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Randomised controlled trial of melatonin for paediatric functional abdominal pain disorders
Valeria Dipasquale1, Lisa Palermo1, Andrea Barbalace1
1Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy.
Insights
Melatonin and Lactobacillus Rhamnosus GG significantly improved pediatric functional abdominal pain disorders within 4 weeks. This combination therapy offers a promising treatment option for children experiencing these conditions.
Area of Science:
- Gastroenterology
- Pediatric Medicine
- Neurogastroenterology
Background:
- The brain-gut axis plays a crucial role in gastrointestinal function.
- Melatonin influences the gut microbiome and gastrointestinal motility.
- Functional abdominal pain disorders (FAPDs) are common in children.
Purpose of the Study:
- To evaluate the efficacy of melatonin combined with Lactobacillus Rhamnosus GG in treating pediatric FAPDs.
- To assess the impact of this combination on abdominal pain index (API) scores.
Main Methods:
- A randomized controlled trial involving 42 children (4-18 years) diagnosed with FAPDs.
- Participants received either melatonin with Lactobacillus Rhamnosus GG or placebo with Lactobacillus Rhamnosus GG for 4 weeks.
- The primary endpoint was a 50% reduction in mean API from baseline to week 12.
Main Results:
- The melatonin group showed a significant reduction in API scores between weeks 0 and 4 (T0 and T1).
- While the mean API was reduced by over 50% in the melatonin group by week 12 (T2), the difference between groups was not statistically significant at this time point.
- Individual pain frequency and intensity scores also showed significant improvements early in the treatment.
Conclusions:
- This is the first study to explore the combined use of melatonin and Lactobacillus Rhamnosus GG for pediatric FAPDs.
- The combination of melatonin and Lactobacillus Rhamnosus GG presents a potential therapeutic strategy for managing FAPDs in children.
Aim:
Melatonin seems to have a positive impact on the brain-gut axis and many direct and indirect effects on the gastrointestinal tract. This trial aimed at assessing the efficacy of melatonin combined with Lactobacillus Rhamnosus GG given in the treatment of paediatric patients with functional abdominal pain disorders.
Methods:
Forty-two patients aged 4-18 years old who fulfilled the Rome IV Diagnostic Criteria for functional abdominal pain disorders were enrolled. Melatonin 3 or 5 mg in combination with Lactobacillus Rhamnosus GG (group 1, n = 22) or a placebo in combination with Lactobacillus Rhamnosus GG (control group, n = 20) were taken in the evening for a period of 4 weeks. The study duration was 12 weeks. The primary study endpoint was represented by clinical improvement at week 12 - defined as at least a 50% reduction in mean abdominal pain index (API) from baseline to week 12.
Results:
The mean API was reduced by more than 50% between T0 and T2 in the group of children treated with melatonin. However, the difference in the distributions of the variations of the scores between the two groups was not significant between T0 and T2 (P = 0.082), while it was significant between T0 and T1 (P = 0.001). Similar results were obtained by analysing the API variables 'weekly frequency of pain' (item 1) and 'perceived intensity of pain' (item 4) individually.
Conclusions:
This is the first study to investigate the role of the combination of melatonin and Lactobacillus Rhamnosus GG in the treatment of children with functional abdominal pain disorders. Melatonin combined with Lactobacillus Rhamnosus GG can be considered a therapeutic option for these conditions in children.
