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Clinical Trial NCT06836362 (ACU-PILOT) for Functional Constipation (FC) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Acupuncture for Children with Functional Constipation (ACU-PILOT) 18 Randomized Open-Label

Not yet recruiting
Clinical Trial NCT06836362 (ACU-PILOT) is an interventional study for Functional Constipation (FC) and is currently not yet recruiting. Enrollment is planned to begin on 20 February 2025 and continue until the study accrues 18 participants. Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), this study is expected to complete by 1 October 2026. The latest data from ClinicalTrials.gov was last updated on 20 February 2025.
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 com...

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Official Title

Acupuncture for Children with Functional Constipation: a Pilot Study

Conditions
Functional Constipation (FC)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • ACU-PILOT
  • NL87083.018.24
NCT ID Number
NCT06836362
Start Date (Actual)
2025-02-20
Last Update Posted
2025-02-20
Completion Date (Estimated)
2026-10
Enrollment (Estimated)
18
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
functional constipation
child
acupuncture
children
DGBI
pilot study
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherSingle-arm study. The intervention consists of acupuncture treatments
This is an open-label, non-randomized single-arm study. The intervention consists of acupuncture (see description under intervention). Throughout the study duration, participants will maintain their therapeutic recommendations related to treating constipation (PEG at the dosage prior to entering the study, minimum of 0.2 g/kg/day, education and non-pharmacological advice as previously described by the medical team in...Show More
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 t...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Primary outcome measure: feasibility
The primary endpoint is feasibility: a future RCT using this same intervention protocol will be deemed feasible if the pilot study renders an attrition rate ≥70% (i.e. ≥70% of patients completing the pilot study while attending ≥75% of scheduled acupuncture sessions).
From enrollment until the end of the intervention period (at 10 weeks)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Secondary outcome measure: Feasibility
Secondary endpoints to determine feasibility include consent rate, patient and parent satisfaction with acupuncture treatment (measured at t=6, t=10 and t=14 \[5-point-Likert scale\]) and assessment of required personnel capacity for a future RCT
From enrollment to the end of intervention (week 10) and follow-up (week 14)
Secondary Outcome Measure: Safety (assessment of adverse events)
The occurrence of adverse events (AE) is assessed at each research nurse visit (t=3, t=6, t=10, t=14). The occurrence of the following pre-determined adverse events are assessed: needle-related pain, local redness/irritation, hematomas, headache, fainting/syncope, sedation, neuropathy. For each patient-reported AE, severity (mild, moderate, or severe) and relation to acupuncture treatment (unrelated or possibly, probably, or definitely related) are determined.
From first acupuncture treatment until last treatment (week 10) and after follow-up (week 14)
Secondary Outcome Measure: Efficacy
The endpoint for efficacy is treatment success, based on the Rome IV criteria (Table 1): a child who fulfils the Rome IV criteria for FC prior to enrolment into the trial and no longer fulfils the Rome IV criteria at the end of the trial period is considered successfully treated. The endpoints, including quality of life and school absence, are based on a previously published core outcome set and include: * Defecation frequency (number of bowel movements/week, excluding fecal incontinence episodes) * Stool consistency (Bristol Stool Scale) * Painful defecation (yes/no) * Fecal incontinence frequency (episodes/week) * Withholding behavior (yes/no) * Abdominal pain (yes/no, VAS score) * Number of spontaneous bowel movements (\>24h after escape medication) * Time between acupuncture and defecation * Number of bowel movements \<24h after acupuncture * Frequency of use of escape medication * Time between escape medication and defecation * Number of bowel movements \<24h after escape med.
From start of intervention until end of intervention (at week 10 and at follow-up (at week 14)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
6 Years
Eligible Sexes
All

  • 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.

  • 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.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) logoAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Responsible Party
M.A. Benninga, Principal Investigator, Prof. Dr. M.A. Benninga, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
No contact data.