NCT01771224

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 16, 2013

Last Update Submit

January 16, 2013

Conditions

Inflammatory Bowel DiseaseUlcerative Colitis

Keywords

Palmitoleic acid ulcerative colitis

Outcome Measures

Primary Outcomes (1)

  • clinical and endoscopic remission

    We will perfom a basal and final colonoscopy

    2 months

Secondary Outcomes (1)

  • quantification IL-6 in colonic mucosa

    2 months

Study Arms (2)

palmitoleic acid

EXPERIMENTAL

Palmitoleic acid: 720 mg/day for 56 days

Dietary Supplement: Palmitoleic acid

Sugar pill

PLACEBO COMPARATOR

Sugar pill: 720 mg/day for 56 days

Interventions

Palmitoleic acidDIETARY_SUPPLEMENT

Palmitoleic acid and 5-ASA

palmitoleic acid

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCMNSZ

DF, Tlalpan, 14000, Mexico

RECRUITING

Related Publications (13)

  • Bueno-Hernandez N, Sanchez-Munoz F, Barreto-Zuniga R, Dominguez-Lopez A, Yamamoto-Furusho JK. Expression of HNF4gamma is downregulated in patients with active ulcerative colitis (UC) compared to UC patients in remission and healthy controls. Inflamm Bowel Dis. 2011 Aug;17(8):E91. doi: 10.1002/ibd.21753. Epub 2011 May 25. No abstract available.

    PMID: 21618351RESULT

  • 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. doi: 10.1128/MCB.16.3.925.

    PMID: 8622695RESULT

  • 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.

    PMID: 22941427RESULT

  • 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-4alpha (HNF4alpha) isoforms, phosphorylation status, and interactive cofactors. J Biol Chem. 2011 Jan 7;286(1):674-86. doi: 10.1074/jbc.M110.154732. Epub 2010 Nov 3.

    PMID: 21047794RESULT

  • Nieto N, Torres MI, Rios 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. doi: 10.1093/jn/132.1.11.

    PMID: 11773501RESULT

  • 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. doi: 10.1136/gut.28.8.1002.

    PMID: 3117625RESULT

  • 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):908-20. doi: 10.1002/ibd.20413.

    PMID: 18338782RESULT

  • Taraviras S, Mantamadiotis T, Dong-Si T, Mincheva A, Lichter P, Drewes T, Ryffel GU, Monaghan AP, Schutz G. Primary structure, chromosomal mapping, expression and transcriptional activity of murine hepatocyte nuclear factor 4gamma. Biochim Biophys Acta. 2000 Jan 31;1490(1-2):21-32. doi: 10.1016/s0167-4781(99)00232-8.

    PMID: 10786614RESULT

  • 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 colitis-associated colorectal cancer by DNA microarray. Clin Cancer Res. 2007 Jan 15;13(2 Pt 1):415-20. doi: 10.1158/1078-0432.CCR-06-0753.

    PMID: 17255260RESULT

  • 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. doi: 10.1159/000069757.

    PMID: 12677098RESULT

  • 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(9):1225-34. doi: 10.1016/s0969-2126(02)00829-8.

    PMID: 12220494RESULT

  • 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. No abstract available. Japanese.

    PMID: 5539258RESULT

  • 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. Inflamm Bowel Dis. 2007 Jul;13(7):807-21. doi: 10.1002/ibd.20110.

    PMID: 17262812RESULT

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, Ulcerative

Interventions

palmitoleic acid

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Jesús K Yamamoto, MD, PhD

    Inflammatory Bowel Disease Clinic

    STUDY DIRECTOR

  • Nallely Bueno, MSc

    Inflammatory Bowel Disease Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus K Yamamoto, MD, PhD

CONTACT

54870900kazuofurusho@hotmail.com

Nallely Bueno, MSc

CONTACT

54870900nallely_bh5@yahoo.com.mx

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

January 18, 2013

Record last verified: 2012-01

Locations

ME(1)