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Effect of FAn-7 in UC Activity (FAUC)

This study is currently recruiting participants.
Verified January 2012 by National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor:
Information provided by (Responsible Party):
Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01771224
First received: January 16, 2013
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Ulcerative Colitis
 Dietary Supplement: Palmitoleic acid
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4γ and Ulcerative Colitis (UC) Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:

Primary Outcome Measures:
  • clinical and endoscopic remission [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    We will perfom a basal and final colonoscopy


Secondary Outcome Measures:
  • quantification IL-6 in colonic mucosa [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention.


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771224

Contacts
Contact: Jesus K Yamamoto, MD, PhD 54870900 ext 2710 kazuofurusho@hotmail.com
Contact: Nallely Bueno, MSc 54870900 ext 2712 nallely_bh5@yahoo.com.mx

Locations
Mexico
INCMNSZ Recruiting
DF, Tlalpan, Mexico, 14000
Contact: Jesus K Furusho, MD, PhD     +5554870900 ext 2710     kazuofurusho@hotmail.com    
Contact: Nallely Bueno, MSc     +5554870900 ext 2712     nallely_bh5@yahoo.com.mx    
Principal Investigator: Jesus K Yamamoto, MD, PhD            
Sub-Investigator: Nallely Bueno, MSc            
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Jesús Kazuo Yamamoto Furusho, MD PhD, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01771224     History of Changes
Other Study ID Numbers: REF453
Study First Received: January 16, 2013
Last Updated: January 16, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
Palmitoleic acid ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013