Anorectal MalformationEarly Phase 1NCT07392203
Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children
A Early Phase 1 study testing Rectal enema using saline and glycerin mixture once daily in people with Anorectal Malformation, run by Sohag University at 1 site in Egypt.
Trial summary
Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Anorectal Malformation
- What is being tested?
- Rectal enema using saline and glycerin mixture once daily
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2026to 30 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.
Read the detailed description
Child lies on Lt lateral position. Foley catheter inserted to thr rectum and inflated Instillation of saline glycerin mixture. Child hold it for 15 minutes Foley catheter removed Child stay in bathroom for 45 min
- Conditions
- Anorectal Malformation
- Being tested
- Rectal enema using saline and glycerin mixture once daily
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal enema using saline and glycerin mixture once dailyProcedure or surgery
Rectal enema using saline \& glycerin for treatment of fecal incontinence in children
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Rectal enema using saline and glycerin mixture once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal MalformationStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souzan ALi Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392203
- Sponsor's protocol ID
- Soh-Med-25-12-13MS
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children
- ClinicalTrials.gov ID
- NCT07392203
- Acronym / sponsor ID
- Soh-Med-25-12-13MS
- Conditions
- Anorectal Malformation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.
Detailed description
Child lies on Lt lateral position. Foley catheter inserted to thr rectum and inflated Instillation of saline glycerin mixture. Child hold it for 15 minutes Foley catheter removed Child stay in bathroom for 45 min
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri | Experimental | Procedure: Rectal enema using saline and glycerin mixture once dailyProspective, 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. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Rectal enema using saline and glycerin mixture once dailyRectal enema using saline \& glycerin for treatment of fecal incontinence in children | Procedure or surgery | Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri |
Primary outcome
Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.
Time frame: 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.
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rectal enema using saline and glycerin mixture once daily in people with Anorectal Malformation, run by Sohag University at 1 site in Egypt.
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 0 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzan Ali Mohammed, Resident of pediatric surgery (01143847284, an4562195@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4. (time frame: Follow up after 4 weeks and after 12 weeks). The study lists 2 primary outcomes in all. 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 6 Feb 2026.