constipation functional constipation
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Other feasibility endpoints include: consent rate, patient and parent satisfaction and required personnel capacity. Safety endpoints: adverse events and serious adverse events will be evaluated. Treatment success is the main efficacy endpoint, this definition is based on the Rome IV criteria; a child who no longer fulfills the Rome IV criteria at the end of the intervention period is considered successfully treated. Other efficacy endpoints are based on a previously published core outcome set and include: defecation frequency, stool consistency, painful defecation, fecal incontinence frequency, abdominal pain, use of (escape) medication and quality of life. | — |
Countries
Netherlands
Outcome results
None listed