To test the hypothesis that salivary pepsin is able to predict outcome of treatment in GERD suspected infants.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameters:
1. Healthy controls: Salivary pepsin concentrations at day 1 to create
reference values.
2. Symptomatic infants: correlation of baseline pepsin values and clinical
outcome after initial conservative treatment (incl feed thickener) and (if
applicable) PPI treatment.
3. Difference between salivary pepsin concentrations of healthy controls and
symptomatic infants at baseline
Secondary outcome
Healthy controls:
Day to day variability between samples taken at day 1 and day 2.
Symptomatic infants:
1.Salivary pepsin concentrations after conservative treatment and feed
thickeners compared to baseline and compared between responders/non responders
2.For non responders: salivary pepsin concentration after subsequent proton
pump inhibitor treatment compared to baseline and after-conservative treatment
pepsin levels.
3.Correlation between pH-MII parameters (below) and pepsin saliva
concentrations at baseline, after initial standard treatment and after 4 weeks
PPI treatment.
a. Reflux index (% of the time the esophageal pH is < 4)
b. Symptom association probability (SAP): Calculation of the statistical
relationship between symptoms and reflux episodes using Fisher*s exact test
c. Symptom index (SI): the percentage of symptom events that are temporally
related to a reflux event. Defined as: (Number of reflux associated symptoms
/Total number of symptoms) ×100%
d. Symptom sensitivity index (SSI): the percentage of reflux events that are
temporally related to a symptom. Defined as: (Number of symptom associated
reflux episodes/Total number of reflux episodes) ×100%
Background summary
Gastro-esophageal reflux is the involuntary movement of gastric contents into
the esophagus and is referred to as GER disease (GERD) when causing troublesome
symptoms and/or complications. 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.
Study objective
To test the hypothesis that salivary pepsin is able to predict outcome of
treatment in GERD suspected infants.
Study design
1. Cross sectional study in healthy control infants
2. Prospective outcome study in infants with GERD
Protocol:
1.Saliva samples from healthy controls will be collected one hour after a feed
on two consecutive days (day 1 and day 2, min 2 max 5 samples per day).
2.Saliva samples from symptomatic infants will be collected one hour after a
feed (min 2 max 5 samples per day) at presentation and after two weeks of
standard conservative treatment including feed thickeners. If the infants do
not respond to this therapy, a pH-MII is performed followed by a 4 weeks trial
of proton pump inhibitor (PPI) treatment and a saliva samples will be taken a
last time after PPI treatment.
Definitions gastro esophageal reflux disease and response
Asymptomatic: initial score on I-GERQ-R questionnaire <16 points and no
troublesome signs and symptoms of GER as reported by parents or physician
Symptomatic: initial score on I-GERQ-R questionnaire >=16 points and reported
troublesome signs and symptoms of GER as by parents and judged physician
Response:
A. No response: I-GERQ-R above symptomatic score (>=16 points) and no
significant improvement (delta <5) in symptom score compared to baseline.
B. Partial response (partial treatment effect): I-GERQ-R above symptomatic
score (>=16 points) but WITH significant improvement (delta >=5) in symptom score
compared to baseline
OR
I-GERQ-R drops below symptomatic score (<16 points) but WITHOUT significant
improvement (delta >=5) in symptom score compared to baseline .
C. Complete response (cured): I-GERQ-R drops below symptomatic score (<16) AND
a significant improvement of symptom score compared to baseline .
Group A & B will be considered non responders and taken to the next phase of
the study
Study burden and risks
Sampling saliva for pepsin measurement is a non invasive possible new
diagnostic tool for GERD in infants. The saliva is collected via a blunt,
disposable transfer pipet that is placed under the tongue and is completely
harmless to the infant. Therefore, burden and risks associated with
participation are estimated minimal. All diagnostic and treatment approaches in
this study are according to current guidelines for suspected GERD in infants.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Healthy controls
- Informed consent signed by caregiver(s)
- >=34wks gestational age- 24 months postnatal age
- Negative score in I-GERQ-R questionnaire (<16);Symptomatic infants
- Informed consent signed by caregiver(s)
- >=34wks GA - 18 months PNA
- Attending either a general pediatric outpatient clinic or specific pediatric gastroenterology department for gastro esophageal reflux related symptoms
- Positive score on I-GERQ-R questionnaire (>=16 points)
Exclusion criteria
Valid for both healthy subjects and symptomatic infants:
- Known structural gastro-intestinal abnormalities
- Previous gastro-intestinal 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 gastro esophageal reflux medications (prokinetics, erythromycin, proton pump inhibitors, H2 receptor antagonists, antacida) in the last 5 days before inclusion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 4578 |
| CCMO | NL49655.018.14 |