Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 3:48 AM
Study NCT ID:
NCT07392203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071056', 'term': 'Anorectal Malformations'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.', 'timeFrame': 'Follow up after 4 weeks and after 12 weeks'}, {'measure': 'Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anorectal Malformation']}, 'descriptionModule': {'briefSummary': 'Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'InclusioChildren ≥3 and ≤16 years with Fecal incontinence (≥1 episode/week) due to corrected anorectal malformation (ARM), Hirschsprung disease after pull-through, perineal trauma, spinal anomalies/neurogenic bowel, or functional constipation with overflow incontinence.\n\nAbility to participate in a structured bowel-management regimen at home.\n\nCaregiver availability for training and daily administration. n Criteria:\n\n\\- Age \\<3 years. symptomatic anal stricture, or other anatomic issues requiring surgical correction before bowel management.\n\nCurrent enterocolitis, Active proctitis, painful fissure with bleeding, or severe perianal dermatitis precluding safe catheterization.\n\nChronic kidney disease, unstable cardiac disease, or known electrolyte imbalance.\n\nHypersensitivity/intolerance to glycerin; prior severe reaction to enemas. Stoma in situ or ACE dependence (separate pathway).\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07392203', 'briefTitle': 'Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children', 'orgStudyIdInfo': {'id': 'Soh-Med-25-12-13MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri', 'description': '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.', 'interventionNames': ['Procedure: Rectal enema using saline and glycerin mixture once daily']}], 'interventions': [{'name': 'Rectal enema using saline and glycerin mixture once daily', 'type': 'PROCEDURE', 'description': 'Rectal enema using saline \\& glycerin for treatment of fecal incontinence in children', 'armGroupLabels': ['Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Suzan Ali Mohammed, Resident of pediatric surgery', 'role': 'CONTACT', 'email': 'an4562195@gmail.com', 'phone': '01143847284'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of pediatric surgery', 'investigatorFullName': 'Souzan ALi Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}