited from Nemours Children's Clinic and through local advertisements in the greater Wilmington / Northern Delaware area.
Key inclusion criteria (3 listed)
- Full term, at least 2 months of age
- No exposure OR at least 14 days of exposure to H2-receptor antagonist medication
- No exposure to probiotics or antibiotics
Key exclusion criteria (6 listed)
- Current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal)
- Gastrointestinal mucosal disease, or have clinically significant constipation
- Any history of exposure to proton pump inhibitors
- Unvaccinated infants
- Infants with weight-for-length either below the 3rd percentile for age or above the 97th percentile for age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome taxa
Time frame: At time of sampling - once at enrollment
16S Metagenomic taxonomy of gut microbiome
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 12 Jun 2024.
- Individual participant dataSharing planned: Yes. 16S metagenomic sequence data, deidentified, will be made available through either the database of Genotypes and Phenotypes (dbGap) or Sequence Read Archive (SRA).
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Matthew Di Guglielmo, MD PhD principal investigator
Nemours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD and Dysbiosis, run by Nemours Children's Clinic 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 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: finished, as of the sponsor's last update on 12 Jun 2024. 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?
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?
Microbiome taxa (time frame: At time of sampling - once at enrollment). 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 12 Jun 2024.