CFTR Related Pancreatitis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis CFTR Gene Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Evaporimeter TEWL probes, model RG-1

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Beta Adrenergic Sweat Test

Intervention Type COMBINATION_PRODUCT

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.

1. Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site.
2. Under the first probe, injection atropine will be given in one small area of the skin.
3. Under the second probe, first injection carbachol will be given in one small area of the skin.
4. Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine.
5. 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.

Interventions

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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.

1. Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site.
2. Under the first probe, injection atropine will be given in one small area of the skin.
3. Under the second probe, first injection carbachol will be given in one small area of the skin.
4. Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine.
5. 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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