Table of contents

• Trial overview
• Study populations and who can join
• Study phases and design
• Main endpoints and what is measured
• Key trial examples
• What these studies may mean for patients

Trial overview

The clinical trial data provided here focus on studies that investigate bowel preparation and related digestive procedures, with several trials using Sodium Sulfate Anhydrous as part of the research context or preparation regimens.^[1][2] These studies look at how well the bowel is cleaned, how clearly the bowel lining can be seen, and how well doctors can make a diagnosis during tests such as capsule endoscopy and colonoscopy.^[1][4]

The trials are not all in the same disease area. Some are about colorectal cancer screening, while others involve Crohn’s disease, fecal incontinence, hip fracture, recurrent urinary tract infections, axial spondyloarthritis, and severe poisoning in intensive care.^{[2][3][5][6][7][8][9][10]}

Study populations and who can join

The target groups differ from study to study. In some trials, the participants are people scheduled for elective colonoscopy or capsule endoscopy, which means the study is linked to a planned bowel examination.^[1][4]

Other studies recruit people with specific health problems, such as Crohn’s disease, fecal incontinence, or hip fracture.^[6][2][3] There are also studies for people with unresectable hepatocellular carcinoma, recurrent urinary tract infections, and axial spondyloarthritis.^[5][8][9]

One intensive care study is limited to major patients who are intoxicated by functional toxicants, are hospitalized in intensive care, and are intubated, meaning a breathing tube is in place.^[7] This shows that the research is very specific and depends on the illness and the clinical situation.^[7]

Study phases and design

The dataset includes both Phase 2 and Phase 3 trials, plus one low-intervention study.^{[1][2][3][4][5][6][7][8][9][10]}

A Phase 2 study usually looks at early signs of benefit and safety in a smaller group, while a Phase 3 study is larger and compares strategies more directly.^{[2][3][4][5][6][8][9][10]} The studies are interventional, which means the researchers assign a preparation or treatment and then measure the results.^{[1][2][3][4][5][6][7][8][9][10]}

Some trials are randomized, which means people are placed by chance into different groups.^{[4][5][8][10]} One colonoscopy study is also described as multicenter and endoscopist-blinded, meaning the doctor who looks at the bowel does not know which group the patient was in.^[4]

Main endpoints and what is measured

The most common primary outcome is bowel cleansing quality.^[1][4] In the capsule endoscopy study, the outcome is the degree of small bowel cleansing using an accepted cleansing scale.^[1]

In the colonoscopy study, the main endpoint is the proportion of patients with adequate bowel cleansing, defined by a Boston Bowel Preparation Scale total score of at least 6 and a score of at least 2 in each colon segment after washing and air or carbon dioxide insufflation.^[4] This is a formal way to say that the bowel must be clean enough in all main sections for a good examination.^[4]

Other studies measure different outcomes. In the fecal incontinence trial, researchers measure the time to onset of high amplitude propagative contractions after DULCOLAX instillation before and one month after botulinum toxin injections.^[2] In the hip fracture study, the main outcome is how many patients need rescue medication after 72 hours or before 72 hours based on medical assessment.^[3]

In Crohn’s disease, the study measures whether the whole terminal ileum can be filled with contrast and clearly separated from the bowel wall within one hour.^[6] In the intensive care poisoning study, the main outcome is the percentage change in plasma concentration of the toxic substance at 24 hours compared with randomization.^[7]

Some studies also look at broader patient outcomes, such as disease control in liver cancer, new urinary tract infection episodes within 180 days, change in disease scores in axial spondyloarthritis, and adenoma detection rate in colorectal cancer screening.^{[5][8][9][10]}

Key trial examples

Capsule endoscopy preparation study: This authorised low-intervention study includes 156 participants and compares preparation protocols to assess how well the small bowel is cleaned and how well the mucosa can be seen during capsule endoscopy.^[1]

MECA-TOX: This Phase 3 study includes 21 participants with fecal incontinence and examines rectal motility, using the time to onset of high amplitude propagative contractions as the main endpoint.^[2]

What laxatives after hip surgery?: This Phase 3 study includes 375 participants with hip fracture and looks at whether patients need rescue medication after surgery to help prevent constipation.^[3]

CLEARWAY: This completed Phase 3 study includes 520 people scheduled for elective colonoscopy and compares bowel cleansing quality, with adequate cleansing defined by a validated score.^[4]

RESCUE-HUB: This authorised Phase 2 study includes 15 participants with unresectable hepatocellular carcinoma and measures safety and disease control after fecal microbiota transplantation added to first-line treatment.^[5]

SonoDOCc 2: This authorised Phase 2 study includes 104 participants with Crohn’s disease and evaluates whether the terminal ileum can be clearly visualized using transabdominal ultrasound and microbubbles as contrast.^[6]

DIMREATOX: This authorised Phase 2 study includes 200 intubated intensive care patients with poisoning and measures the change in plasma toxicant levels after combined digestive decontamination.^[7]

FEMITRANS: This authorised Phase 2 study includes 24 premenopausal women with recurrent urinary tract infections and measures the number of new infection episodes within 180 days after treatment.^[8]

Fecal Microbiota Transplantation Trial in Axial Spondyloarthritis: This authorised Phase 2 study includes 25 people with axial spondyloarthritis and measures microbiota change and symptom improvement at day 42.^[9]

CLEAN+: This authorised Phase 3 study includes 818 participants in colorectal cancer screening and measures adenoma detection rate during colonoscopy.^[10]

What these studies may mean for patients

For patients, these trials are mainly about making bowel tests work better and more reliably.^[1][4] Better cleansing can help doctors see more clearly, which may improve the quality of the examination and the chance of finding important changes.^[1][4][10]

Some studies are not about bowel preparation alone. They also explore whether a digestive preparation or related approach can help with symptoms, infection prevention, microbiota changes, or reduction of toxic substances in the body.^[5][7][8][9]

Because the studies are designed for different groups, the best match depends on the person’s condition, planned procedure, and study criteria.^{[1][2][3][4][5][6][7][8][9][10]}