A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules: Safety, Tolerability, Feasibility, and Preliminary Cleansing Effectiveness
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Capsule ingestion completion
研究概览
简要总结
The goal of this clinical trial is to learn whether bowel preparation powders used before colonoscopy can be taken as capsules instead of being mixed and drunk as a liquid. Bowel preparation is the medicine people take to clean the bowel before a colonoscopy.
This study will include adults aged 18 to 75 years who are already scheduled for an outpatient colonoscopy and who have had a colonoscopy before.
The main questions this study aims to answer are:
- Can participants swallow and complete a large number of bowel preparation capsules with the required clear fluids?
- Can the capsules be prepared accurately and practically by a pharmacy or by participants at home?
- Is the capsule-based bowel preparation safe and well tolerated?
- Does the capsule-based bowel preparation clean the bowel well enough for colonoscopy?
Participants will take approved bowel preparation products, Pico-Salax or Bi-PegLyte, in vegan hydroxypropyl methylcellulose capsules. They will take the capsules with clear fluids using a split-dose schedule before colonoscopy.
The study will happen in three parts. First, researchers will test two capsule sizes using Pico-Salax capsules prepared by a partner pharmacy. Then, researchers will test Bi-PegLyte capsules using the capsule size selected from the first part. Finally, some participants will prepare the capsules themselves at home using study instructions and materials.
Researchers will measure how many capsules and how much fluid participants complete, symptoms during preparation, safety blood tests, participant satisfaction, and bowel cleanliness during colonoscopy.
详细描述
This is a prospective, single-site, open-label, sequential, non-randomized pilot feasibility study of capsule-based bowel preparation before colonoscopy.
The study will evaluate whether approved commercially available bowel preparation powders can be administered in vegan hydroxypropyl methylcellulose capsules instead of being mixed into a liquid solution before ingestion. The approved products used in this study are Pico-Salax and Bi-PegLyte. The active products, total approved dose, oral route, required clear-fluid intake, and split-dose timing will be preserved. The investigational aspect is the capsule-based method of administration.
The rationale for the study is that many people find liquid bowel preparation difficult to complete because of taste, texture, nausea, and the amount of liquid required. Capsule-based administration may reduce exposure to unpleasant taste and mouthfeel while maintaining the intended bowel cleansing effect, provided participants drink the required clear fluids.
The study will enroll adults aged 18 to 75 years who are scheduled for elective outpatient colonoscopy for screening, surveillance, or diagnostic indications and who have previously completed a conventional bowel preparation. Participants must be able to swallow solids, liquids, and pills without difficulty.
The study will proceed in three sequential parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. No participants, care providers, investigators, or outcome assessors are masked to the assigned capsule-based bowel preparation regimen or study part.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 75 years.
- •Scheduled for elective outpatient colonoscopy for a screening, surveillance, or diagnostic indication.
- •Has previously undergone colonoscopy using a conventional bowel preparation solution, without requiring repeat colonoscopy because of poor bowel preparation.
- •Able to provide informed consent.
- •Willing and able to comply with study procedures, including timed dosing, required clear-fluid intake, and capsule preparation procedures for participants enrolled in Part III.
- •Able to swallow solids, liquids, and pills without difficulty.
排除标准
- •Higher risk for clinically significant fluid or electrolyte shifts, including chronic renal impairment, severely reduced renal function, congestive cardiac failure, unstable cardiovascular disease, or any other condition in which large-volume fluid intake or rapid catharsis may be unsafe.
- •Baseline clinically significant electrolyte abnormalities.
- •Diabetes mellitus, gastroparesis, gastric retention, intestinal dysmotility, or any other condition that may impair gastric emptying, gastrointestinal transit, mixing, dissolution, or passage of the bowel preparation.
- •Current use of medications that may impair gastrointestinal motility or safe bowel preparation completion, including opioid medications, anticholinergic medications, or glucagon-like peptide-1 receptor agonists.
- •Known or suspected gastrointestinal obstruction, bowel obstruction, ileus, bowel perforation, gastrointestinal perforation, or any condition associated with increased risk of obstruction or perforation.
- •Acute abdominal or gastrointestinal condition in which bowel preparation may be unsafe, including acute surgical abdomen, acute appendicitis, gastroenteritis, diverticulitis, toxic colitis, toxic megacolon, severe colitis requiring urgent care, or another acute inflammatory, infectious, or structural gastrointestinal condition judged by the investigator to make participation unsafe.
- •Known gastrointestinal ulceration or clinically significant active gastrointestinal bleeding, including unexplained rectal bleeding.
- •Active nausea or vomiting at screening or before bowel preparation administration that, in the opinion of the investigator, would interfere with safe ingestion of the assigned capsule-based bowel preparation regimen.
