NCT07392203

Brief Summary

Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
4mo left

Started Feb 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 12, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 12, 2026

Last Update Submit

February 2, 2026

Conditions

Anorectal Malformation

Outcome Measures

Primary Outcomes (2)

  • Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.

    Follow up after 4 weeks and after 12 weeks

  • Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.

    4 weeks

Study Arms (1)

Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri

EXPERIMENTAL

Prospective, single-arm, single-centre interventional study conducted in the Pediatric Surgery Department, Sohag University Hospitals. The protocol adheres to contemporary bowel-management frameworks for pediatric fecal incontinence with daily retrograde enemas and radiographic/clinical titration.

Procedure: Rectal enema using saline and glycerin mixture once daily

Interventions

Rectal enema using saline and glycerin mixture once dailyPROCEDURE

Rectal enema using saline \& glycerin for treatment of fecal incontinence in children

Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

Location

MeSH Terms

Conditions

Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Suzan Ali Mohammed, Resident of pediatric surgery

CONTACT

01143847284an4562195@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of pediatric surgery

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 6, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

EG(1)