THE AMERICAN JOURNAL OF GASTROENTEROLOGY
6, 2003
© 2003 by Am. Coll. of Gastroenterology
Published by Elsevier Inc.
Fecal Lactoferrin Is a Sensitive and Specific Marker
in Identifying Intestinal Inflammation
Sunanda V. Kane, MD, MS PH, William J. Sandborn, MD, Paul A. Rufo, MD, Anna Zholudev, MS,
James Boone, MS, David Lyerly, PhD, Michael Camilleri, MD, and Stephen B. Hanauer, MD
University of Chicago, Chicago, Illinois; Mayo Clinic, Rochester, Minnesota; Children’s Hospital, Boston
Massachusetts; and TechLab, Blacksburg, Virginia
OBJECTIVE: Lactoferrin is a glycoprotein expressed by ac-
tivated neutrophils. The aim of this study was to determine
the sensitivity and specificity of fecal lactoferrin concentra-
tions for inflammatory bowel disease (IBD) or irritable
bowel syndrome (IBS) versus healthy controls.
METHODS: Fresh stool samples were collected from outpa-
tients with ulcerative colitis (UC), Crohn’s disease (CD), or
IBS. Clinical disease activity for IBD was assessed using a
modified Harvey–Bradshaw Activity Index. Fecal lactofer-
rin concentrations were determined using a polyclonal an-
tibody-based enzyme linked immunoassay. Mean fecal lac-
toferrin concentrations for each group and sensitivity and
specificity of the assay were determined.
RESULTS: One hundred-four CD patients, 80 UC patients,
31 IBS patients, and 56 healthy controls were recruited. The
mean ⫾ SE fecal lactoferrin concentration (␮g/g fecal
weight) was 440 ⫾ 128 for CD patients, 1125 ⫾ 498 for UC
patients, 1.27 ⫾ 0.29 for IBS patients, and 1.45 ⫾ 0.4 for
healthy controls. Fecal lactoferrin was 90% specific for
identifying inflammation in patients with active IBD. Ele-
vated fecal lactoferrin was 100% specific in ruling out IBS.
CONCLUSIONS: Fecal lactoferrin is sensitive and specific for
detecting inflammation in chronic IBD. This noninvasive
test may prove useful in screening for inflammation in
patients presenting with abdominal pain and diarrhea. (Am J
Gastroenterol 2003;98:1309 –1314. © 2003 by Am. Coll. of
Gastroenterology)
INTRODUCTION
Inflammatory bowel disease (IBD) and initable bowel syn-
drome (IBS) are two chronic conditions that can present
with similar symptoms such as diarrhea and abdominal pain,
but have very different underlying pathophysiology. IBD is
a chronic, idiopathic inflammatory condition affecting vary-
ing layers of the GI tract. The anatomic location and degree
of the inflammation determines the predominant symptoms
that may include rectal bleeding, diarrhea, and abdominal
pain. In contrast, IBS is a functional noninflammatory dis-
order, which can present with abdominal pain and diarrhea.
This syndrome is thought to be caused by abnormal GI
Vol. 98, No.
ISSN 0002-9270/03/$30.00
doi:10.1016/S0002-9270(03)00232-6
motility or altered pain perception. Clinically, it can be
difficult to differentiate between the two conditions in the
absence of rectal bleeding and systemic illness. The diag-
nosis of IBD requires invasive testing to determine the
anatomic location of inflammation and for procurement of
tissue samples. A noninvasive diagnostic test to screen
patients for GI inflammation as a cause for diarrhea would
have clinical utility. Though ultrasonography and autolo-
gous leukocyte imaging have been previously used as non-
invasive tests, they are expensive, require special expertise,
and equipment and are not widely used in clinical practice.
Lactoferrin, an iron-binding glycoprotein, is secreted by
most mucosal membranes and is a major component of the
secondary granules of polymorphonuclear neutrophils, a
primary component of the acute inflammatory response (1,
2). Other hematopoietic cells such as monocytes and lym-
phocytes do not contain lactoferrin (3). During intestinal
inflammation, leukocytes infiltrate the mucosa, resulting in
an increase in the concentration of lactoferrin in the feces
(4). The protein is resistant to proteolysis and unaffected by
multiple freeze thaws, providing a useful marker in feces as
an indicator of intestinal inflammation. The LEUKO-TEST,
developed by TechLab (Blacksburg, VA), is a latex agglu-
tination test that detects fecal lactoferrin as a marker of
leukocytes or transudation of lactoferrin through an in-
flamed or ulcerated mucosa. Latex agglutination has been
found to be sensitive as a qualitative assay for lactoferrin in
patients with infectious colitis (5).
The primary aim of this study was to evaluate the clinical
utility of an ELISA assay, which measures the concentration
of lactoferrin in feces to detect active GI inflammation in
patients with IBD as compared with the noninflammatory
condition, IBS. A secondary aim of the study was to deter-
mine if fecal lactoferrin concentrations correlated with dis-
ease activity in patients with IBD.
MATERIALS AND METHODS
Patients
Patients with a history of Crohn’s disease (CD), ulcerative
