Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.
1 other identifier
interventional
161
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 8, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedJanuary 11, 2013
January 1, 2013
3.9 years
July 8, 2012
January 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic anal fissures persistence or healing
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.
2 years
Secondary Outcomes (1)
Anal fissures recurring after Double-Blind Placebo-Controlled food challenge
2 years
Study Arms (2)
lifestyle counseling
SHAM COMPARATORGroup of patients treated with sham oligoantigenic diet
oligoantigenic diet
EXPERIMENTALTreatment with oligoantigenic diat
Interventions
sham oligoantigenic diet associated to lifestyle instruction
oligoantigenic diet associated to life style counseling
Eligibility Criteria
You may qualify if:
- evidence of chronic anal fissures evaluated by an experienced rectal surgeon
- patient age \>16 years.
You may not qualify if:
- a diagnosis of inflammatory bowel disease
- ongoing steroid treatment performed for any reason
- pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Surgery Department, University of Palermo, Italy
Palermo, Italy, 90127, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonio Carroccio, Prof.
Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, Italy
- PRINCIPAL INVESTIGATOR
Pasquale Mansueto, Dr.
University of Palermo
- PRINCIPAL INVESTIGATOR
Sebastiano Bonventre, Dr.
University of Palermo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 8, 2012
First Posted
July 11, 2012
Study Start
January 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
January 11, 2013
Record last verified: 2013-01