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

NCT06082622 | Completed DMC

• 1 other identifier: minia school of medicine
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Constipation Chronic Idiopathic

Keywords

constipation; pediatrics; ACE; non surgical

Outcome Measures

Primary Outcomes (1)

• number of toilets per day

  how many times the patient evacuate colon contents

  3 days

Study Arms (2)

NEW PROTOCOL

EXPERIMENTAL

Using the triple therapy protocol for management of FC

Combination Product: laxatives

CONVENTIONAL

EXPERIMENTAL

Using the conventional laxative therapy with rehabilitation (two axis) only

Combination Product: laxatives

Interventions

laxatives COMBINATION_PRODUCT

triple therapy of drugs, behaviour and mental axis

CONVENTIONAL; NEW PROTOCOL

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All types of Constipations and all ages are distributed equally in the two Groups

You may not qualify if:

• surgically treated

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Constipation

Interventions

Laxatives

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pediatric surgery

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 13, 2023
• Study Start: March 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after manuscript is accepted to be published and it will be affordable for as long as it required
• Access Criteria: by e-mail