Peer-reviewed article
Prospective, non-randomised, open-label pilot trial assessing feasibility, safety and treatment success of acupuncture in children with functional constipation: ACU-PILOT study protocol.
Bloem MN, Baaleman DF, Koppen IJN, Vlieger AM, de Lorijn F et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a study protocol for a pilot trial testing whether acupuncture can help children aged 6-18 years with functional constipation. The study will give 8 acupuncture sessions over 10 weeks to children who continue taking standard laxative medications. Researchers will measure whether the treatment is feasible to deliver, safe, and whether it helps children stop meeting the medical criteria for constipation. The study aims to fill a gap because acupuncture has shown promise in adults but there is very little research in children.
Key points
- Functional constipation is common in children and often does not respond well to standard laxative treatment
- The study is a non-randomised, open-label pilot design with a target attrition rate of at least 70% for feasibility
- Children will receive 8 acupuncture sessions over 10 weeks while continuing their existing polyethylene glycol medication
- Primary feasibility endpoints include attrition rate, consent rate, patient/parent satisfaction and personnel requirements
- Efficacy will be measured by whether children no longer meet Rome IV criteria for functional constipation, plus defecation frequency, stool consistency, pain, incontinence and quality of life
Limitations
This is a protocol paper only, not yet reporting results, so no outcome data are available. The open-label, non-randomised design means results cannot show causation or rule out placebo effects, and the small pilot sample will limit generalisability.
Abstract
Introduction Functional constipation (FC) is prevalent among children and often persists despite standard pharmacological treatment with oral laxatives. Many parents turn to complementary therapies, including acupuncture, which has been shown to relieve symptoms in adults with FC. However, studies in children with FC are scarce and have important limitations. This study will evaluate the feasibility, safety and potential efficacy of acupuncture for children with FC. Methods and analysis Prospective, non-randomised, open-label pilot study in children with FC (6-18 years). Participants will undergo eight acupuncture sessions over 10 weeks. Concurrent pharmacological treatment with polyethylene glycol (≥0.2 g/kg/day) will continue as initiated prior to enrolment. The primary endpoint is feasibility, defined by an attrition rate of ≥70%. Secondary feasibility endpoints include consent rate, patient/parent satisfaction and personnel requirements. Safety will be assessed by systematic monitoring of adverse events. Efficacy endpoints include treatment success, defined as no longer meeting the Rome IV criteria for FC at the end of the intervention period, as well as defecation frequency, stool consistency, painful defecation, faecal incontinence frequency, abdominal pain, medication use and quality of life, based on a previously published core outcome set. Ethics and dissemination Ethical approval was provided by the Medical Ethics Committee of Amsterdam UMC (Netherlands; NL87083.018.24). Results will be published in peer-reviewed journals and presented to scientific and consumer audiences. Trial registration numbers NCT06836362 and NL-OMON57236.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Eight acupuncture sessions delivered over 10 weeks, with concurrent continuation of polyethylene glycol medication
- Population
- Children aged 6-18 years with functional constipation
Key finding
Study is a protocol; no results yet available
MN et al. · Europe PMC · 11 Nov 2025