Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea

NCT00572975 | Completed Phase 4 DMC

• 1 other identifier: 2004-5-3733
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Pancreatic Insufficiency

Keywords

New diagnostic test for Cystic Fibrosis.

Outcome Measures

Primary Outcomes (1)

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

  72 hours

Secondary Outcomes (3)

• 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.

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

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

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

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

  12-hour fast on two separate occasions

Study Arms (1)

1

EXPERIMENTAL

Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA)

Interventions

Pentadecanoic acid (PA) and Triheptadecanoin (THA) OTHER

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

1

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4399, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Interventions

pentadecanoic acid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Maria Mascarenhas, M.D.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: August 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 30, 2008

Record last verified: 2008-09

Locations

US (1)