colitis (UC), or IBS were recruited from three tertiary re-
ferral practices. Two of the centers recruited adult patients
(University of Chicago, Mayo Clinic), and one center re-
1310 Kane et al.
cruited pediatric patients (Children’s Hospital, Harvard
Medical School). Diagnosis of the patients was based on a
combination of clinical, radiographic, endoscopic, and his-
tological criteria, as appropriate (6, 7). Patients with both
active and inactive IBD were asked to participate. Patients
of all ages were included. Exclusion criteria included: 1) a
history of HIV and/or hepatitis B or C infection, 2) a history
of infectious diarrhea within the previous 6 months, or 3)
presence of a colostomy or ileostomy. Pregnancy was not an
exclusionary factor, although no recruited patients were
known to be pregnant at the time of participation.
Protocol
Patients were recruited either by their treating physician or
by written advertisement. Each patient was paid $25 for
participation in the study. The study was approved by the
Institutional Review Board at each center, and all patients
gave written informed consent.
Each patient was evaluated by one of the investigators or
their study personnel to determine their disease activity. For
patients with IBD, a modification of the Harvey–Bradshaw
Activity Index was used (8) (Appendix A). For patients with
a prior diagnosis of IBS, a symptom questionnaire adapted
from a previous publication (9) was used to document the
severity of functional GI disease symptoms (including those
referable to the upper GI tract) at the time of stool sampling
(Appendix B). Disease activity for IBD patients was arbi-
trarily defined as a score of 4 or higher. A score of ⱖ15 or
higher defined active symptoms for patients with IBS.
Quantitative Stool Analysis
The patients supplied fresh fecal samples containing a min-
imum of 30 ml. The sample was labeled, sealed, and stored
at ⫺20°C until shipment to a central laboratory for assay. For
the quantitative assay (which expresses data continuously),
fecal specimens were serially diluted 10-fold and analyzed by
a polyclonal antibody-based ELISA (TechLab) using wells
containing immobilized polyclonal antibodies to human lacto-
ferrin. In this assay, lactoferrin, if present, binds to the anti-
bodies during a 30-min incubation at 37°C. After the incuba-
tion, polyclonal antibodies coupled to horseradish peroxidase
enzyme (conjugate) were added and allowed to bind to cap-
tured lactoferrin during a second 30-min incubation. Unbound
conjugate was then washed from the well, and one component
substrate (tetra-methyl-benzidene and hydrogen peroxide) was
added for color development. After the 15-min substrate incu-
bation, a 0.6-N sulfuric acid solution was added to quench the
reaction, and the absorbance of each assay well was measured
spectrophotometrically at 450 nm (A450). Fecal lactoferrin con-
centrations were determined by comparison with a standard
curve generated using purified human lactoferrin and analyzed
by linear regression using the log–log method.
The lowest dilution of specimen giving a reading for
absorbance at 450 nm within the linear portion of the curve
was used to determine the lactoferrin concentration. The
final concentration was obtained by multiplying the concen-
tration by the dilution factor.
AJG – Vol. 98, No. 6, 2003
Results are reported as ␮g/g wet weight of feces. For this
study, the laboratory technicians performing the analyses
were blinded to the patient diagnosis and the study hypoth-
esis. The results from 56 previously tested healthy subjects
were used as a control group.
Qualitative (Positive or Negative) Stool Analysis
A total of 180 patient specimens from the original 215
patient cohort were tested using the qualitative ELISA.
These specimens included all 31 IBS patients and 149
randomly chosen IBD patients. In addition, all 56 healthy
controls were included for a total of 236 fecal specimens.
The ELISA procedure described above for the quantitative
analysis was done using the following modifications. A
single specimen dilution of 1:400 and A450 cutoff of 0.200,
previously optimized for the detection of fecal leukocytes,
were used. This corresponds to a concentration of 12.8 ␮g/g
feces. These results were reported as positive (A450 ⱖ 0.200)
or negative (A450 ⬍ 0.200) for a “yes/no” indicating the pres-
ence of intestinal inflammation. A positive control consisting
of diluted human lactoferrin and a negative control consisting
of test diluent were evaluated with each ELISA analysis to
facilitate comparisons of results between assay days.
Statistical Analysis of Results
Standard curves for 56 normal healthy volunteers were
provided by TechLab before this study to establish the
normal range of fecal lactoferrin in healthy individuals.
Mean fecal lactoferrin concentrations for each diagnostic
