LB1148 for Bowel Resection

(PROFILE Trial)

Recruiting at 38 trial locations

Overseen By Torrie Magee

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Leading BioSciences, Inc

Must not be taking: Hormonal contraceptives, Alvimopan

Disqualifiers: Age, IBD, Seizure disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 days

112 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot use certain medications like alvimopan or 4% icodextrin during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.

How is the drug LB1148 different from other treatments for bowel resection?

LB1148 is unique because it is designed to protect the intestines during surgery, potentially reducing complications like postoperative ileus (a temporary lack of movement in the intestines). Unlike other treatments that may focus on resolving symptoms after they occur, LB1148 aims to prevent these issues from developing in the first place. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing LB1148, a treatment to help patients recover bowel function and reduce internal scar tissue after bowel surgery. It targets patients who are having elective bowel resection surgery. The treatment aims to speed up the return of normal bowel movements and prevent complications from internal scarring.

Research Team

Mitch Jones, MD

Principal Investigator

CMO

Eligibility Criteria

Inclusion Criteria

Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.

Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided written informed consent.

Willing to perform and comply with all study procedures including attending clinic visit as scheduled and completion of a second surgery for stoma takedown or other abdominal surgery and to determine the presence of intra-abdominal adhesions.

Exclusion Criteria

Received any other investigational therapy within 4 weeks prior to Randomization

You need to have urgent surgery on your intestines.

American Society of Anesthesiologists (ASA) Class 4 or 5.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LB1148 or placebo during and after elective bowel resection surgery to evaluate return of gastrointestinal function and reduction of post-operative ileus and intra-abdominal adhesions

Up to 14 days

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of intra-abdominal adhesions

Up to 8 months

Treatment Details

Interventions

• LB1148
• Placebo

Participant Groups

Group I: LB1148 Experimental Treatment 1 Intervention

Active

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Leading BioSciences, Inc

Lead Sponsor

Trials

3

Recruited

120+

Palisade Bio

Lead Sponsor

Trials

3

Recruited

230+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of bisacodyl suppository versus placebo for postoperative ileus after elective colectomy for colon cancer. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A pilot study of factors influencing bowel function after colorectal anastomosis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Is evaluation by questionnaires sufficient to cover all aspects of bowel symptoms in rectal cancer patients after low anterior resection? [2022]