Bovine Colostrum for Patients With Non Alcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01016418
First received: November 18, 2009
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

Trial Synopsis: Bovine Colostrum for patients with non alcoholic fatty liver disease (NAFLD).

Design: This is a single-arm, open-label, before-and after exploratory trial of 30 days of Bovine Colostrum Powder (BCP) to improve NAFLD and the metabolic syndrome.

Duration: 8 weeks per subject.

Sample Size: 30 subjects.

Population: Patients with biopsy proven NASH (NAS of > 4) and an ALT level of ≥ 30 (U/L).

Regimen Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for safety monitoring for an additional 4 weeks.


Condition Intervention Phase
Nonalcoholic Steatohepatitis
Fatty Liver Disease
Dietary Supplement: Bovine colostrum powder
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • To determine the efficacy of BCP in improving liver enzyme levels in patients with NASH. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • To determine the safety of the administration of oral BCP to patients with NASH. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine whether the administration of BCP will improve the metabolic syndrome in patients with NASH (namely insulin resistance). [ Time Frame: 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bovine colostrum powder
Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for safety monitoring for an additional 4 weeks.
Dietary Supplement: Bovine colostrum powder
Study treatment will consist of BCP, three 1.2 g oral tablets (equivalent to 600 mg of BCP each) for 4 weeks, from cows immunized to insulin. Patients will be followed for safety monitoring for an additional 4 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven NASH (NAS score ≥ 4)
  • Serum ALT levels ≥ 30 (U/L)
  • Age 18-65
  • Treatment of diabetes by up to 2 oral medications, with stable doses for 2 months
  • If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication.NOTE: Hormonal-based methods alone are not sufficient. At least two of the following methods MUST be used appropriately unless documentation of menopause, sterilization, or azoospermia is present:

    • Condoms (male or female) with or without a spermicidal agent. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission
    • Diaphragm or cervical cap with spermicide
    • IUD
    • Hormonal-based contraception
  • Study subjects who are not of reproductive potential (girls who have not reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy) are eligible without requiring the use of contraceptives.
  • Written or oral documentation communicated by clinician or clinician's staff is required by one of the following:

    • Physician report/letter
    • Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)
    • Discharge summary
    • Laboratory report of azoospermia
    • FSH measurement elevated into the menopausal range as established by the reporting laboratory
  • Ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria:

  • Pregnancy or Breast-Feeding
  • Continuous use of the following medications for more than 3 days within 30 days of study entry:

    • Immunosuppressives
    • Immune modulators
    • Systemic glucocorticoids
    • Anti-neoplastic agents
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
  • Operation within the previous 3 months
  • A serious infectious, cardiac, pulmonary, or nephrological disease
  • Allergic to cow milk or lactose intolerant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016418

Locations
Israel
Liver Unit, Hadassah, Ein Kerem
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Gadi Lalazar, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT01016418     History of Changes
Other Study ID Numbers: NASH Colostrum - HMO - CTIL
Study First Received: November 18, 2009
Last Updated: September 16, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
NASH
fatty liver disease
colostrum

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 01, 2014