Bovine Colostrum for Patients With Non Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To determine the efficacy of BCP in improving liver enzyme levels in patients with NASH.
研究概览
简要总结
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.
详细描述
- HYPOTHESIS AND STUDY OBJECTIVES
1.1. HYPOTHESIS
Ingestion of bovine colostrum powder (BCP) from cows immunized to insulin will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions
1.2. PRIMARY OBJECTIVES
1.2.1 To determine the efficacy of BCP in improving liver enzyme levels in patients with NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
To determine the efficacy of BCP in improving liver enzyme levels in patients with NASH.
时间窗: 4 weeks
To determine the safety of the administration of oral BCP to patients with NASH.
时间窗: 8 weeks
次要结局
- To determine whether the administration of BCP will improve the metabolic syndrome in patients with NASH (namely insulin resistance).(4)