Functional Constipation in ChildrenNCT06657313
Is Vitamin D Deficiency Linked to Functional Constipation In Children
An observational study of Functional Constipation in Children, run by Benha University at 1 site in Egypt.
Trial summary
Constipation is one of the most common causes of patient visits to pediatric clinics. Prevalence of constipation is estimated between 1.9-27.2% in the USA (Rasquin et al., 2006). In children aged <18 years, its prevalence was about 0.7-29.6%. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation in Children
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2024
- How long will I take part?
- 1 Month
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All pediatric patients who were diagnosed with chronic functional constipation according to Revised Rome IV criteria included in this study will be subjected to: * Demographic data upon admission including age, sex, weight, length, BMI, level of education of parents \& residency. * The following data will be collected from patients with chronic constipation: Nutritional history, frequency of defecation per day, history of painful or hard bowel movements, history of excessive stool retention, history of large diameter stools, presence of a large fecal mass in the rectum, history of fecal incontinence per week, history of large diameter stools that can obstruct the toilet, duration of the disease and treatment. * Clinical data including symptoms as constipation, abdominal pain and swelling and signs like abdominal distension. Diagnosis of Functional chronic constipation in pediatric was done according to the Revised Rome IV criteria
Who may be able to join
- All pediatric Patients from 6 to 16 years old who were diagnosed with chronic constipation in gastrointestinal and hepatology clinic, at Benha university Hospital according to revised Rome IV criteria will be consecutively recruited in this study.
- Sex- and age-matched approximate-health children will be recruited as a control group.
Who cannot join
- 1)- Age < 6 years and > 16 years old. 2)- Children with any chronic medical disease. 3)- Children who receive any medications. 4)- Children with organic causes of constipation such as anal fissure, stenosis or stricture, inflammatory bowel disease and intestinal malabsorption.
Trial locations and contacts
1 site in 1 country.
About this study
Constipation is one of the most common causes of patient visits to pediatric clinics. Prevalence of constipation is estimated between 1.9-27.2% in the USA (Rasquin et al., 2006).
In children aged <18 years, its prevalence was about 0.7-29.6%. Untreated constipation may cause fecal impaction and fecal soiling5 which are seen in about 1-3% of children (Bulloch and Tenenbein, 2002).
Read more
Constipation may cause gastrointestinal problems such as abdominal pain, anal pruritus, rectal bleeding, and anorexia or non-gastrointestinal complications such as urinary problems (Dehghani et al., 2015).
Functional constipation is defined as constipation without an organic etiology and is diagnosed according to the Rome criteria1-3. The symptom- based Rome criteria were first developed for adults in 1989 during a consensus meeting of experts in the field of functional gastrointestinal disorders. These criteria have been updated several times and are now internationally acknowledged and used for both research and clinical purposes. The revised Rome IV criteria- for childhood and adult functional constipation were published in 2016 (Benninga et al., 2016), (Hyams et al., 2016), (Lacy et al., 2016).
Functional constipation, a common disorder in all age groups, shows some similarities in children and adults, but important differences exist regarding epidemiology, symptomatology, pathophysiology, diagnostic workup and therapeutic management. In this research, we hypothesized that serum vitamin D deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.
Read the detailed description
In this research, we hypothesized that serum vitamin D deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.
- Conditions
- Functional Constipation in Children
- Keywords
- Vitamin D Deficiency, Functional constipation, Children
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level in Children with functional constipation
Investigate the relationship between serum 25-hydroxyvitamin D levels and functional chronic constipation in children.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation in ChildrenStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohammed El-Rebigi, MD, Benha University
- Investigators
- Amany M. El-Rebigi, PhD, MD, Principal investigator, lecturer of pediatric and neonatology, Faculty of medicine, Benha UniversityRasha M. Zakaria, PhD, MD, Principal investigator, lecturer of pediatric and neonatology, Faculty of medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657313
- Sponsor's protocol ID
- Rc 18-5-2024
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Vitamin D Deficiency Linked to Functional Constipation In Children
- ClinicalTrials.gov ID
- NCT06657313
- Acronym / sponsor ID
- Rc 18-5-2024
- Conditions
- Functional Constipation in Children
- Keywords
- Vitamin D Deficiency, Functional constipation, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Oct 2024 (actual)
- 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.
