NCT01313910已完成早期 1 期
CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Bowel Movements Per Day
研究概览
简要总结
The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel movements and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms. The study will also examine the effect of ImmunoLin® on the bacteria in the gut and the immune system in gut tissue as well as in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GI complaints consisting of at least 2 loose or watery stools per day or marked abdominal bloating that adversely effects activities of daily living (ADLs) or common social functioning for greater than 6 months, even though the symptomatology may wax and wane over that time period.
- •Subjects should have had routine testing to exclude enteric pathogens.
- •Subjects should have made an effort to identify food intolerance, especially lactose intolerance.
- •Symptoms should be believed to be independent of ART or other medications known to have the potential to cause similar GI complaints; either because the symptoms predate initiation of the medications or shifts between different options for ART has had no appreciable effect on symptoms.
- •Over the previous 6 months, alcohol use should be characterized as occasional with less than 1.5 ounces per day being the maximum estimated use (<2 beers or glasses of wine or 1 drink of hard liquor).
- •Subjects will be greater than 18 years of age.
- •Plasma HIV load should be suppressed to less than 400 cp/mL for at least four months, but there is no restriction on peripheral CD4+ T-cell count. Blips of <1000 cp/mL are allowed, provided that these are not associated with medication interruptions and that the pVL is undetectable before and after the observed blip.
- •Subjects are willing to maintain a food and GI-symptom diary while receiving the ImmunoLin® supplement.
- •Subjects should be willing to attempt to maintain a stable regimen of ART for the duration of the study unless indicated for patient safety.
- •Subjects should be free of antibiotic use for at least 3-weeks prior to study entry except for chronic antibiotics used for prophylaxis according to SOC in HIV management. Usage of antibiotics during the course of the study will be assessed on a case by case basis by the study team.
- •Subjects must be free of conditions which require chronic therapy that are known to alter the gut flora. Steroid use must be limited to intermittent topical preparations only which includes inhaled or dermatologic routes of application.
排除标准
- •known unrelated causes for GI abnormalities.
- •abnormal coagulation parameters (PT>1.2 ULN)
- •thrombocytopenia (platelet count <50,000 within 6 weeks)
- •contra-indications to upper endoscopy or conscious sedation
- •anemia (> grade 1 [appendix D])
- •aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
- •positive pregnancy test
结局指标
主要结局
Number of Bowel Movements Per Day
时间窗: 8 weeks (56 days)
self-reported bowel movement in diary
次要结局
- Frequency of Pro-inflammatory Bacterial Orders(8 weeks)
- Measures of Gut Permeability(8 weeks)
- Duodenal Immune Reconstitution(8 weeks)
- Systemic Immune Activation(8 weeks)
研究者
研究点 (2)
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