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Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea (MBT)

Primary Purpose

Cystic Fibrosis, Pancreatic Insufficiency

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pentadecanoic acid (PA) and Triheptadecanoin (THA)

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring New diagnostic test for Cystic Fibrosis.

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects with cystic fibrosis and pancreatic insufficiency (n=9), 8 years of age or older, in usual state of good health will be eligible to participate in this Aim.
Subjects will be screened for genotype and a history of pancreatic insufficiency (PI). PI will be confirmed by measurement of fecal elastase 1< 200 mg/g stool.

Exclusion Criteria:

Subjects will be ineligible if they have an FEV1 % predicted of < 40%, a history of fibrosing colonopathy or any significant bowel resection (>10 cm) with the exception of a routine, uncomplicated appendectomy.
Subjects with diabetes mellitus or disorders associated with altered energy metabolism (i.e. hypothyroidism), or any major illnesses that affect the gastrointestinal tract, will not be eligible for the study.
Subjects with significant liver disease, or significant developmental delay will also be excluded.
Subjects will be excluded if they have a food allergy related to any components of the experimental shake (i.e., soy or chocolate) or the stool marker, carmine red.
Subjects who are pregnant are not eligible. Subjects with a history of intolerance or allergy to Creon 20 will be excluded from the study.

Sites / Locations

The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Aim 1:Comparing Gastric Emptying and Small Bowel Transit Protocol in Healthy Controls

Secondary Outcome Measures

Aim 2:The results will establish which pattern of timing of enzyme ingestion results in optimal fat absorption of PA and HA. The results will also elucidate the role of gastric emptying and small bowel transit in subjects in CF.

Aim 3: The results will establish the reproducibility of MBT as well as estimate the fecal loss of odd chain fatty acids (PA & THA)

Aim 4: Dosage Titration Protocol is being tested in order to see changes in absorption with MBT

Full Information

NCT ID

NCT00572975

First Posted

December 11, 2007

Last Updated

September 26, 2008

Sponsor

Children's Hospital of Philadelphia

Collaborators

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00572975

Brief Title

Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea

Acronym

MBT

Official Title

MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

*The purpose of this study is to develop a more accurate, reliable, specific and more acceptable alternative clinical test to the 72-hour stool and diet collection for quantifying fat malabsorption in people with CF and pancreatic insufficiency.

Detailed Description

Nine subjects with CF will be recruited to complete the MBT on two separate occasions, with different doses of pancreatic enzymes At each MBT visit, subjects will receive a specific enzyme dose just before they drink the test meal (shake) Fat absorption is maximized when the enzymes are taken with the shake. If subjects usually receive brands of pancreatic enzymes different from Creon, their dose will be converted to an equivalent dose of Creon 20 for the study. Prior to each study visit all subjects will be required to: Eat their usual diet for 2 days prior to MBT Refrain from consuming alcohol or dairy products for 24 hours prior to MBT Refrain from non-routine physical exercise for 20 hours prior to MBT Adhere to a 12-hour fast prior to MBT (from 8 PM previous night) Can drink water from 8:00 PM on the night before the test to 2:00 AM on the day of the test At visits 1 and 2, blood samples will be obtained at hourly intervals over a period of eight hours. Samples will be analyzed for PA, HA and Triglyceride concentrations. Patients will be permitted to ingest non-caloric and non-caffeinated beverages. At hour 6, patients will be provided 1000 Kcal, low fat (12 grams of fat) lunch meal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Pancreatic Insufficiency

Keywords

New diagnostic test for Cystic Fibrosis.

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Pentadecanoic acid (PA) and Triheptadecanoin (THA)

Intervention Description

Two fats (Pentadecanoic acid and Triheptadecanoin) are administered in a breakfast shake for the purposes of determining malabsorption. in breakfast shake x1

Primary Outcome Measure Information:

Title

Aim 1:Comparing Gastric Emptying and Small Bowel Transit Protocol in Healthy Controls

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Time Frame

12-hour fast on 4 separate occasions, each at least 5 days apart

Title

Aim 3: The results will establish the reproducibility of MBT as well as estimate the fecal loss of odd chain fatty acids (PA & THA)

Time Frame

12-hour fast on three separate occasions, each at least 5 days apart

Title

Aim 4: Dosage Titration Protocol is being tested in order to see changes in absorption with MBT

Time Frame

12-hour fast on two separate occasions

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with cystic fibrosis and pancreatic insufficiency (n=9), 8 years of age or older, in usual state of good health will be eligible to participate in this Aim. Subjects will be screened for genotype and a history of pancreatic insufficiency (PI). PI will be confirmed by measurement of fecal elastase 1< 200 mg/g stool. Exclusion Criteria: Subjects will be ineligible if they have an FEV1 % predicted of < 40%, a history of fibrosing colonopathy or any significant bowel resection (>10 cm) with the exception of a routine, uncomplicated appendectomy. Subjects with diabetes mellitus or disorders associated with altered energy metabolism (i.e. hypothyroidism), or any major illnesses that affect the gastrointestinal tract, will not be eligible for the study. Subjects with significant liver disease, or significant developmental delay will also be excluded. Subjects will be excluded if they have a food allergy related to any components of the experimental shake (i.e., soy or chocolate) or the stool marker, carmine red. Subjects who are pregnant are not eligible. Subjects with a history of intolerance or allergy to Creon 20 will be excluded from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Mascarenhas, M.D.

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104-4399

Country

United States

12. IPD Sharing Statement

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Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea

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