Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-28 @ 11:59 AM
Study NCT ID:
NCT01637857
Status:
COMPLETED
Last Update Posted:
2013-01-11
First Post:
2012-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}], 'ancestors': [{'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-10', 'studyFirstSubmitDate': '2012-07-08', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic anal fissures persistence or healing', 'timeFrame': '2 years', 'description': 'The patients will be evaluated every two weeks for eight weeks for CAF persistence or healing; anal pain will be scored on a visual analogue scale ranging from 0 (absence of pain) to 10 (intolerable pain). Anal-rectal manometry will be repeated at the end of the study period, in all patients who will be treated.'}], 'secondaryOutcomes': [{'measure': 'Anal fissures recurring after Double-Blind Placebo-Controlled food challenge', 'timeFrame': '2 years', 'description': 'In this part of the study will be included patients with healed chronic anal fissures on true elimination diet (GROUP B) plus patients of GROUP A, who received "sham elimination diet", uncured, were offered the treatment option of "true elimination diet" before undergoing surgery, accepted, and finally cured. Therefore, we will evaluate anal fissures recurring after Double-Blind Placebo-Controlled Food Challenges with cow\'s milk and wheat, and Open Challenges with other foods (i.e. egg, tomato and chocolate).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['foof hypersensitivity', 'anal fissures', 'ano-rectal manometry'], 'conditions': ['Anal Fissures Treatment and Oligoantigenic Diet']}, 'descriptionModule': {'briefSummary': "Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AF). We aim to evaluate the effectiveness of a diet in curing AF and the clinical effects of a double-blind placebo controlled (DBPC) challenge with cow's milk protein or wheat.", 'detailedDescription': 'Context: Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AF).\n\nObjective: We aim to evaluate 1) the effectiveness of a diet in curing AF; 2) the clinical effects of a double-blind placebo controlled (DBPC) challenge with cow\'s milk protein or wheat.\n\nDesign: The study will have two different parts: the first to verify the effectiveness of the oligo-antigenic diet in chronic AF treatment; the second to search for a possible cause-effect relationship between the diet and the onset of the AF.\n\nSetting: We will enrol consecutive adult patients with chronic AF who will refer to a Surgical Department of the University of Palermo for a 3-years period. Inclusion criteria are: evidence of CAF evaluated by an experienced rectal surgeon; patient age \\>16 years. Exclusion criteria are: a diagnosis of inflammatory bowel disease, ongoing steroid treatment performed for any reason, an exclusion diet followed for any reason, and pregnancy. At the time of the first evaluation, routine laboratory tests, immunology tests, rectal biopsies and anal-rectal manometry will be performed.\n\nPatients: patients, finally included in the study, will be randomized to one of the treatment groups.\n\nInterventions: Enrolled patients will be randomized to receive a "true elimination diet" or a "sham elimination diet"; both groups will also receive topical nifedipine and lidocaine.\n\nMain Outcome Measures: The patients will be evaluated every two weeks for CAF persistence or healing; anal pain will be scored on a visual analogue scale ranging from 0 (absence of pain) to 10 (intolerable pain). Anal-rectal manometry will be repeated at the end of the study period, in all patients who will be treated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* evidence of chronic anal fissures evaluated by an experienced rectal surgeon\n* patient age \\>16 years.\n\nExclusion Criteria:\n\n* a diagnosis of inflammatory bowel disease\n* ongoing steroid treatment performed for any reason\n* an exclusion diet followed for any reason\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT01637857', 'briefTitle': 'Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures. Evidence for a Relationship Between Food Hypersensitivity and Anal Fissures', 'orgStudyIdInfo': {'id': 'ACPM01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'lifestyle counseling', 'description': 'Group of patients treated with sham oligoantigenic diet', 'interventionNames': ['Dietary Supplement: sham oligoantigenic diet associated to lifestyle instruction']}, {'type': 'EXPERIMENTAL', 'label': 'oligoantigenic diet', 'description': 'Treatment with oligoantigenic diat', 'interventionNames': ['Dietary Supplement: oligoantigenic diet']}], 'interventions': [{'name': 'sham oligoantigenic diet associated to lifestyle instruction', 'type': 'DIETARY_SUPPLEMENT', 'description': 'sham oligoantigenic diet associated to lifestyle instruction', 'armGroupLabels': ['lifestyle counseling']}, {'name': 'oligoantigenic diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oligoantigenic diet associated to life style counseling', 'armGroupLabels': ['oligoantigenic diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90127', 'city': 'Palermo', 'state': 'Italy', 'country': 'Italy', 'facility': 'Surgery Department, University of Palermo, Italy', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'overallOfficials': [{'name': 'Antonio Carroccio, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, Italy'}, {'name': 'Pasquale Mansueto, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Palermo'}, {'name': 'Sebastiano Bonventre, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Palermo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Pasquale Mansueto', 'investigatorAffiliation': 'University of Palermo'}}}}