Constipation is one of the most common causes of patient visits to pediatric clinics. Prevalence of constipation is estimated between 1.9-27.2% in the USA (Rasquin et al., 2006).
In children aged <18 years, its prevalence was about 0.7-29.6%. Untreated constipation may cause fecal impaction and fecal soiling5 which are seen in about 1-3% of children (Bulloch and Tenenbein, 2002).
Constipation may cause gastrointestinal problems such as abdominal pain, anal pruritus, rectal bleeding, and anorexia or non-gastrointestinal complications such as urinary problems (Dehghani et al., 2015).
Functional constipation is defined as constipation without an organic etiology and is diagnosed according to the Rome criteria1-3. The symptom- based Rome criteria were first developed for adults in 1989 during a consensus meeting of experts in the field of functional gastrointestinal disorders. These criteria have been updated several times and are now internationally acknowledged and used for both research and clinical purposes. The revised Rome IV criteria- for childhood and adult functional constipation were published in 2016 (Benninga et al., 2016), (Hyams et al., 2016), (Lacy et al., 2016).
Functional constipation, a common disorder in all age groups, shows some similarities in children and adults, but important differences exist regarding epidemiology, symptomatology, pathophysiology, diagnostic workup and therapeutic management. In this research, we hypothesized that serum vitamin D deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.
Detailed description
In this research, we hypothesized that serum vitamin D deficiency could be associated with chronic functional constipation in children secondary to delayed transit intestinal time and consequently we will investigate this relationship and the related psychological aspects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All pediatric patients who were diagnosed with chronic functional constipation according to Revised Rome IV criteria included in this study will be subjected to: * Demographic data upon admission including age, sex, weight, length, BMI, level of education of parents \& residency. * The following data will be collected from patients with chronic constipation: Nutritional history, frequency of defecation per day, history of painful or hard bowel movements, history of excessive stool retention, history of large diameter stools, presence of a large fecal mass in the rectum, history of fecal incontinence per week, history of large diameter stools that can obstruct the toilet, duration of the disease and treatment. * Clinical data including symptoms as constipation, abdominal pain and swelling and signs like abdominal distension. Diagnosis of Functional chronic constipation in pediatric was done according to the Revised Rome IV criteria
Key inclusion criteria (2 listed)
- All pediatric Patients from 6 to 16 years old who were diagnosed with chronic constipation in gastrointestinal and hepatology clinic, at Benha university Hospital according to revised Rome IV criteria will be consecutively recruited in this study.
- Sex- and age-matched approximate-health children will be recruited as a control group.
Key exclusion criteria (1 listed)
- 1)- Age < 6 years and > 16 years old. 2)- Children with any chronic medical disease. 3)- Children who receive any medications. 4)- Children with organic causes of constipation such as anal fissure, stenosis or stricture, inflammatory bowel disease and intestinal malabsorption.
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
Vitamin D level in Children with functional constipation
Time frame: 6 months
Investigate the relationship between serum 25-hydroxyvitamin D levels and functional chronic constipation in children.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- 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.
Amany M. El-Rebigi, PhD, MD principal investigator
lecturer of pediatric and neonatology, Faculty of medicine, Benha University
Rasha M. Zakaria, PhD, MD principal investigator
lecturer of pediatric and neonatology, Faculty of medicine, Benha University
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 Functional Constipation in Children, run by Benha University at 1 site in Egypt.
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 2 inclusion and 1 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 24 Oct 2024. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D level in Children with functional constipation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.