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).
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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.
Study objective
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 burden and risks
During this study, patients will visit the hospital or acupuncture facility in
Amsterdam 10 times in 14 weeks. They will receive 8 acupuncture treatments.
Patients/parents are asked to fill out several questionnaires throughout the
study, including questions about defecation frequency, adverse events, quality
of life, school absenteeism and treatment satisfaction. Outcomes of systematic
reviews on the efficacy and safety of acupuncture in pediatric practice
conclude that acupuncture treatment is well-tolerated and the majority of
reported adverse events associated with pediatric needle acupuncture are
infrequent and mild. Randomized sham-controlled studies in adults with FC
report low adverse event rates in both sham and acupunctures groups, all
reported adverse events were mild and transient. In a recent meta-analysis
evaluating the safety of acupuncture in adults with FC, no significant
difference with regard to safety was found between acupuncture and treatment
with polyethylene glycol, and acupuncture was considered safer than lactulose
and mosapride.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87083.018.24 |