NCT00429325

Brief Summary

Every year more than 4 billion cases of diarrhea occur worldwide culminating in about 2.5 million deaths, almost all in the developing nations. Reliable diagnosis of patients with acute infectious diarrhea which could be appropriately managed with antibiotics at presentation still remains a formidable challenge to the clinicians. To address this issue of predicting microbiological infectious etiology for diagnosing acute infectious diarrhea, we would evaluate stools from all patients with acute diarrhea with culture, Guaiac based fecal occult blood test (FOBT), Calprotectin and lactoferrin assays simultaneously. This would be the first study evaluating fecal calprotectin as a diagnostic marker in acute diarrhea

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
Last Updated

July 17, 2007

Status Verified

February 1, 2007

First QC Date

January 30, 2007

Last Update Submit

July 16, 2007

Conditions

Acute Diarrhea

Keywords

acute infectious diarrhea,fecal calprotectin,stool culture,hemoccult test,Guaiac fecal occult blood test (FOBT)fecal lactoferrin

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients having acute diarrhea i.e. 3 or more stools per day or stool weight exceeding 200 grams lasting less than 15 days

You may not qualify if:

  • Patients having the following diagnosis as they might have high calprotectin levels not only because of the diarrhea per se but may also be because of the underlying pathology itself.
  • Inflammatory bowel disease (Crohn's disease, ulcerative disease)
  • Gastrointestinal malignancy (colorectal cancer, gastric cancer etc)
  • Cirrhosis of liver
  • Chronic pancreatitis
  • Currently on non steroidal anti inflammatory therapy
  • Younger than 1 year of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory Walther, Weindel & Colleagues

Frankfurt am Main, Hesse, D 60437, Germany

Location

Department of Medicine I, Division of Gastroenterology and Clinical Nutrition, Johann Wolfgang Goethe-University Hospital

Frankfurt am Main, Hesse, D-60590, Germany

Location

Study Officials

  • Jürgen M Stein, MD,PhD

    JW Goethe University Hospital, Frankfurt

    STUDY DIRECTOR

  • Yogesh M Shastri, MD, DNB

    JW Goethe University Hospital, Frankfurt

    PRINCIPAL INVESTIGATOR

  • Wolfgang F Caspary, MD

    JW Goethe University Hospital, Frankfurt

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

January 1, 2004

Study Completion

January 1, 2007

Last Updated

July 17, 2007

Record last verified: 2007-02

Locations

DE(2)