Constipation Chronic IdiopathicNCT06082622
Evaluation of the Triple Management Program in the Management of Functional Chronic Constipation in Children
A study testing laxatives in people with Constipation Chronic Idiopathic, run by Minia University.
Trial summary
Abstract Background: Chronic constipation is a common disease in children, 3% all children visit gastroenterology clinics with different types and complains. It is very harsh, time consuming and psychological problems to a child and all his family members. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation Chronic Idiopathic
- What is being tested?
- laxatives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Apr 2019
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All types of Constipations and all ages are distributed equally in the two Groups
Who cannot join
- surgically treated
About this study
Abstract Background: Chronic constipation is a common disease in children, 3% all children visit gastroenterology clinics with different types and complains. It is very harsh, time consuming and psychological problems to a child and all his family members.
Objective: To find a simple and effective training method that manages the bowel habits intervals both easy and effective for both child and parents.
Patients and methods: A training program for 18 weeks in 180 children with follow up every three months for 3 years between March 2016 and April 2019. Two groups were assembled, Group (A) with 90 children managed by the 3 Role program and Group (B) formed of the other 90 children treated with traditional guidelines. All types of functional Constipations and all ages are distributed equally in the two Groups. The Parents were taught to Hang a Sign Saying (One Bowel habit by third day at least) and then follow the Triple method program for 18 weeks. First follow up is on the 3rd week. The triple axis program is working on mental, colon elasticity and fecal consistency. The Mental axis is done by bowel interval sets in fixed 3 times for 10 minutes in each, Colon contents by certain diet protocol and colon motility and elasticity by drugs.
Read the detailed description
- Introduction Functional constipation (FC) is a common problem in children, with an estimated worldwide incidence of 9.5% . If there is no underlying organic reason, which is the case in up to 95% of children, constipation is classified as FC. The etiology of the 5% of cases with an organic origin range from metabolic to endocrine problems to Hirschsprung disease, anorectal malformations, and neuromuscular diseases. To diagnose Constipation in a child clinically, it is currently based on the pediatric diagnostic Rome IV criteria, Figure 1. Constipation poses a significant burden on both children and their family and is associated with a reduced quality of life, diminished academic performances and psychological problems including aggression, anxiety, depression, and altered emotional reactivity. Moreover, constipation is common in children with behavioral disorders, such as attention deficit hyperactivity disorder and autism spectrum disorders . Symptoms of FC may persist into adulthood despite adequate laxative treatment. The pathophysiology of constipation is multifactorial and incompletely understood. In more than 90 % of the cases, there is no organic explanation for the symptoms. Genetic predisposition, low-socio economic status, inadequate daily fiber intake, insufficient fluid intake, and immobility have been proposed as factors leading to FC. The most encountered etiological factor in children is withholding behavior, usually occurring after experiencing a painful or frightening evacuation of stools. Rome III criteria are commonly used to define functional constipation. Children with developmental age of at least 4 years must fulfill two or more of the following criteria. They should have insufficient criteria for diagnosis of irritable bowel syndrome. The criteria must be fulfilled at least once per week for at least 2 months before diagnosis. There should be no evidence of an organic disease explaining the symptoms .
- Two or fewer defecations in the toilet per week.
- At least one episode of fecal incontinence per week.
- History of retentive posturing or excessive volitional stool retention.
- History of painful or hard bowel movements.
- Presence of a large fecal mass in the rectum.
- History of large diameter stools. Almost identical criteria have been defined for infants and toddlers. Those criteria should be fulfilled for at least 1 month .
- Treatment regimens Conventional treatment of children with Functional Constipation involves non-pharmacological interventions (education, toilet training, defecation diary, and reward system) in combination with pharmacological interventions such as oral laxatives, of which poly-ethylene glycol is the first-line drug of choice.
Alternative treatment options for children with intractable constipation are limited and include anal sphincter botulinum toxin injections, trans anal irrigation, antegrade continent enemas (ACE), and, in rare cases, sacral nerve stimulation (SNS) and partial or total surgical resection of the colon15. and is frequently associated with fecal incontinence. In pediatrics, fecal incontinence has been defined as the voluntary or involuntary passage of feces into the underwear or in socially inappropriate places, in a child with a developmental age of at least 4 years. It has been suggested that in otherwise healthy children, fecal incontinence is secondary to 'overflow', and therefore results from the presence of constipation . This review aims to find a simple and effective training method that manages the bowel habits intervals both easy and effective for both child and parents. The exact prevalence of functional fecal incontinence associated with stool retention varies.
