Carob bean gum and reflux in infants
Recruiting
- Conditions
- ncomplicated oesophageal reflux, infants 2-6 months, oesophageal pH monitoring
- Registration Number
- NL-OMON20846
- Lead Sponsor
- Saint Marina Hospital, Varna, Bulgaria
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1) 2-6 months of age with a score of I-GERQ more than 7, as defined by Orenstein.
2) Proven acid or non-acid reflux with pH-Z ambulatory 24-hour pH and impedance recorder
Exclusion Criteria
1) Preferred no breastfeeding at time of inclusion. When the inclusion of participants in not possible because of this criteria, 25% breast milk of total daily milk intake is allowed.
2) Cow’s milk protein allergy diagnosed as positive IgE and/or positive prick reactions to cow’s milk and/or eosinophilia in differential blood count,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Components of 24-h Oesophageal pH Monitoring using a Digitrapper pH-Z ambulatory 24-hour pH and impedance recorder:<br /><br>• Percent total time pH < 4<br /><br>• Percent Upright time pH < 4<br /><br>• Percent Supine time pH < 4<br /><br>• Number of reflux episodes<br /><br>• Number of reflux episodes ≥ 5 min<br /><br>• Longest reflux episode (minutes)<br /><br>• SI (symptom index for reflux)<br /><br>• SSI (symptom sensitivity index)<br /><br>• SAP (symptom associated probability)<br>
- Secondary Outcome Measures
Name Time Method The nuimber of visible refluxes and stool consistency as monitored by the parent using a 3-days diary.