Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Stanford University

Status: Completed

Conditions: Healthy Adults

Treatments: Other: Thermosensitive gel rectal formulation; Other: Saline enema

Study type: Interventional

Funder types: Other

Identifiers

NCT02290665

IRB-29620

Details and patient eligibility

About

The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy
• Age 18 to 70 years old
• Non-pregnant

Exclusion criteria

• GI complaints
• Pregnancy
• Patients with previous colonic surgery or current bowel injury or obstruction
• Allergies to contrast

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups

Thermosensitive gel formulation

Experimental group

Description:

Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.

Treatment:

Other: Saline enema

Other: Thermosensitive gel rectal formulation

Saline enema

Experimental group

Description:

Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.

Treatment:

Other: Saline enema

Other: Thermosensitive gel rectal formulation