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A clinical trial with an "anti-regurgitation" formula
Y Vandenplas1, S Hachimi-Idrissi, A Casteels
1Academic Children's Hospital, Free University of Brussels, Belgium.
Insights
A new anti-regurgitation formula with bean gum significantly reduced infant regurgitations and improved gastro-oesophageal reflux (GOR) metrics. Conservative treatments like reassurance and postural therapy are also effective for infant regurgitation.
Area of Science:
- Pediatrics
- Gastroenterology
Background:
- Infant regurgitation is a common concern for parents.
- Gastro-oesophageal reflux (GOR) can cause discomfort and complications in infants.
Purpose of the Study:
- To evaluate the efficacy of an anti-regurgitation formula containing bean gum preparation.
- To assess the impact on infant regurgitation frequency and GOR.
Main Methods:
- A double-blind prospective study involving 20 infants (1 week to 4 months old) with regurgitation.
- Comparison between a formula with bean gum (treatment) and a placebo formula.
- 24-hour esophageal pH monitoring before and during treatment.
Main Results:
- Significant decrease in regurgitations in both treatment (P=0.002) and placebo (P=0.032) groups.
- Treatment group showed a significant decrease in esophageal pH < 4.0 percentage.
- Bean gum formula improved clinical remission and normalized some pH parameters.
Conclusions:
- Conservative infant regurgitation treatments (reassurance, postural therapy) are often sufficient for clinical remission.
- Milk thickening products, like bean gum, may enhance clinical remission and improve GOR parameters.
Abstract:
To determine whether a new "anti-regurgitation formula" containing a bean gum preparation decreases the number of regurgitations and gastro-oesophageal reflux (GOR), we studied 20 infants from 1 week to 4 months of age, referred for evaluation of regurgitation, in a double-blind prospective study. The number of regurgitations decreased significantly in both the treatment group (the formula with thickening product, positional treatment, parental reassurance) and the placebo group (the same formula without thickening product, positional treatment, parental reassurance) (P 0.002 and 0.032, respectively). The results of a 24-h oesophageal pH monitoring, performed before and during treatment, showed a significant decrease in the percentage of time oesophageal pH was < 4.0 in the treatment group. It is concluded that conservative treatment of regurgitation in infants, consisting mainly of parental reassurance and postural therapy, is sufficient to obtain clinical remission in most patients. In addition, milk thickening products tend to improve clinical remission and contribute to the normalisation of some pH metric parameters.