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Prospective, non-randomised, open-label pilot trial assessing feasibility, safety and treatment success of acupuncture in children with functional constipation: ACU-PILOT study protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Bloem Michelle N, Baaleman Desiree F, Koppen Ilan J N, Vlieger Arine M, de Lorijn Fleur, Birch Stephen, Nieuwdorp Max, Benninga Marc A
Аннотация
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.
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.