Bovine Colostrum for Patients With Non Alcoholic Fatty Liver Disease

NCT01016418 | Completed Phase 1 DMC

• 1 other identifier: NASH Colostrum - HMO - CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nonalcoholic Steatohepatitis; Fatty Liver Disease

Keywords

NASH; fatty liver disease; colostrum

Outcome Measures

Primary Outcomes (2)

• To determine the efficacy of BCP in improving liver enzyme levels in patients with NASH.

  4 weeks

• To determine the safety of the administration of oral BCP to patients with NASH.

  8 weeks

Secondary Outcomes (1)

• To determine whether the administration of BCP will improve the metabolic syndrome in patients with NASH (namely insulin resistance).

  4

Study Arms (1)

Bovine colostrum powder

EXPERIMENTAL

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

Interventions

Bovine colostrum powder DIETARY_SUPPLEMENT

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.

Bovine colostrum powder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Liver Unit, Hadassah, Ein Kerem

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Kim JH, Jung WS, Choi NJ, Kim DO, Shin DH, Kim YJ. Health-promoting effects of bovine colostrum in Type 2 diabetic patients can reduce blood glucose, cholesterol, triglyceride and ketones. J Nutr Biochem. 2009 Apr;20(4):298-303. doi: 10.1016/j.jnutbio.2008.04.002. Epub 2008 Jul 7.

  PMID: 18602824 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

IL (1)