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Safety and Effectiveness of Prucalopride in Children with Functional Constipation with and without Upper Symptoms
Alejandro Velez1, Ajay Kaul1,2, Khalil I El-Chammas1,2
1Gastroenterology, Hepatology and Nutrition, Pediatric Gastroenterology, Cincinnati Children's Hospital Medical Center, Suite T8.382, 3333 Burnet Ave, Cincinnati, OH, 45229, USA.
Insights
Prucalopride effectively treated functional constipation (FC) and associated upper GI symptoms in children. While generally safe, it may worsen mood in a small subset of patients with pre-existing mood disorders.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
Background:
- Pediatric studies on prucalopride for gastrointestinal (GI) disorders have yielded inconsistent outcomes.
- Functional constipation (FC) in children presents challenges, often co-occurring with upper GI symptoms.
Purpose of the Study:
- To evaluate the safety and efficacy of prucalopride in pediatric patients diagnosed with functional constipation.
- To assess the impact of prucalopride on co-existing upper GI symptoms and dysphagia in this population.
Main Methods:
- A retrospective analysis compared pediatric patients with FC receiving combined prucalopride and conventional therapy against those on conventional therapy alone.
- Patients were matched for age, gender, race, and fecal soiling. Outcomes included FC response, functional upper GI symptom resolution, dysphagia improvement, and adverse events.
Main Results:
- No significant difference in FC response was observed between the combined therapy group (70%) and the conventional therapy group (76.6%).
- Prucalopride demonstrated significant efficacy in improving functional upper GI symptoms (56%) and dysphagia (100%).
- Adverse effects were reported in 30% of patients, primarily abdominal cramps. A small subset (7%) with pre-existing mood disorders experienced mood worsening, including suicidal ideation in two cases.
Conclusions:
- Prucalopride is an effective treatment for concurrent upper GI symptoms and dysphagia in pediatric patients with functional constipation.
- The drug is generally well-tolerated in this population.
- Caution is advised for pediatric patients with pre-existing mood disorders due to potential mood exacerbation.
Introduction:
Pediatric prucalopride studies for treatment of gastrointestinal (GI) disorders have reported mixed results. We aimed to assess the safety and effectiveness of prucalopride in functional constipation (FC) with and without upper GI symptoms.
Methods:
Retrospective data on patients with FC receiving combined prucalopride and conventional therapy was compared with those receiving conventional therapy alone within 12 months. Thirty patients on combined therapy and those on conventional therapy were each matched on the basis of age, gender, race, and presence of fecal soiling. Response (complete, partial, or no resolution) was compared. Similarly, response to concurrent functional upper GI symptoms (postprandial pain, bloating, weight loss, vomiting, early satiety, or nausea) and dysphagia, as well as adverse effects, were evaluated in the combined group.
Results:
Mean age of 57 cases was 14.7 ± 4.9 years and 68% were female. Comorbidities included functional upper GI (UGI) symptoms (84%), dysphagia (12%), mood disorders (49%), and hypermobility spectrum disorder (37%). Unmatched cases reported 63% improvement to FC; response did not differ between the matched cohorts (70% versus 76.6%, p = 0.84). Cases showed a 56% improvement in functional UGI symptoms and 100% in dysphagia. Adverse effects were reported in 30%, abdominal cramps being most common. Four (7%) patients with a known mood disorder reported worsened mood, of which two endorsed suicidal ideation.
Conclusion:
Prucalopride efficaciously treated concurrent UGI symptoms and dysphagia in constipated pediatric patients and was overall well tolerated. Preexisting mood disorders seemed to worsen in a small subset of cases.
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