category were determined and compared with those of
healthy controls. Stratification by disease activity was done
to compare fecal lactoferrin concentrations in patients with
active IBD with those in patients with inactive IBD. Sensi-
tivity and specificity of the assay were calculated using a
level of 4 ␮g/g fecal weight as the cutoff for normal.
Differences were tested for statistical significance using a
two-tailed t test. Multivariate logistic regression was per-
formed to build models to best predict lactoferrin results,
and Kendall–Tau correlation calculations were performed
between the lactoferrin concentrations and disease activity
index using the quantitative assay. A p value of ⬍0.05 was
used to define statistical significance.
Qualitative (positive/negative) results were analyzed for
149 of the IBD patients and all 31 IBS patients to calculate
sensitivity, specificity, positive predictive value, negative
predictive value, and overall correlation.
RESULTS
A total of 215 patients were enrolled between March, 2000
and February, 2001. One hundred-four had CD, 80 had UC,
and 31 had IBS. Table 1 shows the clinical characteristics of
the patients. The median age was 39 yr with 15% of the
subjects under the age of 18 yr.
The mean (⫾SE) lactoferrin concentration was 1125 ⫾
498 ␮g/g in patients with UC, 440 ⫾ 128 ␮g/g in patients
AJG – June, 2003
Table 1. Patient Characteristics
n 80
Median age (yr) (range)
Sex (m/f)
Lactoferrin concentration mean units (⫾SE)
Disease activity score* median (range)
* Harvey–Bradshaw Activity Index for UC and CD; Mathias score for IBS.
with CD, 1.27 ⫾ 0.29 ␮g/g in patients with IBS, and 1.45
⫾ 0.40 ␮g/g in healthy controls (Fig. 1).
Fecal lactoferrin concentrations for patients with IBD
were significantly elevated compared with those of healthy
controls (p ⫽ 0.02). Because there was no difference in
lactoferrin levels between the healthy controls and the IBS
patients (p ⫽ 0.81), data from these two groups were com-
bined in subsequent analyses.
The mean fecal lactoferrin concentration was signifi-
cantly higher in patients with UC compared with patients
with CD (p ⫽ 0.04). Analysis for IBD patients based on
disease location (small bowel, small bowel ⫹ large bowel,
large bowel), gender, age, or institution failed to reveal any
significant differences between groups (p ⬎ 0.20 for all
analyses, data not shown).
Among the patients with either UC or CD, stratification
by disease activity (active vs inactive) demonstrated signif-
icant differences in fecal lactoferrin concentrations (Fig. 2).
In patients with CD, the mean concentration was 550 ⫾
174 ␮g/g in patients with active disease and 204 ⫾ 67 ␮g/g
for inactive disease (p ⬍ 0.001) (Fig. 3). In UC, the mean
concentration was 2020 ⫾ 1076 ␮g/g in patients with active
disease, and 136 ⫾ 41 ␮g/g in patients with inactive disease
(p ⬍ 0.001). Even with inactive disease, patients with IBD
still had significantly higher lactoferrin concentrations than
healthy controls or patients with IBS (p ⫽ 0.02). The Ken-
dall–Tau correlation coefficient between disease activity
Figure 1. Mean fecal lactoferrin concentrations among different groups.
Fecal Lactoferrin and Intestinal Inflammation 1311
UC CD IBS
104 31
36 (10–71) 38 (11–78) 49 (19–78)
37/43 56/47 6/25
1125 ⫾ 498 440 ⫾ 128 1.27 ⫾ 0.29
5 (0–22) 6 (0–24) 22 (7–36)
level and lactoferrin concentration for CD was 0.66 (p ⬍
0.001) and for UC was 0.61 (p ⬍ 001). For any diagnosis of
IBD, the correlation coefficient was 0.64 (p ⬍ 0.001).
The sensitivity of the quantitative fecal lactoferrin assay
for IBD was 78% (95% CI ⫽ 69 – 83%), and the specificity
was 90% (95% CI ⫽ 83–96%). Based on these tests char-
acteristics, the likelihood ratio for a positive test was 7.8.
Using the quantitative lactoferrin results determined in
the test and baseline concentrations determined for the con-
trol population, a second qualitative ELISA that used a
single 1:400 dilution specimen for fecal lactoferrin was
established. The test was subsequently used to screen a total
of 236 fecal specimens from IBD and IBS patients and
healthy persons. The results are shown in Table 2. Of the 92
specimens from active IBD patients, 86% were positive in
the qualitative ELISA and 14% were negative. Of those with
active CD, 85% were positive and 15% were negative. In the
patient population with active UC, 88% were positive and
12% were negative. None of the 31 patients with IBS or 56
of the healthy controls were positive; all were negative at
this dilution. The sensitivity and specificity of the qualitative
ELISA for distinguishing active IBD from IBS and healthy
controls were 86% and 100%, respectively. The positive
predictive value and negative predictive value were
100% and 87%, respectively, with a correlation of 93%
(Table 3).
1312 Kane et al. AJG – Vol. 98, No. 6, 2003

