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Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome

ConditionShort Bowel Syndrome
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLindsey Russell, MD

About this trial

The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial and be willing to complete the required assessments;

Male and female patients aged ≥ 18 years;

Patients with history of SBS resulting in intestinal failure caused by a major intestinal resection (e.g., injury, cancer, Crohn's disease, vascular disease, volvulus, intussusceptions or other causes). Diagnosis of SBS will be defined as remaining small bowel excluding colon in continuity and considered stable with regard to parenteral support (PS) need. Intestinal failure will be defined according to the recommendations of the American Society of Parenteral and Enteral Nutrition (ASPEN), i.e. a reduction of gut function below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous (IV) supplementation is required to maintain health and/or growth;

At least 6 months elapsed since last surgical bowel resection;

Disqualifiers

Body mass index (BMI) <17.5 or >30 kg/m2;

Presence of clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study;

Presence of confirmed active infection, temperatures >100°Farenheit, or symptoms of an upper respiratory infection

Patients with Radiological (Radiography and/or CT) signs of significant bowel dilatation or pseudo-obstruction;

Trial design

Design model

Single group

Treatments tested in this trial

  • Crofelemer Oral Product

    Drug

    Crofelemer powder for solution (50g and 100g) or Crofelemer Powder for Oral Solution (100 mg/mL or 30 mg/mL vials for reconstitution and oral dosing)

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Crofelemer GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ostomy output reduction

Change in ostomy output from baseline over the entire 12-week treatment period as average weekly ostomy output at week 12.

Time frame
12 weeks

Secondary outcomes

1

Change in average weekly Parenteral Support (PS) volume

Time frame
16 weeks from treatment start
2

Change in SBS-QoL (Short bowel syndrome quality of life)

Patient reported questionnaire with

Time frame
16 weeks from treatment start
3

Change in GSRS (Gastrointestinal Symptom Rating Scale)

Time frame
16 weeks from treatment start
4

Change in intestinal absorption of fluids and macronutrients with consequent reduction of macronutrient requirements in patients with SBS

Time frame
12 weeks after start or End of Trial

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lindsey Russell, MD

Lead sponsor

The Cleveland Clinic

Sponsor institution

Napo Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov
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