S96 Abstracts
p<0.05). A total of 237 patients had reported diarrhea and 42 patients had Disclosure: Dr. Jeppesen - Consultant: NPS Pharmaceuticals, Consultant:
reported constipation. Nevertheless, positivity time on the D-Xylose BT did
not correlate with symptoms of diarrhea or constipation.
Conclusion: This study demonstrates that delayed gastric emptying correlates
significantly with D-Xylose BT positivity at 180 minutes. Therefore, findings
on the D-Xylose BT over the 180-minute period could warrant further inves-
tigations for an underlying motility disorder such as gastroparesis or even
small bowel dysmotility. Therefore, performing the D-Xylose BT over a full
180-minute period of time is paramount. Interestingly, neither diarrhea nor
constipation affects the pattern of D-Xylose breath test results. (NIH Grant UF
CTSI 1UL1RR029890).
243
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The Fluid Composite Effect (FCE): A Clinically Important Surrogate
Measure of Intestinal Absorption in Adult Subjects with Short Bowel
Syndrome (SBS)-Intestinal Failure (IF) Dependent on Parenteral Support
(PS) Being Treated with Teduglutide
Palle Jeppesen, MD, Dr. Sci, PhD,1 Marek Pertkiewicz, MD, PhD,2 Kenneth
Fujioka, MD,3 Joseph Boullata, PharmD, RPh, BCNSP,4 Peter Berghoefer, PhD,5
Bo Joelsson, MD, PhD6. 1. Rigshospitalet, Copenhagen, Denmark; 2. Medical
University of Warsaw, Warsaw, Poland; 3. Scripps Clinic, San Diego, CA;
4. University of Pennsylvania, Pennsylvania, PA; 5. Nycomed GmbH, Konstanz,
Germany; 6. NPS Pharmaceuticals, Bedminster, NJ.
Purpose: Teduglutide has been suggested to improve intestinal fluid absorp-
tion in SBS-IF subjects. This study describes the effects of teduglutide when
individual components such as parenteral volume, urine volume, and oral fluid
intake are utilized to comprehensively characterize the effect of teduglutide on
intestinal fluid absorption.
Methods: The FCE has been defined as Parenteral Volume + Oral Fluid Vol-
ume ¬- Urine Volume. This was calculated in study CL0600-020 after an initial
optimization and stabilization period occurred to establish a stable baseline
urine volume, a surrogate marker for intestinal fluid absorption. FCE was cal-
culated to compare teduglutide 0.05 mg/kg/d subcutaneously (SC) vs placebo,
as well as PS volume alone.
Results: At week 24 in study CL0600-020, FCE changes were respectively -5.4
L/wk with teduglutide (n=39) and -1.1 L/wk with placebo (n=39) compared to
-2.3 L/wk with placebo and -4.4 L/wk with teduglutide using just reduction in
PS volume. The FCE and PS volume reduction, which characterize the effects
of teduglutide, are shown from weeks 4 to 24 in Figure 1.
Conclusion: In a well-controlled trial of adult SBS-IF subjects utilizing the
FCE as a measure of direct intestinal absorption, teduglutide is shown to sig-
nificantly improve absorption when compared with placebo. Calculating the
FCE by combining these 3 easily measurable clinical parameters provides a
more comprehensive measurement than measuring PS reduction only. The
FCE may reflect the true effect of the novel GLP-2 analog, teduglutide, and
allow more appropriate monitoring by practitioners who manage complex
SBS-IF patients.
The American Journal of Gastroenterology
Nycomed GmbH Dr. Pertkiewicz - Consultant: NPS Pharmaceuticals, Member of
Advisory Board: Nutricia Scientific Foundation, Lectures at Teaching Workshops
Dr. Fujioka: No financial relationships to report Dr. Boullata - PI: NPS Pharma-
ceuticals Dr. Berghoefer - Employee: Nycomed GmbH Dr. Joelsson - Employee:
NPS Pharmaceuticals.
244
New Onset Heartburn as a Gastrointestinal Symptom of Severe Malaria
Lazarus Mutinda, MD,2 Daniella Gichuru, MD,2 Eunice Siria, MD,2
Moses Lumarai, MD,2 Gabriel Lee, MD,1 Simon Maina, MD2. 1. Gastroenterology,
University of Texas Medical Branch, Galveston, TX; 2. Maua Methodist
Hospital, Maua, Kenya.
Purpose: Malaria represents a special challenge because its clinical presenta-
tion is well recognized to be non-specific and may include nausea, vomiting,
abdominal pain, anorexia and diarrhea. It is unknown whether heartburn is an
associated symptom. The purpose of this study was to determine the incidence
of heartburn and other gastrointestinal symptoms in patients presenting with
severe malaria infection at a community Kenyan hospital.
Methods: We performed a retrospective analysis of hospitalizations and dis-
charges with severe malaria at Maua Methodist Hospital in Maua, Kenya
from June 1st thru 10th, 2011. Adult patients were identified and consent was
obtained for a detailed interview on discharge. Severe malaria was defined as
a positive blood smear showing malaria trophozoites requiring inpatient IV
quinine therapy. Patients that met criteria and consented to the interview were
asked questions regarding gastrointestinal symptoms. Complaints of anorexia,
nausea, vomiting, abdominal pain, diarrhea and heartburn were recorded
based on recollection of symptoms prior to admission, upon presentation
and on discharge. Heartburn (KIUNGULIA in Kiswahili) was defined as a
retrosternal burning discomfort, non-lateralizing, worsened by lying down
with a hyperacidity sensation.