Figure 2. Mean fecal lactoferrin concentration between inactive and active disease in IBD.

DISCUSSION toferrin concentrations in IBS patients and healthy controls

In this study, we used two ELISAs for the determination of
fecal lactoferrin in patients with IBD and IBS and in healthy
persons. The quantitative ELISA was used to establish fecal
lactoferrin concentrations in patients with active and inac-
tive IBD, and to compare these results with those observed
in persons with IBS and in healthy persons. Our results
show that fecal lactoferrin concentrations were significantly
higher in patients with active and inactive IBD than in IBS
or healthy controls. In addition, we showed that fecal lac-
were virtually identical.
These quantitative results were subsequently used to es-
tablish baseline concentrations for a simpler ELISA format
using single diluted specimen to determine the presence of
elevated fecal lactoferrin. Our results showed that in both
formats, fecal lactoferrin serves as a sensitive and specific
marker for detecting chronic inflammation. Both ELISAs
demonstrated that fecal lactoferrin concentrations were sig-
nificantly higher in patients with IBD than in patients with

Figure 3. Receiver operator characteristic curve for fecal lactoferrin and presence of inflammation.
AJG – June, 2003 Fecal Lactoferrin and Intestinal Inflammation 1313

Table 2. Summary of Qualitative ELISA Positivity Rates

Qualitative Qualitative
Total Assessments (n ⫽ 236) Total ELISA Positive ELISA Negative
Total IBD (CD and UC) 149 74.5% (111) 25.5% (38)
Active 92 85.9% (79) 14.1% (13)
Inactive 57 56.1% (32) 43.9% (25)
Total CD 78 76.9% (60) 23.1% (18)
Active 52 84.6% (44) 15.4% (8)
Inactive 26 61.5% (16) 38.5% (10)
Total UC 71 71.8% (51) 28.2% (20)
Active 40 87.5% (35) 12.5% (5)
Inactive 31 51.6% (16) 48.4% (15)
Total active IBS 31 0 100.0% (31)
Total healthy persons 56 0 100.0% (56)

