Effect of FAn-7 in UC Activity (FAUC)

N

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Status and phase

Unknown
Early Phase 1

Conditions

Inflammatory Bowel Disease
Ulcerative Colitis

Treatments

Dietary Supplement: Palmitoleic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01771224
REF453

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

palmitoleic acid
Experimental group
Description:
Palmitoleic acid: 720 mg/day for 56 days
Treatment:
Dietary Supplement: Palmitoleic acid
Sugar pill
Placebo Comparator group
Description:
Sugar pill: 720 mg/day for 56 days

Trial contacts and locations

1

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Central trial contact

Nallely Bueno, MSc; Jesus K Yamamoto, MD, PhD

Data sourced from clinicaltrials.gov

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