Benign Hypermobility SyndromeMobConNCT02854098
The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children
An observational study of Benign Hypermobility Syndrome and Functional Constipation, run by Medical University of Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Hypermobility Syndrome, Functional Constipation
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2015to Oct 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
- Age 3 - 18 years.
- Without functional constipation
- Informed consent of patients and caregivers
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Andrzej Załęski, MD, + 48 600982185, andrzejzaleski84@wp.pl
About this study
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.
Read the 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:
- Anamnesis and physical examination of the patient
- The consent of the parents and the patient (if > 15 years) to participate in the study
- Determining whether the patient meets the criteria for inclusion in the study
- 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
- In patients classified to the study, the degree of laxity of the connective tissue will be assessed in the basis of modified Beighton scale
- 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
- 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:
- Two or fewer defecations per week
- At least one episode/week of incontinence after the acquisition of toileting skills
- History of excessive stool retention
- History of painful or hard bowel movements
- Presence of a large fecal mass in the rectum
- 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:
- Placing flat hands on the floor with straight legs
- Left knee bending backward (>10 °)
- Right knee bending backward (>10 °)
- Left elbow bending backward (>10 °)
- Right elbow bending backward (>10 °)
- Left thumb touching the forearm
- Right thumb touching the forearm
- Left little finger bending backward (>90 °)
- Right little finger bending backward (>90 °)
- Keywords
- BHJS, constipation
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: April 2017
Secondary outcomes (2)
The comorbidity of BHJS and functional constipation, depending on age (in %)
Measured: April 2017
The comorbidity of BHJS and functional constipation, depending on gender (in %)
Measured: April 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Benign Hypermobility SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Załęski, Medical University of Warsaw
- Investigators
- Piotr Albrecht, PhD, Study chair, Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854098
- Sponsor's protocol ID
- 1W33
- Acronym
- MobCon
- Status last verified
- Mar 2017
- First submitted
- 16 Jul 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25151198Fikree 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.
PubMed 24440216Grahame 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.
PubMed 10914867Smits-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.
PubMed 20850761Zarate 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.
PubMed 19840271Mohammed 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.
PubMed 20618831
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comorbidity of Benign Hypermobility Joint Syndrome and Functional Constipation in Children
- ClinicalTrials.gov ID
- NCT02854098
- Acronym / sponsor ID
- MobCon / 1W33
- Keywords
- BHJS, constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Anamnesis and physical examination of the patient
- The consent of the parents and the patient (if > 15 years) to participate in the study
- Determining whether the patient meets the criteria for inclusion in the study
- 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
- In patients classified to the study, the degree of laxity of the connective tissue will be assessed in the basis of modified Beighton scale
- 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
- 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:
- Two or fewer defecations per week
- At least one episode/week of incontinence after the acquisition of toileting skills
- History of excessive stool retention
- History of painful or hard bowel movements
- Presence of a large fecal mass in the rectum
- 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:
- Placing flat hands on the floor with straight legs
- Left knee bending backward (>10 °)
- Right knee bending backward (>10 °)
- Left elbow bending backward (>10 °)
- Right elbow bending backward (>10 °)
- Left thumb touching the forearm
- Right thumb touching the forearm
- Left little finger bending backward (>90 °)
- Right little finger bending backward (>90 °)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
- Age 3 - 18 years.
- Without functional constipation
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- BackgroundMirska A, Kalinowska AK, Topór E, et al. Łagodny zespół hipermobilności stawów (BHJS). Neurologia Dziecięca 2011; 41; 135-140.
- Background: PubMed 25151198Kovacic 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.
- Background: PubMed 24440216Fikree 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.
- Background: PubMed 10914867Grahame 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.
- Background: PubMed 20850761Smits-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.
- Background: PubMed 19840271Zarate 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.
- Background: PubMed 20618831Mohammed 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.
- Rome III CriteriaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Albrecht, PhD study chair
Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Hypermobility Syndrome and Functional Constipation, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Załęski, MD (+48 600 982 185, andrzejzaleski84@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comorbidity of benign hypermobility joint syndrome and functional constipation in children (in %) (time frame: April 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854098, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.