Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.

Anal Fissures Treatment and Oligoantigenic Diet Clinical Trial

Official title:

Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures. Evidence for a Relationship Between Food Hypersensitivity and Anal Fissures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637857
• Other study ID #: ACPM01
• Status: Completed
• Phase: N/A
• First received: July 8, 2012
• Last updated: January 10, 2013
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Education, University and Research
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Objective: 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.

Design: 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.

Setting: 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.

Patients: patients, finally included in the study, will be randomized to one of the treatment groups.

Interventions: 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.

Main 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• evidence of chronic anal fissures evaluated by an experienced rectal surgeon

• patient age >16 years.

Exclusion Criteria:

• a diagnosis of inflammatory bowel disease

• ongoing steroid treatment performed for any reason

• an exclusion diet followed for any reason

• pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fissures Treatment and Oligoantigenic Diet
• Fissure in Ano
• Hypersensitivity

Intervention

Dietary Supplement:
• sham oligoantigenic diet associated to lifestyle instruction
sham oligoantigenic diet associated to lifestyle instruction
• oligoantigenic diet
oligoantigenic diet associated to life style counseling

Locations

Country	Name	City	State
Italy	Surgery Department, University of Palermo, Italy	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Anal fissures recurring after Double-Blind Placebo-Controlled food challenge	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).	2 years	No