Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06082622 |
| Other study ID # |
minia school of medicine |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
April 2019 |
Study information
| Verified date |
October 2023 |
| Source |
Minia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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 .
1. Two or fewer defecations in the toilet per week.
2. At least one episode of fecal incontinence per week.
3. History of retentive posturing or excessive volitional 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. 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.
I. The Mental axis (Gut-Brain interaction)
1. 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.
2. 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.
3. 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.
