CFTR Related Pancreatitis Study

Assessing CFTR Function in Patients With CFTR Related Pancreatitis Using a Novel Sweat Test

The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Since not every CFTR gene mutations clinically manifest, just identifying these CFTR gene mutations may not help to establish a clear role of this defect in the etiology of the individual ARP/CP. The novel beta-adrenergic sweat secretion test is a very sensitive test to detect small abnormalities in CFTR function in form of a linear gene-function relation. By identifying even mild CFTR defects, in future will help in finding the role of CFTR modulators and providing treatment to these patients.

Study Overview

• Status: Withdrawn
• Conditions: Cystic Fibrosis; CFTR Gene Dysfunction
• Intervention / Treatment: Combination product: Beta Adrenergic Sweat Test

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age : 4 years and older
• Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis

• History: at least one of the following:

  1. Carry one or two CFTR mutations
  2. Borderline sweat chloride levels
  3. Has Family History of CF

  4. Has had positive CF Newborn screening

     Exclusion Criteria:

• Pregnant females: will be excluded at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Interventional Arm; All patients consented to study will undergo study intervention which is Beta-adrenergic sweat test (Beta sweat test) using evaporimeter. It takes about 60 minutes to complete this test. Once this test is completed, patient will be considered to have completed the study.

Combination product: Beta Adrenergic Sweat Test; In Beta Sweat Test - sweat secretion will be stimulated by injecting a series of drugs within the skin surface. Small needles will be used to inject minute amounts of each drug. Before and after each skin injection, the skin will be cleaned using an alcohol swab.; Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site.; Under the first probe, injection atropine will be given in one small area of the skin.; Under the second probe, first injection carbachol will be given in one small area of the skin.; Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine.; Lastly, beta-adrenergic sweating will be stimulated by injecting a combination of the following drugs: atropine, isoproterenol, and aminophylline (β-cocktail). Using probes, all sweat rate readings will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test	CFTR function assessment of patients with acute recurrent or chronic pancreatitis by using Beta adrenergic sweat test.	60 mins

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: The National Pancreas Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ACTUAL): February 1, 2021
• Study Completion (ACTUAL): February 1, 2021

Study Registration Dates

• First Submitted: February 16, 2020
• First Submitted That Met QC Criteria: February 16, 2020
• First Posted (ACTUAL): February 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Pancreatitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents
• Other Study ID Numbers: 1000065960

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No