Effect of FAn-7 in UC Activity

Early Phase 1UnknownNCT01771224

National Institute of Medical Sciences and Nutrition, Salvador Zubiran20 enrolled

Overview

Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional treatment is not effective; therefore, alternative therapies may be effective specially in UC patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The increasing incidence and prevalence of UC and ineffective treatments in some patients, allows search coadjuvant therapies. Objective: Quantification of differences between patients with and without FA. Methods: In two groups of patients with UC is administered FA and placebo. We will measure the changes clinical, endoscopic and histological in both groups, before and after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inflammatory Bowel Disease Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a histopathologically confirmed diagnosis of UC. * With mild and moderate disease. * Patients treated with only doses of 5-aminosalicylates (5-ASA) * BMI, 18 to 34.9 kg/m2 * Born in Mexico the last two generations * Each patient will be asked to sign and date the consent form, to indicate that you agree to participate. Exclusion Criteria: * Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome. * With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease. * If the patient use drugs that inhibit fat absorption. * Patients after partial or total resection of stomach or small intestine. * Steroid users. * Patients in remission histology, clinical and endoscopic. * Patients treated with FAn-3,6 or 9.

Outcomes

Primary Outcomes

clinical and endoscopic remission

We will perfom a basal and final colonoscopy

Time frame: 2 months

Secondary Outcomes

quantification IL-6 in colonic mucosa

quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention.

Time frame: 2 months

Central Contacts

Jesus K Yamamoto, MD, PhD

CONTACT

54870900 kazuofurusho@hotmail.com

Nallely Bueno, MSc