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

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ClinicalTrials.gov Identifier: NCT02854098
Recruitment Status : Unknown
Verified March 2017 by Andrzej Załęski, Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Andrzej Załęski, Medical University of Warsaw

Tracking Information
First Submitted Date July 16, 2016
First Posted Date August 3, 2016
Last Update Posted Date March 31, 2017
Study Start Date April 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2016)
The comorbidity of benign hypermobility joint syndrome and functional constipation in children (in %) [ Time Frame: April 2017 ]
The Hypermobility of the connective tissue as one of the etiological factors of functional constipation in children
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02854098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 31, 2016)
  • The comorbidity of BHJS and functional constipation, depending on age (in %) [ Time Frame: April 2017 ]
  • The comorbidity of BHJS and functional constipation, depending on gender (in %) [ Time Frame: April 2017 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children
Official Title The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children
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.

Detailed Description

Clinical question: Is there among patients with functional constipation increased percentage of children with Benign Hypermobility Joint Syndrome, compared with a population of healthy children? In discussion we would like to determine whether the excessive laxity of connective tissue can promote the development of functional constipation in children.

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 °)
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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

Condition
  • Benign Hypermobility Syndrome
  • Functional Constipation
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 31, 2016)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

First group:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Organic causes of constipation (anatomical abnormalities: narrowing of the anus or rectum, state after surgical correction of this anomalies)
  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:

Inclusion Criteria:

  1. Age 3 - 18 years.
  2. Without functional constipation
  3. Informed consent of patients and caregivers

Exclusion Criteria:

1 Lack of informed consent of patients and caregivers

Place: Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Poland

Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02854098
Other Study ID Numbers 1W33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Andrzej Załęski, Medical University of Warsaw
Study Sponsor Medical University of Warsaw
Collaborators Not Provided
Investigators
Study Chair: Piotr Albrecht, PhD Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date March 2017