Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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 May 19, 2013