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

NCT01637857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2013-01-11

No results posted yet for this study

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.

Conditions

  • Anal Fissures Treatment and Oligoantigenic Diet

Interventions

DIETARY_SUPPLEMENT

sham oligoantigenic diet associated to lifestyle instruction

sham oligoantigenic diet associated to lifestyle instruction

DIETARY_SUPPLEMENT

oligoantigenic diet

oligoantigenic diet associated to life style counseling

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Antonio Carroccio, Prof. · Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, Italy

  • Pasquale Mansueto, Dr. · University of Palermo

  • Sebastiano Bonventre, Dr. · University of Palermo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637857 on ClinicalTrials.gov