Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Palmitoleic acid ulcerative colitis
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.
Interventions
DIETARY_SUPPLEMENTPalmitoleic acid
Palmitoleic acid and 5-ASA
Sponsors
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical and endoscopic remission | 2 months | We will perfom a basal and final colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quantification IL-6 in colonic mucosa | 2 months | quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention. |
Countries
Mexico
Contacts
Primary ContactJesus K Yamamoto, MD, PhD
Backup ContactNallely Bueno, MSc
Outcome results
None listed