Clinical trial NCT01637857: Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.
Official title: Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures. Evidence for a Relationship Between Food Hypersensitivity and Anal Fissures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fissures Treatment and Oligoantigenic Diet
Keywords: foof hypersensitivity
anal fissures
ano-rectal manometry
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 161
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Chronic anal fissures persistence or healing
timeFrame: 2 years
Secondary outcomes:
measure: Anal fissures recurring after Double-Blind Placebo-Controlled food challenge
timeFrame: 2 years
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Surgery Department, University of Palermo, Italy
Study officials:
affiliation: Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, Italy
name: Antonio Carroccio, Prof.
role: STUDY_DIRECTOR
affiliation: University of Palermo
name: Pasquale Mansueto, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Palermo
name: Sebastiano Bonventre, Dr.
role: PRINCIPAL_INVESTIGATOR
References: