Anal Fissures Treatment and Oligoantigenic DietNCT01637857
Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures.
A study testing oligoantigenic diet in people with Anal Fissures Treatment and Oligoantigenic Diet, run by University of Palermo at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Anal Fissures Treatment and Oligoantigenic Diet
- What is being tested?
- oligoantigenic diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- evidence of chronic anal fissures evaluated by an experienced rectal surgeon
- patient age >16 years.
Who cannot join
- a diagnosis of inflammatory bowel disease
- ongoing steroid treatment performed for any reason
- an exclusion diet followed for any reason
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Surgery Department, University of Palermo, Italy
Palermo, Italy, 90127
About this study
Official title: Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures. Evidence for a Relationship Between Food Hypersensitivity and Anal Fissures
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.
Read the 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.
- Being tested
- sham oligoantigenic diet associated to lifestyle instruction, oligoantigenic diet
- Keywords
- foof hypersensitivity, anal fissures, ano-rectal manometry
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham oligoantigenic diet associated to lifestyle instructionDietary supplement
sham oligoantigenic diet associated to lifestyle instruction
oligoantigenic dietDietary supplement
oligoantigenic diet associated to life style counseling
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | Sham comparator | Group of patients treated with sham oligoantigenic diet Receives: Dietary Supplement: sham oligoantigenic diet associated to lifestyle instruction |
| oligoantigenic diet | Experimental | Treatment with oligoantigenic diat Receives: Dietary Supplement: oligoantigenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJan 2006
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Fissures Treatment and Oligoantigenic DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Mansueto, University of Palermo
- Investigators
- Antonio Carroccio, Prof., Study director, Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, ItalyPasquale Mansueto, Dr., Principal investigator, University of PalermoSebastiano Bonventre, Dr., Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637857
- Sponsor's protocol ID
- ACPM01
- Status last verified
- Jan 2013
- First submitted
- 8 Jul 2012
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oligo-antigenic Diet in the Treatment of Chronic Anal Fissures. Evidence for a Relationship Between Food Hypersensitivity and Anal Fissures
- ClinicalTrials.gov ID
- NCT01637857
- Acronym / sponsor ID
- ACPM01
- Keywords
- foof hypersensitivity, anal fissures, ano-rectal manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | Sham comparator | Dietary Supplement: sham oligoantigenic diet associated to lifestyle instructionGroup of patients treated with sham oligoantigenic diet |
| oligoantigenic diet | Experimental | Dietary Supplement: oligoantigenic dietTreatment with oligoantigenic diat |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- evidence of chronic anal fissures evaluated by an experienced rectal surgeon
- patient age >16 years.
Key exclusion criteria (4 listed)
- a diagnosis of inflammatory bowel disease
- ongoing steroid treatment performed for any reason
- an exclusion diet followed for any reason
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham oligoantigenic diet associated to lifestyle instructionsham oligoantigenic diet associated to lifestyle instruction | Dietary supplement | lifestyle counseling |
| oligoantigenic dietoligoantigenic diet associated to life style counseling | Dietary supplement | oligoantigenic diet |
Primary outcome
Chronic anal fissures persistence or healing
Time frame: 2 years
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.
1 secondary outcome
Anal fissures recurring after Double-Blind Placebo-Controlled food challenge
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Carroccio, Prof. study director
Internal Medicine, Hospital of Sciacca, ASP Agrigento, University of Palermo, Italy
Pasquale Mansueto, Dr. principal investigator
University of Palermo
Sebastiano Bonventre, Dr. principal investigator
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oligoantigenic diet in people with Anal Fissures Treatment and Oligoantigenic Diet, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic anal fissures persistence or healing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.