Prospective, non-randomised, open-label pilot trial assessing feasibility, safety and treatment success of acupuncture in children with functional constipation: ACU-PILOT study protocol.

Researchers in the Netherlands are launching a pilot study to test whether acupuncture can help children with functional constipation (FC), a common condition where children have difficulty with bowel movements despite taking laxatives. Many children continue to struggle with constipation even when using standard medications like polyethylene glycol, leading parents to seek alternative treatments. While acupuncture has shown promise for adults with constipation, very few studies have examined its use in children.

This study will enroll children ages 6-18 who have functional constipation and will provide them with eight acupuncture sessions over 10 weeks. All participants will continue taking their regular laxative medications during the study. The researchers want to determine three main things: whether the treatment is feasible (can children complete the full course?), whether it's safe, and whether it might actually work to relieve constipation symptoms.

The study will track several outcomes including how often children have bowel movements, stool consistency, pain during defecation, accidents, abdominal pain, medication needs, and overall quality of life. Success will be defined as no longer meeting the diagnostic criteria for functional constipation by the end of treatment. The researchers will also monitor any side effects and ask parents and children about their satisfaction with the treatment.

This is a pilot study, meaning it's a small preliminary investigation designed to test whether a larger study would be worthwhile. The results will help determine if acupuncture could be a useful complementary treatment for children struggling with chronic constipation. If you're considering acupuncture for your child, consult with a licensed acupuncturist experienced in pediatric care.

This prospective, non-randomized, open-label pilot study (NCT06836362) will assess the feasibility, safety, and potential efficacy of acupuncture for pediatric functional constipation (FC) in children aged 6-18 years. Participants will receive eight acupuncture sessions over 10 weeks while continuing concurrent polyethylene glycol therapy (≥0.2 g/kg/day). The primary feasibility endpoint is an attrition rate of ≥70%, with secondary measures including consent rate, patient/parent satisfaction, and personnel requirements. Safety will be monitored through systematic adverse event tracking. Efficacy endpoints include treatment success defined as no longer meeting Rome IV criteria for FC, plus defecation frequency, Bristol stool consistency, painful defecation, fecal incontinence frequency, abdominal pain, medication use, and quality of life measures based on a published core outcome set. This pilot study addresses a significant gap in pediatric gastroenterology research, as evidence for acupuncture in pediatric FC remains limited despite growing parental interest in complementary therapies. Results will inform the design of future randomized controlled trials.