- Methodology A training program for 18 weeks in 180 children with follow up every three months for 3 years between March 2016 and April 2019. Two groups were assembled, Group (A) formed of the other 90 children treated with the 3 role program and Group (B) with 90 children managed by the previously mentioned traditional guidelines. All types of Constipations and all ages are distributed equally in the two Groups. The Parents in Group A were thought to Hang a Sign of (One Bowel habit by third day at least) and then follow the triple method program for 3 months. First follow up is on the 3rd week. The triple axis program is working on Psychic and mental axis, colon to retain its elasticity and fecal consistency.
- The Mental axis (Gut-Brain interaction)
- Habit timing training: It is done by bowel interval sets in fixed 3 times for 10-15 minutes of each, the preferred timing for training is just after breakfast, lunch and one hour before bedtime. The training is done to seek the regain of brain-Colon reflex and to bypass the psychic trauma of the child due to constipation with overflow which was wrongly diagnosed as incontinence. While the child was sitting in the toilet, no commands were directed to him/her. As there is no need to give a burden to his rehabilitation and to ensure that the axis is involuntarily done. Child is asked to leave the toilet even if there is no desire for defecation.
- Exercise and daily activity: Increased daily activity and frequent exercise is favored to increase bowel movement and decrease psychic distress. Regular sports by fixed timing triple a week is encouraged.
- Psychic therapy:
Family support is a golden axis for management progress, the feeling of security and backing plays an important role in fixing the problem and increase morale. Sometimes a child may need a psychiatric visit if it was a long time of constipation, and the overflow left a psychic trauma to the child.
II. The Pharmacological Colon Support That was done by trying to reduce the impacted colon load as to regain the lost or altered elasticity through the longtime of constipation and reabsorption of fluids through increased contact time between fecal matter and Intestine. The golden role that was informed to parents is that the hanged sign should be joined with drug protocol according to bowel evacuation intervals. So, another sign is drawn to parents with medication role related to bowel habits, to be easy remembered a card was designed as traffic light with Stop, Care and Go orders according to defecation modes Fig (2,3). An osmotic laxative medication (Lactulose) is thought to be a green light medication for a three-month period of program. If more than 24 hours with no defecation happened a yellow sign is hanged and a Na picosulphate drops is prescribed for the second day, if still no acceptable defecation retained, a red sign on the third day is waved and a local Enema with Mono/disodium phosphate is applied, then a green sign is regained. This regimen is maintained for three months and first follow-up with complete data on using the yellow or red sign is achieved within the first three weeks.
- Diet protocol As done with medication protocol, another traffic light card with instructions of which food can go (Green) as vegetables, Laxative fruits, and plenty of fluids. Other diet groups may be taken with caution (yellow) as Proteins, dairy products and low to medium doses of carbohydrates. While the last group (Red) should be quietly banned as conservatives contained diets, fats or constipating or citrus fruits. child is advised to take his main meals at a fixed time.
- Follow up. A Statistical sheet is delivered to parents to fulfill the numbers of bowel habits per day, how many times we had to take Picosulphate drops and/or Enemas? how many times has the child had soiled underwear? and how many times he succeeded in defecating during toilet training.
Figure 1: Rome IV disorders of chronic constipation5.
Child/Adolescent, 12
A minimum of 1 month of two or more of the following occurring at least once per week, with insufficient criteria for a diagnosis of irritable bowel:
- Two or fewer defecation in the toilet per week in a child of developmental age of at least 4 years.
- At least one episode of fecal incontinence per week.
- History of retentive posturing or excessive volitional stool retention.
- History of painful or hard bowel movements.
- Presence of a large fecal mass in the rectum.
- History of large diameter stools that can obstruct the toilet after appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
Figure 2: Traffic sign card of diet regimen.
Figure 3: Traffic sign card of drug protocol
One Bowel habit by third day at least.
Figure 4: The golden role sign.
- Conditions
- Constipation Chronic Idiopathic
- Being tested
- laxatives
- Keywords
- constipation, pediatrics, ACE, non surgical
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laxativesCombination product
triple therapy of drugs, behaviour and mental axis
| Study group | Role | What they receive |
|---|---|---|
| NEW PROTOCOL | Experimental | Using the triple therapy protocol for management of FC Receives: Combination Product: laxatives |
| CONVENTIONAL | Experimental | Using the conventional laxative therapy with rehabilitation (two axis) only Receives: Combination Product: laxatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of toilets per day
how many times the patient evacuate colon contents
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study startMar 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation Chronic IdiopathicStudies of the same condition, open and under way.
