Clinical trial

Evaluation of the Triple Management Program in the Management of Functional Chronic Constipation in Children

Name
minia school of medicine
Description
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.
Trial arms
Trial start
2016-03-01
Estimated PCD
2019-04-01
Trial end
2019-04-01
Status
Completed
Treatment
laxatives
triple therapy of drugs, behaviour and mental axis
Arms:
CONVENTIONAL, NEW PROTOCOL
Size
180
Primary endpoint
number of toilets per day
3 days
Eligibility criteria
Inclusion Criteria: * All types of Constipations and all ages are distributed equally in the two Groups Exclusion Criteria: * surgically treated
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2023-10-13

1 organization

1 product

1 indication

Organization
Minia University
Product
laxatives