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Effect of FAn-7 in UC Activity (FAUC)

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis

Status
Unknown status
Phase
Early Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Palmitoleic acid
Sponsored by
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Palmitoleic acid ulcerative colitis

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • INCMNSZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

palmitoleic acid

Sugar pill

Arm Description

Palmitoleic acid: 720 mg/day for 56 days

Sugar pill: 720 mg/day for 56 days

Outcomes

Primary Outcome Measures

clinical and endoscopic remission
We will perfom a basal and final colonoscopy

Secondary Outcome Measures

quantification IL-6 in colonic mucosa
quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention.

Full Information

First Posted
January 16, 2013
Last Updated
January 16, 2013
Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT01771224
Brief Title
Effect of FAn-7 in UC Activity
Acronym
FAUC
Official Title
Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4γ and Ulcerative Colitis (UC) Activity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis
Keywords
Palmitoleic acid ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
palmitoleic acid
Arm Type
Experimental
Arm Description
Palmitoleic acid: 720 mg/day for 56 days
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Sugar pill: 720 mg/day for 56 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Palmitoleic acid
Intervention Description
Palmitoleic acid and 5-ASA
Primary Outcome Measure Information:
Title
clinical and endoscopic remission
Description
We will perfom a basal and final colonoscopy
Time Frame
2 months
Secondary Outcome Measure Information:
Title
quantification IL-6 in colonic mucosa
Description
quantification of IL-6 by RT-PCR in colonic mucosa at before and after the intervention.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus K Yamamoto, MD, PhD
Phone
54870900
Ext
2710
Email
kazuofurusho@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nallely Bueno, MSc
Phone
54870900
Ext
2712
Email
nallely_bh5@yahoo.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús K Yamamoto, MD, PhD
Organizational Affiliation
Inflammatory Bowel Disease Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nallely Bueno, MSc
Organizational Affiliation
Inflammatory Bowel Disease Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCMNSZ
City
DF
State/Province
Tlalpan
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus K Furusho, MD, PhD
Phone
+5554870900
Ext
2710
Email
kazuofurusho@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nallely Bueno, MSc
Phone
+5554870900
Ext
2712
Email
nallely_bh5@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Jesus K Yamamoto, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nallely Bueno, MSc

12. IPD Sharing Statement

Citations:
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Effect of FAn-7 in UC Activity

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