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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo
ClinicalTrials.gov Identifier:
NCT01637857
First received: July 8, 2012
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Anal Fissures Treatment and Oligoantigenic Diet
Dietary Supplement: sham oligoantigenic diet associated to lifestyle instruction
Dietary Supplement: oligoantigenic diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures. Evidence for a Relationship Between Food Hypersensitivity and Anal Fissures

Resource links provided by NLM:


Further study details as provided by University of Palermo:

Primary Outcome Measures:
  • Chronic anal fissures persistence or healing [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Anal fissures recurring after Double-Blind Placebo-Controlled food challenge [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Enrollment: 161
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: lifestyle counseling
Group of patients treated with sham oligoantigenic diet
Dietary Supplement: sham oligoantigenic diet associated to lifestyle instruction
sham oligoantigenic diet associated to lifestyle instruction
Experimental: oligoantigenic diet
Treatment with oligoantigenic diat
Dietary Supplement: oligoantigenic diet
oligoantigenic diet associated to life style counseling

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637857

Locations
Italy
Surgery Department, University of Palermo, Italy
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
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
  More Information

No publications provided

Responsible Party: Pasquale Mansueto, MD, University of Palermo
ClinicalTrials.gov Identifier: NCT01637857     History of Changes
Other Study ID Numbers: ACPM01
Study First Received: July 8, 2012
Last Updated: January 10, 2013
Health Authority: Italy: Ministry of Education, University and Research

Keywords provided by University of Palermo:
foof hypersensitivity
anal fissures
ano-rectal manometry

Additional relevant MeSH terms:
Fissure in Ano
Hypersensitivity
Anus Diseases
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014