Effect of FAn-7 in UC Activity

Ulcerative Colitis Clinical Trial

— FAUC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01771224
• Other study ID #: REF453
• Status: Recruiting
• Phase: Phase 0
• First received: January 16, 2013
• Last updated: January 16, 2013
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2012
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: Jesus K Yamamoto, MD, PhD
• Phone: 54870900
• Email: kazuofurusho[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Palmitoleic acid
Palmitoleic acid and 5-ASA

Locations

Country	Name	City	State
Mexico	INCMNSZ	DF	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (13)

Ahn SH, Shah YM, Inoue J, Morimura K, Kim I, Yim S, Lambert G, Kurotani R, Nagashima K, Gonzalez FJ, Inoue Y. Hepatocyte nuclear factor 4alpha in the intestinal epithelial cells protects against inflammatory bowel disease. Inflamm Bowel Dis. 2008 Jul;14(7 — View Citation

Bueno-Hernández N, Sánchez-Muñoz F, Barreto-Zuñiga R, Dominguez-López A, Yamamoto-Furusho JK. Expression of HNF4? is downregulated in patients with active ulcerative colitis (UC) compared to UC patients in remission and healthy controls. Inflamm Bowel Dis — View Citation

Daigo K, Kawamura T, Ohta Y, Ohashi R, Katayose S, Tanaka T, Aburatani H, Naito M, Kodama T, Ihara S, Hamakubo T. Proteomic analysis of native hepatocyte nuclear factor-4a (HNF4a) isoforms, phosphorylation status, and interactive cofactors. J Biol Chem. 2 — View Citation

Drewes T, Senkel S, Holewa B, Ryffel GU. Human hepatocyte nuclear factor 4 isoforms are encoded by distinct and differentially expressed genes. Mol Cell Biol. 1996 Mar;16(3):925-31. — View Citation

Gruber L, Lichti P, Rath E, Haller D. Nutrigenomics and nutrigenetics in inflammatory bowel diseases. J Clin Gastroenterol. 2012 Oct;46(9):735-47. doi: 10.1097/MCG.0b013e31825ca21a. Review. — View Citation

Nieto N, Torres MI, Ríos A, Gil A. Dietary polyunsaturated fatty acids improve histological and biochemical alterations in rats with experimental ulcerative colitis. J Nutr. 2002 Jan;132(1):11-9. — View Citation

Nishida T, Miwa H, Shigematsu A, Yamamoto M, Iida M, Fujishima M. Increased arachidonic acid composition of phospholipids in colonic mucosa from patients with active ulcerative colitis. Gut. 1987 Aug;28(8):1002-7. — View Citation

Okuma Y, Shirao T, Sakamoto A. [Constipation in intracranial diseases--correlation betweeen the cerebrospinal fluid pressure and constipation]. Saishin Igaku. 1971 Jan;26(1):139-44. Japanese. — View Citation

Taraviras S, Mantamadiotis T, Dong-Si T, Mincheva A, Lichter P, Drewes T, Ryffel GU, Monaghan AP, Schütz G. Primary structure, chromosomal mapping, expression and transcriptional activity of murine hepatocyte nuclear factor 4gamma. Biochim Biophys Acta. 2 — View Citation

Watanabe T, Kobunai T, Toda E, Kanazawa T, Kazama Y, Tanaka J, Tanaka T, Yamamoto Y, Hata K, Kojima T, Yokoyama T, Konishi T, Okayama Y, Sugimoto Y, Oka T, Sasaki S, Ajioka Y, Muto T, Nagawa H. Gene expression signature and the prediction of ulcerative co — View Citation

Wille JJ, Kydonieus A. Palmitoleic acid isomer (C16:1delta6) in human skin sebum is effective against gram-positive bacteria. Skin Pharmacol Appl Skin Physiol. 2003 May-Jun;16(3):176-87. — View Citation

Wisely GB, Miller AB, Davis RG, Thornquest AD Jr, Johnson R, Spitzer T, Sefler A, Shearer B, Moore JT, Miller AB, Willson TM, Williams SP. Hepatocyte nuclear factor 4 is a transcription factor that constitutively binds fatty acids. Structure. 2002 Sep;10( — View Citation

Wu F, Dassopoulos T, Cope L, Maitra A, Brant SR, Harris ML, Bayless TM, Parmigiani G, Chakravarti S. Genome-wide gene expression differences in Crohn's disease and ulcerative colitis from endoscopic pinch biopsies: insights into distinctive pathogenesis. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and endoscopic remission	We will perfom a basal and final colonoscopy	2 months	Yes
Secondary	quantification IL-6 in colonic mucosa	quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention.	2 months	Yes