- More trials run by Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ahmed ElSayed A. Moustafa, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082622
- Sponsor's protocol ID
- minia school of medicine
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all eligible data to be shared will be available for researchers with organization domain addresses
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Triple Management Program in the Management of Functional Chronic Constipation in Children
- ClinicalTrials.gov ID
- NCT06082622
- Acronym / sponsor ID
- minia school of medicine
- Conditions
- Constipation Chronic Idiopathic
- Keywords
- constipation, pediatrics, ACE, non surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 13 Oct 2023 (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.
Abstract Background: Chronic constipation is a common disease in children, 3% all children visit gastroenterology clinics with different types and complains. It is very harsh, time consuming and psychological problems to a child and all his family members.
Objective: To find a simple and effective training method that manages the bowel habits intervals both easy and effective for both child and parents.
Patients and methods: A training program for 18 weeks in 180 children with follow up every three months for 3 years between March 2016 and April 2019. Two groups were assembled, Group (A) with 90 children managed by the 3 Role program and Group (B) formed of the other 90 children treated with traditional guidelines. All types of functional Constipations and all ages are distributed equally in the two Groups. The Parents were taught to Hang a Sign Saying (One Bowel habit by third day at least) and then follow the Triple method program for 18 weeks. First follow up is on the 3rd week. The triple axis program is working on mental, colon elasticity and fecal consistency. The Mental axis is done by bowel interval sets in fixed 3 times for 10 minutes in each, Colon contents by certain diet protocol and colon motility and elasticity by drugs.
Detailed description
- Introduction Functional constipation (FC) is a common problem in children, with an estimated worldwide incidence of 9.5% . If there is no underlying organic reason, which is the case in up to 95% of children, constipation is classified as FC. The etiology of the 5% of cases with an organic origin range from metabolic to endocrine problems to Hirschsprung disease, anorectal malformations, and neuromuscular diseases. To diagnose Constipation in a child clinically, it is currently based on the pediatric diagnostic Rome IV criteria, Figure 1. Constipation poses a significant burden on both children and their family and is associated with a reduced quality of life, diminished academic performances and psychological problems including aggression, anxiety, depression, and altered emotional reactivity. Moreover, constipation is common in children with behavioral disorders, such as attention deficit hyperactivity disorder and autism spectrum disorders . Symptoms of FC may persist into adulthood despite adequate laxative treatment. The pathophysiology of constipation is multifactorial and incompletely understood. In more than 90 % of the cases, there is no organic explanation for the symptoms. Genetic predisposition, low-socio economic status, inadequate daily fiber intake, insufficient fluid intake, and immobility have been proposed as factors leading to FC. The most encountered etiological factor in children is withholding behavior, usually occurring after experiencing a painful or frightening evacuation of stools. Rome III criteria are commonly used to define functional constipation. Children with developmental age of at least 4 years must fulfill two or more of the following criteria. They should have insufficient criteria for diagnosis of irritable bowel syndrome. The criteria must be fulfilled at least once per week for at least 2 months before diagnosis. There should be no evidence of an organic disease explaining the symptoms .
- Two or fewer defecations in the toilet per week.
- At least one episode of fecal incontinence per week.
- History of retentive posturing or excessive volitional stool retention.
- History of painful or hard bowel movements.
- Presence of a large fecal mass in the rectum.
- History of large diameter stools. Almost identical criteria have been defined for infants and toddlers. Those criteria should be fulfilled for at least 1 month .
- Treatment regimens Conventional treatment of children with Functional Constipation involves non-pharmacological interventions (education, toilet training, defecation diary, and reward system) in combination with pharmacological interventions such as oral laxatives, of which poly-ethylene glycol is the first-line drug of choice.
Alternative treatment options for children with intractable constipation are limited and include anal sphincter botulinum toxin injections, trans anal irrigation, antegrade continent enemas (ACE), and, in rare cases, sacral nerve stimulation (SNS) and partial or total surgical resection of the colon15. and is frequently associated with fecal incontinence. In pediatrics, fecal incontinence has been defined as the voluntary or involuntary passage of feces into the underwear or in socially inappropriate places, in a child with a developmental age of at least 4 years. It has been suggested that in otherwise healthy children, fecal incontinence is secondary to 'overflow', and therefore results from the presence of constipation . This review aims to find a simple and effective training method that manages the bowel habits intervals both easy and effective for both child and parents. The exact prevalence of functional fecal incontinence associated with stool retention varies.
