Trials / Unknown
UnknownNCT02806453
Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- Sponsor
- Policlinico Hospital · Academic / Other
- Sex
- All
- Age
- 3 Months – 1 Year
- Healthy volunteers
- Accepted
Summary
A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week. Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | thickened formula | |
| DIETARY_SUPPLEMENT | Mg alginate | |
| BEHAVIORAL | reassurance with lifestyle changes |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2017-07-01
- Completion
- 2017-12-01
- First posted
- 2016-06-20
- Last updated
- 2016-06-21
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02806453. Inclusion in this directory is not an endorsement.