Clinical trial NCT06836362: Acupuncture for Children with Functional Constipation
Official title: Acupuncture for Children with Functional Constipation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Constipation (FC)
Keywords: functional constipation
child
acupuncture
children
DGBI
pilot study
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* 6-18 years of age
* meet the modified Rome IV criteria for FC (defined as meeting at least two of the following criteria during the 2-week run-in period despite receiving treatment with PEG with a minimum dose of 0.2 g/kg/day):

  1. Two or fewer spontaneous bowel movements (SBMs) per week (an SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use in the preceding 24 hours)
  2. History of excessive stool retention
  3. History of painful or hard bowel movements
  4. History of large-diameter stools
  5. Presence of a large fecal mass in the rectum
  6. At least 1 episode/week of incontinence after the acquisition of toileting skills
  7. History of large-diameter stools that may obstruct the toilet in toilet-trained children
* Insufficient symptom management despite at least three months of medical management (including education, non-pharmacological advice and laxatives) by a physician. Insufficient symptom management is defined as the presence of at least one of the Rome IV criteria for FC despite medical management by a physician.
* are treated with PEG with a minimum dose of 0.2 g/kg/day for a minimum of 1 month prior to inclusion in the study
* Written informed consent obtained from parents or guardians and all children ≥12 years.

Exclusion Criteria:

* A potential subject who meets any of the following criteria will be excluded from participation in this study:
* children with FC not treated with PEG with a minimum dose of 0.2g/kg/day during at least one month at the time of potential inclusion.
* Irritable bowel syndrome.
* Organic causes of constipation; e.g. celiac disease, pediatric intestinal pseudo-obstruction, hypothyroidism, spina bifida, anorectal malformations, or Hirschsprung disease.
* Significant chronic health conditions requiring specialty care (e.g. cardiac, pulmonary, hepatic, hematopoietic, renal, endocrine, or metabolic diseases, sickle cell disease, cerebral palsy) that could potentially impact the child's ability to participate or confound the results of the study.
* Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months.
* Gastrointestinal blood loss.
* Recurrent or unexplained fevers.
* Pregnancy.
* Smoking.
* History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy or hernia repairs.
* Concomitant use of drugs that are known to affect gastrointestinal motility.
* Established diagnoses of autism spectrum disorders.
* Major psychiatric disorders (bipolar disorder, schizophrenia, major depression) or a history of abuse.
* Severe needle-related anxiety.
* Rash or active local infection over an acupuncture point.
* Immunocompromised children (specifically inadequately regulated diabetes mellitus, active staphylococcal-related skin conditions)
* Clotting disorders or a recent history of thrombocytopenia.
* Children who previously received acupuncture for constipation.
* Children who currently participate in another clinical trial.

Primary outcomes:
measure: Primary outcome measure: feasibility
timeFrame: From enrollment until the end of the intervention period (at 10 weeks)
Secondary outcomes:
measure: Secondary outcome measure: Feasibility
timeFrame: From enrollment to the end of intervention (week 10) and follow-up (week 14)
measure: Secondary Outcome Measure: Safety (assessment of adverse events)
timeFrame: From first acupuncture treatment until last treatment (week 10) and after follow-up (week 14)
measure: Secondary Outcome Measure: Efficacy
timeFrame: From start of intervention until end of intervention (at week 10 and at follow-up (at week 14)
Other outcomes:
Locations:
Study officials:
References: