Effect of FAn-7 in UC Activity

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4γ and Ulcerative Colitis (UC) Activity

Conditions
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Inflammatory Bowel Disease, Ulcerative Colitis

Intervention / Treatment
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* Dietary Supplement: Palmitoleic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: palmitoleic acid<br>Palmitoleic acid: 720 mg/day for 56 days | Dietary Supplement: Palmitoleic acid<br>* Palmitoleic acid and 5-ASA<br>|
| Placebo Comparator: Sugar pill<br>Sugar pill: 720 mg/day for 56 days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and endoscopic remission | We will perfom a basal and final colonoscopy | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantification IL-6 in colonic mucosa | quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palmitoleic acid ulcerative colitis