The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children

NCT02854098 | Unknown

• 1 other identifier: 1W33
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Benign Hypermobility Joint Syndrome is a group of inherited abnormalities in the structure of connective tissues, manifested by disturbances in the proportion of collagen. The main symptoms of this syndrome include: laxity of joint capsules and ligaments, hypermobility of the joints, as well as numerous disturbances in the functioning of internal organs that contain connective tissue, including the gastrointestinal tract. Hypermobility of joints affects approximately 10% of the population of Western countries, is more common in small children and female. Modified Beighton scale is the basic scale for assessing hypermobility of joints. The scale (as assessed using the goniometer) is a reliable tool for the evaluation of excessive laxity of the connective tissue in children. 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.

Conditions

Benign Hypermobility Syndrome; Functional Constipation

Keywords

BHJS, constipation

Outcome Measures

Primary Outcomes (1)

• The comorbidity of benign hypermobility joint syndrome and functional constipation in children (in %)

  The Hypermobility of the connective tissue as one of the etiological factors of functional constipation in children

  April 2017

Secondary Outcomes (2)

• The comorbidity of BHJS and functional constipation, depending on age (in %)

  April 2017

• The comorbidity of BHJS and functional constipation, depending on gender (in %)

  April 2017

Study Arms (2)

with functional constipation

n = 200 patients with functional constipation examined for BHJS age 3 -18 years meet inclusion criteria, do not fulfill exclusion criteria

without functional constipation

n = 200 patient with functional constipation examined for BHJS age 3 -18 years meet inclusion criteria, do not fulfill exclusion criteria

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

2 groups, n = 400 (200 patients each group) age 3 - 18 years. first group - with functional constipation second group - without functional constipation Each patient meet inclusion criteria, do not fulfill exclusion criteria

You may qualify if:

• Age 3 - 18 years.
• Diagnosed functional constipation (on the basis of III Rome Criteria)
• Informed consent of patients (if more than 16 years) and caregivers

You may not qualify if:

• Organic causes of constipation (anatomical abnormalities: narrowing of the anus or rectum, state after surgical correction of this anomalies)
• Metabolic and gastrological diseases in anamnesis: hypothyroidism, hypercalcemia, hypokalemia, cystic fibrosis, diabetes, celiac disease
• Neuropathies: defects and injures of the spinal cord, encephalopathies
• Neuromuscular disorders: Hirschsprung's disease, intestinal neuronal dysplasia, visceral myopathies and neuropathies
• Abnormal abdominal musculature: Down syndrome;
• The use of drugs (opioids, phenobarbital, sucralfate, antidepressants, anticholinergic, sympathomimetic)
• Lack of informed consent of patients (if more than 16 years) and caregivers
• Second group:
• Age 3 - 18 years.
• Without functional constipation
• Informed consent of patients and caregivers
• Lack of informed consent of patients and caregivers
• Place: Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Poland

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

Related Publications (7)

• Mirska A, Kalinowska AK, Topór E, et al. Łagodny zespół hipermobilności stawów (BHJS). Neurologia Dziecięca 2011; 41; 135-140.

  BACKGROUND

• 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.

  PMID: 25151198 BACKGROUND

• 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.

  PMID: 24440216 BACKGROUND

• 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.

  PMID: 10914867 BACKGROUND

• 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.

  PMID: 20850761 BACKGROUND

• 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.

  PMID: 19840271 BACKGROUND

• 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.

  PMID: 20618831 BACKGROUND

Related Links

• Rome III Criteria

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Piotr Albrecht, PhD

  Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Andrzej Załęski, MD

CONTACT

+48 600 982 185; andrzejzaleski84@wp.pl

Agnieszka Gawrońska, PhD

CONTACT

+48 22 317 94 51; gastroenterologia@spdsk.edu.pl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 16, 2016
• First Posted: August 3, 2016
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)