Table of contents
- Trial overview
- Who is being studied
- What the trials measure
- Trial phases and study size
- Key study types and settings
- Patient-friendly terms
Trial overview
The trial data provided here include studies that use Sodium Sulfate Anhydrous in bowel preparation and digestive research settings.[1] The main focus is not on the substance itself, but on how well the preparation works for tests such as colonoscopy, capsule endoscopy, and other digestive procedures.[1]
Several studies compare one preparation with another, while others test how a preparation affects the quality of a medical exam or a clinical outcome.[1][2] The studies are spread across different patient groups and different disease areas.[1][3]
Who is being studied
The target populations are varied. Some trials include people scheduled for elective colonoscopy or colorectal cancer screening, while others include patients with Crohn’s disease, fecal incontinence, hip fracture, recurrent urinary tract infections, axial spondyloarthritis, or major poisoning in intensive care.[1][2][3]
One study focuses on patients with unresectable hepatocellular carcinoma, which means liver cancer that cannot be removed by surgery.[4] Another study looks at patients undergoing small bowel capsule endoscopy, and one study evaluates people after intra-rectal botulinum toxin injections for fecal incontinence.[5][6]
What the trials measure
The most common main outcome is bowel cleansing quality, which means how clean the bowel is before or during the test.[1][7] In the capsule endoscopy study, the primary outcome is the degree of small bowel cleansing using an accepted cleansing scale.[1]
In the colonoscopy studies, researchers measure whether cleansing is adequate, often using the BBPS score, which is a standard bowel cleanliness score.[2] In the colorectal cancer screening trial, the main outcome is the adenoma detection rate, meaning the proportion of patients in whom at least one adenoma is found.[7]
Other studies measure different clinical outcomes. For example, one trial measures the time to onset of high amplitude propagative contractions after laxative instillation, and another measures the proportion of patients needing rescue medication after 72 hours after hip surgery.[2][3] The hepatocellular carcinoma study measures both safety, through serious adverse events, and efficacy, through disease control rate at 12 weeks.[4]
The Crohn’s disease ultrasound study measures whether the terminal ileum lumen fills evenly with contrast and whether the bowel wall can be clearly separated from the lumen.[5] The recurrent urinary tract infection study measures the rate of new infection episodes within 180 days after treatment.[6]
Trial phases and study size
Most of the studies are Phase 2 or Phase 3 trials.[1][2][3] Phase 2 trials usually explore whether a strategy works in a smaller group, while Phase 3 trials are larger and compare approaches more fully.
One study is listed as a low-intervention trial, which means the research approach is lighter than a standard intervention study.[1] Enrollment ranges from very small studies, such as 15 or 21 participants, to large studies with 818 participants.[2][4][7]
Key study types and settings
Bowel preparation studies are the largest group. These studies look at how well a preparation cleans the bowel before colonoscopy or capsule endoscopy, and whether the cleansing is good enough for the doctor to see the lining clearly.[1][7]
Digestive motility research is also included. In the fecal incontinence study, researchers look at bowel movement patterns after rectal treatment and use manometry, a test that measures pressure and muscle activity in the bowel.[2]
Disease-specific research appears in Crohn’s disease, axial spondyloarthritis, and hepatocellular carcinoma. These studies use bowel-related preparation or microbiota-related treatment as part of a wider clinical question.[4][5][8]
Supportive care studies are also included, such as the hip surgery trial and the intensive care poisoning study, where the goal is to improve bowel management or reduce absorption of toxic substances.[3][9]
Patient-friendly terms
Adenoma detection rate means how often a colonoscopy finds a polyp-like growth that can matter for cancer screening.[7] Recue medication in the hip surgery study means extra treatment needed if the main plan does not work well enough.[3]
RECIST 1.1 is a standard way to judge whether cancer is shrinking, staying stable, or growing.[4] Disease control in that study means complete response, partial response, or stable disease.[4]
High amplitude propagative contractions are strong bowel contractions that move stool forward.[2] Terminal ileum is the last part of the small bowel, and it is a key area in Crohn’s disease imaging.[5]
