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Acupuncture for Children with Functional Constipation

NCT06836362 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-20

No results posted yet for this study

Summary

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.

Conditions

  • Functional Constipation (FC)

Interventions

OTHER

Acupuncture treatment

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). At each acupuncture session, the acupuncturist records the patient's bowel habits, gastrointestinal symptoms and the use of escape medication during the period between sessions. After 3, 6 and 8 acupuncture treatments respectively, patients will visit the research team after they receive acupuncture to evaluate adverse events. After completion of these 10 weeks, an acupuncture-free follow-up period of 4 weeks commences. The follow-up period will be used to investigate if and how long effects of the intervention will persist. During the intervention period and the follow-up period, escape medication (bisacodyl or enemas) is allowed under the same conditions as during the run-in period.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2026-05-31
Completion
2026-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06836362 on ClinicalTrials.gov