The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children
NCT ID: NCT02854098
Last Updated: 2017-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2015-04-30
2017-10-31
Brief Summary
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Functional constipation is a very common condition, affecting approximately 3-5% of children and adolescents, with peak onset between 2 and 4 years of age. The etiology of this disorder is multifactorial, and till day it is still exactly unknown why some children develop constipation, while in others we can observe the correct scheme of defecation. Suspending stool enhances the retention of fecal masses, which subsequently causes painful defecation. Diagnosis is based on history, clinical symptoms and physical examination. Increased susceptibility of the wall of the distal gastrointestinal tract could explain the predisposition of some children to retain fecal masses and the development of constipation.
Due to the unclear etiology of functional constipation, it seems reasonable to conduct a study assessing whether excessive laxity of connective tissue (assessed on the basis of the hypermobility of the joints) facilitates the accumulation of stool in the large intestine, and so is the one of the reasons leading to development of functional constipation in children.
Detailed Description
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Description of the study:
1. Anamnesis and physical examination of the patient
2. The consent of the parents and the patient (if \> 15 years) to participate in the study
3. Determining whether the patient meets the criteria for inclusion in the study
4. The exclusion of patients meeting the exclusion criteria for the study - on the basis of anamnesis and physical examination (including neurological) and diagnostic tests (biochemical and electrolyte TSH -, Na, K, Ca, P, Mg), if indicated
5. In patients classified to the study, the degree of laxity of the connective tissue will be assessed in the basis of modified Beighton scale
6. In the control group - patients without constipation in an interview - the degree of laxity of the connective tissue will be assessed in the basis of modified Beighton scale
7. Evaluation of the results.
Rome III Criteria Functional Constipation
Diagnostic criteria must include one month in children up to 4 years of age and two months in older children(with insufficient criteria for diagnosis of IBS) of at least two of the following:
1. Two or fewer defecations per week
2. At least one episode/week of incontinence after the acquisition of toileting skills
3. History of excessive stool retention
4. History of painful or hard bowel movements
5. Presence of a large fecal mass in the rectum
6. History of large diameter stools which may obstruct the toilet Accompanying symptoms may include irritability, decreased appetite, and/or early satiety. The accompanying symptoms disappear immediately following passage of a large stool.
Modified Beighton scale Hypermobility of joints indicates ≥ 4 points out of 9 possible.
The Beighton score is measured by adding 1 point for each of the following:
1. Placing flat hands on the floor with straight legs
2. Left knee bending backward (\>10 °)
3. Right knee bending backward (\>10 °)
4. Left elbow bending backward (\>10 °)
5. Right elbow bending backward (\>10 °)
6. Left thumb touching the forearm
7. Right thumb touching the forearm
8. Left little finger bending backward (\>90 °)
9. Right little finger bending backward (\>90 °)
Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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with functional constipation
n = 200 patients with functional constipation examined for BHJS age 3 -18 years meet inclusion criteria, do not fulfill exclusion criteria
No interventions assigned to this group
without functional constipation
n = 200 patient with functional constipation examined for BHJS age 3 -18 years meet inclusion criteria, do not fulfill exclusion criteria
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed functional constipation (on the basis of III Rome Criteria)
3. Informed consent of patients (if more than 16 years) and caregivers
1. Age 3 - 18 years.
2. Without functional constipation
3. Informed consent of patients and caregivers
Exclusion Criteria
2. Metabolic and gastrological diseases in anamnesis: hypothyroidism, hypercalcemia, hypokalemia, cystic fibrosis, diabetes, celiac disease
3. Neuropathies: defects and injures of the spinal cord, encephalopathies
4. Neuromuscular disorders: Hirschsprung's disease, intestinal neuronal dysplasia, visceral myopathies and neuropathies
5. Abnormal abdominal musculature: Down syndrome;
6. The use of drugs (opioids, phenobarbital, sucralfate, antidepressants, anticholinergic, sympathomimetic)
7. Lack of informed consent of patients (if more than 16 years) and caregivers
Second group:
1 Lack of informed consent of patients and caregivers
Place: Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Poland
3 Years
18 Years
ALL
Yes
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Andrzej Załęski
M.D.
Principal Investigators
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Piotr Albrecht, PhD
Role: STUDY_CHAIR
Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
Locations
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Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Andrzej Załęski, MD
Role: primary
References
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Mirska A, Kalinowska AK, Topór E, et al. Łagodny zespół hipermobilności stawów (BHJS). Neurologia Dziecięca 2011; 41; 135-140.
Kovacic K, Chelimsky TC, Sood MR, Simpson P, Nugent M, Chelimsky G. Joint hypermobility: a common association with complex functional gastrointestinal disorders. J Pediatr. 2014 Nov;165(5):973-8. doi: 10.1016/j.jpeds.2014.07.021. Epub 2014 Aug 20.
Fikree A, Grahame R, Aktar R, Farmer AD, Hakim AJ, Morris JK, Knowles CH, Aziz Q. A prospective evaluation of undiagnosed joint hypermobility syndrome in patients with gastrointestinal symptoms. Clin Gastroenterol Hepatol. 2014 Oct;12(10):1680-87.e2. doi: 10.1016/j.cgh.2014.01.014. Epub 2014 Jan 16.
Grahame R, Bird HA, Child A. The revised (Brighton 1998) criteria for the diagnosis of benign joint hypermobility syndrome (BJHS). J Rheumatol. 2000 Jul;27(7):1777-9. No abstract available.
Smits-Engelsman B, Klerks M, Kirby A. Beighton score: a valid measure for generalized hypermobility in children. J Pediatr. 2011 Jan;158(1):119-23, 123.e1-4. doi: 10.1016/j.jpeds.2010.07.021. Epub 2010 Sep 17.
Zarate N, Farmer AD, Grahame R, Mohammed SD, Knowles CH, Scott SM, Aziz Q. Unexplained gastrointestinal symptoms and joint hypermobility: is connective tissue the missing link? Neurogastroenterol Motil. 2010 Mar;22(3):252-e78. doi: 10.1111/j.1365-2982.2009.01421.x. Epub 2009 Oct 15.
Mohammed SD, Lunniss PJ, Zarate N, Farmer AD, Grahame R, Aziz Q, Scott SM. Joint hypermobility and rectal evacuatory dysfunction: an etiological link in abnormal connective tissue? Neurogastroenterol Motil. 2010 Oct;22(10):1085-e283. doi: 10.1111/j.1365-2982.2010.01562.x. Epub 2010 Jul 5.
Related Links
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Rome III Criteria
Other Identifiers
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1W33
Identifier Type: -
Identifier Source: org_study_id