NCT05106101已完成1 期
A Pilot/Phase 1, Interventional, Open-label, Multi-center Study to Assess the Safety and Efficacy of L-glutamine Treatment in Patients With Diverticulosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
研究概览
简要总结
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4 weeks screening period to determine eligibility for study entry. At Week 0, patients who meet eligibility requirements will be given L-glutamine (15 grams, twice daily)
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 years of age.
- •Uncomplicated diverticulosis confirmed by colonoscopy.
- •Colonoscopy indicates ≥5 colonic diverticula (pouches) in the descending/sigmoid colon and < approximately10 colonic diverticula (pouches) per segment (e.g. proximal descending, distal descending, proximal sigmoid, and distal sigmoid.)
- •If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence).
- •Patients who have given their free and written informed consent.
排除标准
- •Acute diverticulitis (both complicated and uncomplicated).
- •Acute colitis
- •History of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation.
- •Active bleeding
- •More than 40 diverticula
- •Chronic renal insufficiency
- •Chronic liver disease.
- •Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female of childbearing potential).
- •Inability to give a valid informed consent or to properly follow the protocol.
- •Patients with an active malignancy of any type, or a recent history of malignancy within the last 5 years.
- •Treated with an investigational medication/treatment within 30 days prior to the screening visit.
- •Currently enrolled in an Investigational study
- •Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit.
- •Previous difficulty pulling or passing of scope or difficulty completing colonoscopy.
- •There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
研究组 & 干预措施
L-glutamine
Experimental
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
干预措施: L-glutamine (Drug)
结局指标
主要结局
Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
时间窗: Baseline, 6 months and 12 months
Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months
次要结局
- Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis(Baseline, 6 month and 12 months)
- Effect of oral L-glutamine on Hematological Parameters - Hemoglobin(Baseline to 48 weeks (12 months))
- Effect of oral L-glutamine on Hematological Parameters - Hematocrit(Baseline to 48 weeks (12 months))
- Effect of oral L-glutamine on Vital Signs - Blood Pressure(Baseline to 48 weeks (12 months))
- Effect of oral L-glutamine on Vital Signs - Temperature(Baseline to 48 weeks (12 months))
- Effect of oral L-glutamine on Vital Signs - Pulse Rate(Baseline to 48 weeks (12 months))
- Effect of oral L-glutamine on Vital Signs - Respiration(Baseline to 48 weeks (12 months))
研究者
研究点 (3)
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