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

NCT ID: NCT01637857

Last Updated: 2013-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-12-31

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.

Detailed 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.

Conditions

Anal Fissures Treatment and Oligoantigenic Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lifestyle counseling

Group of patients treated with sham oligoantigenic diet

Group Type: SHAM_COMPARATOR

sham oligoantigenic diet associated to lifestyle instruction

Intervention Type: DIETARY_SUPPLEMENT

sham oligoantigenic diet associated to lifestyle instruction

oligoantigenic diet

Treatment with oligoantigenic diat

Group Type: EXPERIMENTAL

oligoantigenic diet

Intervention Type: DIETARY_SUPPLEMENT

oligoantigenic diet associated to life style counseling

Interventions

sham oligoantigenic diet associated to lifestyle instruction

sham oligoantigenic diet associated to lifestyle instruction

Intervention Type: DIETARY_SUPPLEMENT

oligoantigenic diet

oligoantigenic diet associated to life style counseling

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Pasquale Mansueto

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Carroccio, Prof.

Role: STUDY_DIRECTOR

Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, Italy

Pasquale Mansueto, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Sebastiano Bonventre, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Locations

Surgery Department, University of Palermo, Italy

Palermo, Italy, Italy

Countries

Italy

Other Identifiers

ACPM01

Identifier Type: -

Identifier Source: org_study_id