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Saliva testing for the diagnosis of reflux disease in infants


- candidate number17718
- NTR NumberNTR4578
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mei-2014
- Secondary IDsPEP2014 intern onderzoeksnummer
- Public TitleSaliva testing for the diagnosis of reflux disease in infants
- Scientific TitleSalivary pepsin as a diagnostic test in infant gastro-oesophageal reflux disease (GERD)
- ACRONYM
- hypothesisSalivary pepsin tests can play a role in the diagnostic process of infant GERD:
- by excluding GERD; and/or
- by establishing GERD in an early stage of the disease and/or establish the need for further invasive testing
- Healt Condition(s) or Problem(s) studiedGastroesophageal reflux Disease (GERD), Children, Infants
- Inclusion criteria1. Healthy controls
- Informed consent signed by caregiver(s)
- At least 34wks gestational age (GA)
- At most 24 months post natal age (PNA)
- Attending a regular health care check up at Childs health clinic or a physician for an unrelated problem
- Negative score in I-GERQ-R questionnaire


2. Symptomatic infants
- Informed consent signed by caregiver(s)
- At leaast 34wks GA
- At most 18 months post natal age (PNA)
- Attending a regular health care check up at Childs health clinic or a physician for GER related symptoms
- Positive score on I-GERQ-R questionnaire
- Exclusion criteria- Known structural GI abnormalities
- Previous gastro-intestinal (GI) surgery
- Neurological syndromes and development disorders
- Any condition that would make it unsafe for the subject to participate determined by the treating physician.
- Use of anti GER medications (prokinetics, erytromycin, PPI, H2RA, antacida) in the last 5 days before inclusion.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-mei-2014
- planned closingdate31-dec-2016
- Target number of participants300
- Interventions2 weeks of 1 daily 1 mg/kg omeprazol therapy in symptomatic children not responding to 2 weeks of conservative treatment.
- Primary outcome1. Healthy controls:
- Salivary pepsin A concentrations at day 1

2. Symptomatic infants:
- Baseline salivary pepsin A concentrations compared to healthy controls
- Correlation of baseline salivary pepsin A concentrations with clinical outcome during standardized treatment.
- Secondary outcome1. Healthy controls:
Day to day variability between samples taken at day 1 and day 2.

2. Symptomatic infants:
- Correlation of baseline salivary pepsin and pH-MII parameters after two weeks of unsuccessful (no complete response) conservative treatment
- Correlation of salivary pepsin and pH-MII parameters after two weeks of unsuccesful (no complete response) conservative treatment
- Correlation of salivary pepsin and I-GERQ-R scores at different time points.
- Timepoints1.Healthy controls:
- IGERQ-R questionnaire at baseline. Score < 16 to qualify as a healthy control.
- Saliva samples will be collected one hour after a feed on two consecutive days using a blunt sterile plastic single use transfer pipette. Samples will be stored in refrigerator and analyzed for pepin <7 days of collection with an pepsin A specific enzymatic assay.

Symptomatic infants:
- IGERQ-R questionnaire at baseline: Score >15 to qualify as a symptomatic infant. Furthermore I-GERQ-R at day 0, day 14 and day 44. At these timepoints response is defined as follows:
* No response: I-GERQ-R above symptomatic score (>15 points) and no significant improvement (improvement in score <5 points) compared to baseline.
* Partial response: I-GERQ-R above symptomatic score (>15 points) but with significant improvement (improvement in score >4 points) in symptom score compared to baseline OR I-GERQ-R below symptomatic score (<16 points) but no significant improvement (improvement in score >4 points) in symptom score compared to baseline.
* complete response: I-GERQ-R drops below symptomatic score (<16) AND a significant improvement of score (improvement in score >4 points)

- Saliva samples will be collected one hour after a feed at presentation and after two weeks of standard conservative treatment. If the infants have no response or a partial response to this conservative therapy, saliva samples will again be collected at the end of an additional 4 weeks trial of proton pump inhibitor (PPI) treatment. Salivary pepsin will be determined using the method described above.
- 24 hour pH-multichannel intraluminal impedance (pH-MII) will be performed when infants have no response or a partial response to 2 weeks of standard conservative treatment. Reflux index(RI), symptom index (SI), symptom sensitivity index (SSI) and symptom association probability score (SAP) will be used to determine a positive or negative result.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc A. Benninga
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc A. Benninga
- Sponsor/Initiator Academic Medical Center (AMC), Emma Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Emma Children's Hospital
- Publications
- Brief summaryRationale: GERD is common in infants with a prevalence of >12% in the western population. To prevent over- as well as under diagnosis and treatment of infant GERD, there is a clear need to distinguish mild GER related symptoms from pathological GERD in this large group of patients. Currently, the international guidelines propose combined pH and multichannel intraluminal impedance (pH-MII) as a diagnostic tool to assess GERD. However, normal values are lacking and it is unclear how the results of this test relate to treatment outcome. Salivary pepsin measurement has been shown a specific marker for GERD in adults and is a simple, non invasive test. The additional diagnostic and predictive value of pepsin measurement in saliva of symptomatic infants is unknown.
Objective: To test the hypothesis that salivary pepsin tests can play a role in the diagnostic process of infant GERD:
- by excluding GERD; and/or
- by establishing GERD in an early stage of the disease and/or establish the need for further invasive testing
Study design:
1. Cross sectional study in healthy control infants
2. Prospective outcome study in infants with GERD
Study population:
Healthy infants and infatns with GERD from the United Kingdom and The Netherlands
Study protocol: Saliva samples from healthy controls once. Saliva samples from symptomatic infants will be collected at standardized timepoints during a standardized diagnostic and treatment protocol.
Main study parameters/endpoints:
In healthy controls, salivary pepsin A concentrations will be determined to create a reference range In symptomatic infants, baseline salivary pepsin A concentrations will be compared to healthy controls and correlated with clinical outcome during standardized treatment.
- Main changes (audit trail)
- RECORD12-mei-2014 - 3-jun-2014


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