- Methodology A training program for 18 weeks in 180 children with follow up every three months for 3 years between March 2016 and April 2019. Two groups were assembled, Group (A) formed of the other 90 children treated with the 3 role program and Group (B) with 90 children managed by the previously mentioned traditional guidelines. All types of Constipations and all ages are distributed equally in the two Groups. The Parents in Group A were thought to Hang a Sign of (One Bowel habit by third day at least) and then follow the triple method program for 3 months. First follow up is on the 3rd week. The triple axis program is working on Psychic and mental axis, colon to retain its elasticity and fecal consistency.
- The Mental axis (Gut-Brain interaction)
- Habit timing training: It is done by bowel interval sets in fixed 3 times for 10-15 minutes of each, the preferred timing for training is just after breakfast, lunch and one hour before bedtime. The training is done to seek the regain of brain-Colon reflex and to bypass the psychic trauma of the child due to constipation with overflow which was wrongly diagnosed as incontinence. While the child was sitting in the toilet, no commands were directed to him/her. As there is no need to give a burden to his rehabilitation and to ensure that the axis is involuntarily done. Child is asked to leave the toilet even if there is no desire for defecation.
- Exercise and daily activity: Increased daily activity and frequent exercise is favored to increase bowel movement and decrease psychic distress. Regular sports by fixed timing triple a week is encouraged.
- Psychic therapy:
Family support is a golden axis for management progress, the feeling of security and backing plays an important role in fixing the problem and increase morale. Sometimes a child may need a psychiatric visit if it was a long time of constipation, and the overflow left a psychic trauma to the child.
II. The Pharmacological Colon Support That was done by trying to reduce the impacted colon load as to regain the lost or altered elasticity through the longtime of constipation and reabsorption of fluids through increased contact time between fecal matter and Intestine. The golden role that was informed to parents is that the hanged sign should be joined with drug protocol according to bowel evacuation intervals. So, another sign is drawn to parents with medication role related to bowel habits, to be easy remembered a card was designed as traffic light with Stop, Care and Go orders according to defecation modes Fig (2,3). An osmotic laxative medication (Lactulose) is thought to be a green light medication for a three-month period of program. If more than 24 hours with no defecation happened a yellow sign is hanged and a Na picosulphate drops is prescribed for the second day, if still no acceptable defecation retained, a red sign on the third day is waved and a local Enema with Mono/disodium phosphate is applied, then a green sign is regained. This regimen is maintained for three months and first follow-up with complete data on using the yellow or red sign is achieved within the first three weeks.
- Diet protocol As done with medication protocol, another traffic light card with instructions of which food can go (Green) as vegetables, Laxative fruits, and plenty of fluids. Other diet groups may be taken with caution (yellow) as Proteins, dairy products and low to medium doses of carbohydrates. While the last group (Red) should be quietly banned as conservatives contained diets, fats or constipating or citrus fruits. child is advised to take his main meals at a fixed time.
- Follow up. A Statistical sheet is delivered to parents to fulfill the numbers of bowel habits per day, how many times we had to take Picosulphate drops and/or Enemas? how many times has the child had soiled underwear? and how many times he succeeded in defecating during toilet training.
Figure 1: Rome IV disorders of chronic constipation5.
Child/Adolescent, 12
A minimum of 1 month of two or more of the following occurring at least once per week, with insufficient criteria for a diagnosis of irritable bowel:
- Two or fewer defecation in the toilet per week in a child of developmental age of at least 4 years.
- At least one episode of fecal incontinence per week.
- History of retentive posturing or excessive volitional stool retention.
- History of painful or hard bowel movements.
- Presence of a large fecal mass in the rectum.
- History of large diameter stools that can obstruct the toilet after appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
Figure 2: Traffic sign card of diet regimen.
Figure 3: Traffic sign card of drug protocol
One Bowel habit by third day at least.
Figure 4: The golden role sign.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEW PROTOCOL | Experimental | Combination Product: laxativesUsing the triple therapy protocol for management of FC |
| CONVENTIONAL | Experimental | Combination Product: laxativesUsing the conventional laxative therapy with rehabilitation (two axis) only |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All types of Constipations and all ages are distributed equally in the two Groups
Key exclusion criteria (1 listed)
- surgically treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laxativestriple therapy of drugs, behaviour and mental axis | Combination product | CONVENTIONAL, NEW PROTOCOL |
Primary outcome
number of toilets per day
Time frame: 3 days
how many times the patient evacuate colon contents
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Yes. all eligible data to be shared will be available for researchers with organization domain addresses
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laxatives in people with Constipation Chronic Idiopathic, run by Minia University.
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 1 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: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of toilets per day (time frame: 3 days). 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 13 Oct 2023.