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MobCon
Sponsor study identifier
observational
400
1 country
1
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2016
Actual (reported)August 3, 2016
Actual (reported)June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
n = 200 patients with functional constipation examined for BHJS age 3 -18 years meet inclusion criteria, do not fulfill exclusion criteria
n = 200 patient with functional constipation examined for BHJS age 3 -18 years meet inclusion criteria, do not fulfill exclusion criteria
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
Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091, Poland
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.
Piotr Albrecht, PhD
Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
First Submitted
July 16, 2016
First Posted
August 3, 2016
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2017
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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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 31, 2017
Record last verified: 2017-03
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