- •Emergency colonoscopy, including colonoscopy for lower gastrointestinal bleeding or any clinical condition requiring urgent endoscopic evaluation that would not allow adherence to the study bowel preparation protocol.
- •Known hypersensitivity, allergy, or intolerance to Bi-PegLyte, Pico-Salax, bisacodyl, polyethylene glycol, sodium picosulfate, magnesium oxide, citric acid, electrolytes contained in the formulations, HPMC/hypromellose capsules, or any ingredient in the formulation or product container.
- •Pregnancy or known or suspected pregnancy at screening or before bowel preparation administration.
- •Capsule-specific feasibility or safety concern, including dysphagia, esophageal dysmotility, achalasia, esophageal stricture, high risk of aspiration, anatomical abnormality affecting swallowing, or any condition in which swallowing a large number of capsules is considered unsafe.
- •Practical or adherence-related concern, including inability to follow timed dosing instructions, inability to comply with the required clear-fluid intake, lack of reliable contact, or anticipated nonadherence to study procedures.
- •For Part III only: inability or unwillingness to self-prepare capsules using study-provided materials and instructions; inadequate manual dexterity or vision to prepare capsules safely and accurately; inability to complete the teach-back procedure, if required; or unwillingness to follow the standardized home preparation workflow, including use only of study-supplied materials, preparation within the defined time window, and storage as instructed.
- •Any contraindication listed in the product monograph for Bi-PegLyte or Pico-Salax.
研究组 & 干预措施
Capsule-Based Bowel Preparation
Participants receive capsule-based bowel preparation before elective outpatient colonoscopy. The study is conducted sequentially in three parts: Part I evaluates centrally prepared Pico-Salax capsules using size "000" and size "00" HPMC capsules; Part II evaluates centrally prepared Bi-PegLyte capsules using the capsule size selected after Part I; and Part III evaluates participant-prepared Pico-Salax or Bi-PegLyte capsules at home using study-supplied materials and instructions. All regimens use approved marketed bowel preparation products at their approved dose with required clear-fluid intake and split-dose timing.
干预措施: Sodium picosulfate, magnesium oxide, and citric acid capsules (Drug)
Capsule-Based Bowel Preparation
Participants receive capsule-based bowel preparation before elective outpatient colonoscopy. The study is conducted sequentially in three parts: Part I evaluates centrally prepared Pico-Salax capsules using size "000" and size "00" HPMC capsules; Part II evaluates centrally prepared Bi-PegLyte capsules using the capsule size selected after Part I; and Part III evaluates participant-prepared Pico-Salax or Bi-PegLyte capsules at home using study-supplied materials and instructions. All regimens use approved marketed bowel preparation products at their approved dose with required clear-fluid intake and split-dose timing.
干预措施: Polyethylene glycol 3350 with electrolytes capsules (Drug)
结局指标
主要结局
Capsule ingestion completion
时间窗: From first capsule ingestion through colonoscopy, approximately 24 hours
Proportion of participants who ingest at least 80% of the prescribed bowel preparation capsules within the protocol-defined dosing window.
Clear-fluid intake completion
时间窗: From first capsule ingestion through colonoscopy, approximately 24 hours
Proportion of participants who complete the required clear-fluid intake according to the protocol-defined bowel preparation schedule.
Completion without premature discontinuation due to capsule burden or swallowing difficulty
时间窗: From first capsule ingestion through colonoscopy, approximately 24 hours
Proportion of participants who complete the capsule-based bowel preparation without stopping early because of capsule burden, swallowing difficulty, or intolerance related to capsule ingestion.
Capsule preparation feasibility
时间窗: From capsule preparation through colonoscopy, up to 7 days
Feasibility of capsule preparation, including the proportion of participants in Part III who prepare at least 80% of required capsules, capsule count reconciliation relative to expected dose, time required for capsule preparation, and participant-reported difficulty and confidence in preparation accuracy.
次要结局
- Participant-reported nausea(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Participant-reported overall tolerability(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Participant-reported vomiting(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Participant-reported abdominal discomfort(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Participant-reported dizziness(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Participant-reported swallowing difficulty(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Treatment-emergent adverse events(From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours)
- Serious adverse events(From first capsule ingestion through 24 hours after colonoscopy)
- Change in serum electrolytes and creatinine(Baseline within 1 week before bowel preparation and repeat assessment on the day of colonoscopy)
- Adequate bowel preparation by Boston Bowel Preparation Scale(During colonoscopy on Day 0)
- Total Boston Bowel Preparation Scale score(During colonoscopy on Day 0)
- Cecal intubation rate(During colonoscopy on Day 0)
- Need for rescue measures or early repeat colonoscopy(During colonoscopy on Day 0)