Effect of FAn-7 in UC Activity (FAUC)

January 16, 2013 updated by: Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Tlalpan
      • DF, Tlalpan, Mexico, 14000
        • Recruiting
        • INCMNSZ
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesus K Yamamoto, MD, PhD
        • Sub-Investigator:
          • Nallely Bueno, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: palmitoleic acid
Palmitoleic acid: 720 mg/day for 56 days
Dietary supplement: Palmitoleic acid
Palmitoleic acid and 5-ASA
PLACEBO_COMPARATOR: Sugar pill
Sugar pill: 720 mg/day for 56 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

  • Study Director: Jesús K Yamamoto, MD, PhD, Inflammatory Bowel Disease Clinic
  • Principal Investigator: Nallely Bueno, MSc, Inflammatory Bowel Disease Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (ESTIMATE)

January 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REF453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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