Clinical trial NCT01771224: Effect of FAn-7 in UC Activity
Official title: Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4γ and Ulcerative Colitis (UC) Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Keywords: Palmitoleic acid ulcerative colitis
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: clinical and endoscopic remission
timeFrame: 2 months
Secondary outcomes:
measure: quantification IL-6 in colonic mucosa
timeFrame: 2 months
Other outcomes:
Locations:
city: DF
country: Mexico
facility: INCMNSZ
state: Tlalpan
Study officials:
affiliation: Inflammatory Bowel Disease Clinic
name: Jesús K Yamamoto, MD, PhD
role: STUDY_DIRECTOR
affiliation: Inflammatory Bowel Disease Clinic
name: Nallely Bueno, MSc
role: PRINCIPAL_INVESTIGATOR
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