IBS or in healthy controls. This finding was not dependent
on the disease activity of the patients with IBD (patients
with inactive IBD still had significant elevation of fecal
lactoferrin), although the sensitivity of the assay is better in
patients with active IBD compared with those with inactive
IBD (86% vs 56%).
Latex agglutination for antilactoferrin antibody has been
shown to be a sensitive test for the presence of leukocytes
(10, 11). More specifically, it has been shown to be a marker
for infectious colitis (5). Uchida et al. first showed the
clinical utility of fecal lactoferrin concentrations using
ELISA in IBD patients (12). Fecal lactoferrin concentrations
of 38 patients with active UC were 307.4 ⫾ 233.9 ␮g/g
feces and 191.7 ⫾ 231.1 ␮g/g feces in 36 patients with CD.
These values were significantly higher than those in 35
normal persons, who had fecal lactoferrin concentrations of
only 0.75 ⫾ 0.83 ␮g/g feces. In 1998, Fine et al. reported
the use of the latex agglutination test for screening patients
presenting with chronic diarrhea (13). They found that 12
patients with either UC or CD demonstrated elevated con-
centrations of fecal lactoferrin. Even though the test had not
been optimized for IBD, the authors concluded that the
detection of elevated concentrations of fecal lactoferrin of-
fers an effective indicator of fecal leukocytes in patients
with chronic inflammatory diarrhea.
The mean lactoferrin concentrations reported in our study
are significantly higher for UC and CD than described
previously (12, 13). The reason for this discrepancy may be
Table 3. Statistical Evaluation Using the Qualitative ELISA Test to
Distinguish Active IBD From IBS and Healthy Controls
Active IBS and Healthy
(n ⫽ 179) IBD Persons
ELISA test positive 79 0 then it “rules in” the presence of intestinal inflammation
ELISA test 13 87
negative
Sensitivity (%) 85.9
Specificity (%) 100
Predictive positive 100
value (%)
Predictive negative 87.0
value (%)
Correlation (%) 92.7
based on different methodology. Thus, in the present study,
we serially diluted the fecal specimen to obtain the highest
dilution factor with detectable levels of lactoferrin for an
absolute quantification. Using this approach, a definite con-
centration of lactoferrin can be determined and result in a
broader range of concentrations in patients with IBD.
Multiple sources of lactoferrin in the bowel, including the
neutrophil and leakage of plasma through an inflamed mu-
cosa, are likely reasons for these observed differences. We
observed lower lactoferrin levels in CD patients than in UC
patients. Possible explanations for significant differences in
concentrations of fecal lactoferrin include the combination
of various sources of lactoferrin, ratios between monocytes
and neutrophils, and the extent of disease within the large
intestine. Because of the heterogeneous nature of the CD
patients in this study, we were unable to adequately clarify
to what degree the amount of ileal versus colonic disease
accounted for these differences. Further studies are under-
way to evaluate fecal lactoferrin levels in patients with CD
limited to the colon along with UC patients, as suggested
previously (14).
One of the strengths of this study was the use of another
disease comparison group. Patients with IBD had signifi-
cantly higher concentrations than those with IBS, regardless
of disease activity. The comparison with another control
group makes these results potentially useful in a clinical
setting. However, some caution must be used when inter-
preting “disease activity” for patients with UC. We used a
modified Harvey–Bradshaw Activity Index to define disease
activity, and to date this clinical index has not been vali-
dated in multiple populations.
The high specificity of fecal lactoferrin is particularly
beneficial; if a patient has an elevated fecal lactoferrin level,
with a high degree of certainty. This is useful in the eval-
uation of patients with chronic abdominal pain and diarrhea.
Using a noninvasive test such as this could help identify
those patients who need further testing, a definite diagnosis
by biopsy and anti-inflammatory drug therapy.
Patients who present with abdominal pain, cramping, and
a change in bowel habits comprise a major proportion of
visits to a gastroenterologist. Deciding which patients
1314 Kane et al. AJG – Vol. 98, No. 6, 2003

should undergo diagnostic tests is left to the discretion of the
individual physician. One recent study suggested that it is
not cost-effective to include colonoscopy in the workup of
patients suspected of having IBS (15). Only direct compar-
ison studies between diagnostic modalities will determine if
one is superior, or if a panel of diagnostic studies done in
series would be the most clinically useful.
Additional prospective studies are needed to assess the
clinical utility of detecting elevated fecal lactoferrin con-
centrations in patients with acute and chronic diarrhea.
Meanwhile, based on these and prior studies, fecal lactofer-
rin has been approved by the Food and Drug Administration
as a screening tool for detecting the presence of inflamma-
tion. Other future areas of research include the quantifica-
tion of fecal lactoferrin in other inflammatory colitides (mi-
croscopic colitis, collagenous colitis, diverticulitis,
pouchitis), intraindividual variation, the responsiveness of
fecal lactoferrin concentrations to change after treatment,
and the predictive value of rising fecal lactoferrin concen-
trations for clinical relapse.
ACKNOWLEDGMENTS
We are grateful to Virginia Polytechnic Institute and State
University, Department of Statistics, for providing an inde-
pendent data analysis.
Reprint requests and correspondence: Sunanda Kane, M.D.,
M.S.P.H., Assistant Professor of Medicine, University of Chicago,
5841 South Maryland Avenue, MC 4076, Chicago IL 60637.
Received June 19, 2002; accepted Oct. 30, 2002.
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tection of human lactoferrin in feces as a new marker for
inflammatory gastrointestinal disorders and colon cancer. Clin
Biochem 1994;27:259 –64.
13. Fine KD, Ogunji F, George J, et al. Utility of a rapid fecal latex
agglutination test detecting the neutrophil protein, lactoferrin,
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APPENDIX A
Harvey–Bradshaw Activity Index for CD
1) No. liquid or very soft stools per day:
2) Abdominal pain, sum of seven daily ratings:
(0 ⫽ none, 1 ⫽ mild, 2 ⫽ moderate, 3 ⫽ severe)
3) General well-being:
(0 ⫽ very well, 1 ⫽ slightly below par, 2 ⫽ poor, 3 ⫽ very
poor, 4 ⫽ terrible)
4) Complications: (score 1 point per item)
Arthritis or arthralgia
Skin or mouth lesions
Iritis or uveitis
Anal fissure, fistula, or perianal abscess
5) Abdominal mass:
(0 ⫽ none, 1 ⫽ questionable, 2 ⫽ definite, 3 ⫽ definite and
tender on examination)
Score: Patient Initials:

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