Background of the study: Functional constipation (FC) is common in children and poses a significant burden to patients, their families and the healthcare system. Pharmacological treatment mainly consists of oral osmotic laxatives. However, poor adherence to oral laxatives is known to be a common problem and patients often remain symptomatic despite pharmacological treatment. Many parents seek help in the form of complementary and integrative medicine. Acupuncture has been shown to relieve symptoms in adults with FC. However, published studies in children with FC are scarce and have important limitations. Objective of the study: To evaluate the feasibility, safety and potential efficacy of acupuncture in children with FC. The results of this study will be used to design a future randomized controlled trial (RCT). Study design: A prospective, non-randomized, multicenter, open-label pilot study. Intervention: Children will receive 8 acupuncture sessions during 10 weeks (1 session per week during 6 weeks, followed by 1 session every other week during 4 weeks). Concurrent pharmacological treatment with polyethylene glycol ≥ 0.2 g/kg/day will be maintained as initiated prior to participation in the study. Study population: 18 children (6-18 years old) with FC according to the Rome IV criteria.
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Primary outcome measure: feasibility
Timeframe: From enrollment until the end of the intervention period (at 10 weeks)