Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-01 @ 6:28 PM
Study NCT ID:
NCT01582659
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Treatment of Constipation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment recovery', 'timeFrame': '1 year', 'description': 'Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.'}], 'secondaryOutcomes': [{'measure': 'Usage of laxative.', 'timeFrame': '1 year', 'description': 'Amount of laxative used during the study periode.'}, {'measure': 'Telephone contacts', 'timeFrame': '1 year', 'description': 'Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['constipation', 'children', 'outpatient'], 'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '26348685', 'type': 'DERIVED', 'citation': 'Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.'}]}, 'descriptionModule': {'briefSummary': 'Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a pediatric ward for specialized treatment.\n\nThere is currently little research on the subject and treatment is therefore based on expert knowledge rather than scientific research.\n\nThe study objective is to identify the most effective and least stressful treatment of children with constipation for both families and the health care system.\n\nThe following will be tested:\n\nDoes treatment of constipation in children require specialized knowledge and extensive resources or can the treatment be simplified?\n\nThe results from this study are expected to form the basis for a evidence based treatment of children with constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.\n* Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.\n\nExclusion Criteria:\n\n* Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.\n* Children receiving drugs known to affect bowel function during a 2 month period before initiation.'}, 'identificationModule': {'nctId': 'NCT01582659', 'briefTitle': 'Outpatient Treatment of Constipation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'Outpatient Treatment of Constipation in Children - a Randomized Interventions Study', 'orgStudyIdInfo': {'id': 'OutCon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No ekstra counseling', 'description': 'Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 counseling sessions', 'description': 'Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.', 'interventionNames': ['Other: Telephone counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Web access', 'description': 'Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made but the family are given access to a website with information about childhood constipation.', 'interventionNames': ['Other: Web access']}], 'interventions': [{'name': 'Telephone counseling', 'type': 'OTHER', 'otherNames': ['Telephone'], 'description': '2 planned telephone counseling sessions are conducted.', 'armGroupLabels': ['2 counseling sessions']}, {'name': 'Web access', 'type': 'OTHER', 'otherNames': ['Web'], 'description': 'Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.', 'armGroupLabels': ['Web access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Line Modin', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Pediatric department, Kolding Hospital', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}], 'overallOfficials': [{'name': 'Marianne Jakobsen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kolding'}, {'name': 'Poul Erik Kofoed, MD. PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kolding'}, {'name': 'Line Modin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kolding'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Line Modin', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Line Modin', 'investigatorAffiliation': 'Vejle Hospital'}}}}