Results: 8 patients were identified with severe malaria that consented to an
interview. The median age was 28 years. No patients reported gastrointestinal
symptoms prior to the illness. On admission, reported symptoms in decreas-
ing order of occurrence were vomiting (7), abdominal pain (6), nausea (5),
heartburn (4), anorexia (2) and diarrhea (2). On discharge, only one com-
plaint of abdominal pain was reported and all other gastrointestinal symptoms
were resolved.
Conclusion: This was a study with limitations aimed at assessing the inci-
dence of heartburn and other gastrointestinal symptoms in patients with no
prior complaints diagnosed with severe malaria. Vomiting, abdominal pain
and nausea were common as previously described in the traditional literature.
The vast majority of symptoms resolved with malaria treatment. New onset
of heartburn was reported to occur in half of patients with severe malaria.
The etiology of this new reported complaint is unclear and merits further
research.
245
Total Intestinal Perfusion Study with Yoga (Shankh Prakshalana)
Vijaypal Arya, MD, FACP, AGAF, FACG,1 Kalpana Arya, MD,2 Swarn Arya,
BS,2 Jiten Patel, MS,2 Ashok Valluri, MD, MS (MPH)2. 1. Wyckoff Heights
Medical Center, Brooklyn, NY; 2. Vijaypal Arya Gastroenterology PC, Middle
Village, NY.
Purpose: Bolus lukewarm saline with yoga poses is an ancient method for
intestinal cleansing, described in yoga literature as “shankh prakhshalana,”
now standardized by our research team as “Shudh.” In our initial study - “Effi-
cacy of Bolus Lukewarm Saline and Yoga Postures as a Colonoscopy Prepara-
tion: A Pilot Study,” the bowel cleansing was completed in 101 minutes with
preparation quality better that was better than NuLytely. The major concern
of this type of colonoscopy preparation is the significant amount of sodium
intake during the process, on average 7.2 grams. To explore the electrolyte and
water absorption/secretion, we conducted this total intestinal perfusion study.
Volume 106 | supplement 2 | October 2011 www.amjgastro.com

Methods: Upon IRB approval, 10 healthy volunteers with no history of salt
sensitivity were enrolled. After overnight fast, the subjects presented to the
office suite to perform the study. Weight, vital signs and basic metabolic panel
were recorded before and after the study. Shudh solution was prepared by add-
ing 9 gm of sodium chloride in one liter of lukewarm water. Sulfabromoph-
thalein (BSP), 30 mg was added to the first 8 oz. of lukewarm salt water as an
indicator. The solution (8-16 oz.) was drunk in bolus form over a period of 1
to 2 minutes alternating with yoga poses. Rectal effluent was tested with a few
drops of sodium hydroxide and once the color had changed to purple, indi-
cating presence of BSP, the stool was collected and its volume was measured
until the last clear bowel movement. The solution intake was recorded. Stool
osmolality and electrolytes were measured.
Results: The average solution intake was 2 liters (1.5-2.5) with salt intake of
18 gm (13.5-22.5). The average time to complete the process was 75 min-
utes (57-114). Sodium absorption was 30.9% (2.29 gm) with a range of
3.5-60.6%. The net absorption of sodium and water was 1.31 mEq and 11.1
mL per minute, respectively. Pre and post serum electrolyte values didn’t
show any statistically significant change (except for chloride and potassium).
None of these were clinically signifacant. There was a slight trend towards
weight loss (0.22 lbs).
Conclusion: To our knowledge, this is the first perfusion study involving a
yogic process. We used the widely accepted balance (intake and output) tech-
nique. In their study published over 40 years ago, Love et al (1968) used an
isotonic solution with a continuous oral infusion rate of 100 mL per minute for
2-4 hrs with a net sodium and water absorption of 1.93 mEq and 14.3 mL per
minute, respectively. We speculate that the Yogic process enhanced parasym-
pathetic activity and bolus intake leads to less sodium and water absorption
due to faster transit and less time for ionic exchange.
Disclosure: Vijaypal Arya - President, Vikalp Inc. Kalpana Gupta - No financial
relationship Swarn Arya - No financial relationship Ashok Valluri - No financial
relationship Jiten Patel - No financial relationship.
246
Double-Balloon Enteroscopy for Retrieval of Retained Small-Bowel Video
Capsules - A Single Center Experience
Niket Sonpal, MD, Deepak Vadada, MD, Alexander Bershadskiy, MD, Antonio
Mendoza Ladd, MD, Matthew Grossman, MD, Mylan Satchi, MD, Gregory
Haber, MD, FRCP. Lenox Hill Hospital, Hauppauge, NY.
Purpose: Capsule endoscopy (CE) allows for visualization of mucosa and
is an important tool in the evaluation of occult GI bleeding, inflammatory
bowel disease (IBD), and other small bowel pathology. In certain cases,
such as stricturing Crohn’s disease, retention of the video capsule remains
a major concern and is the most significant complication associated with
capsule endoscopy. Surgery has been the primary method of capsule retrieval,
however, less invasive methods are favored with the increasing prevalence
of double balloon enteroscopy. This study attempted to investigate the inci-
dence of capsule retention at our center and the factors associated with those
findings.
Methods: A retrospective analysis of all video capsule studies was performed
at our center, with the aim of evaluating the role of DBE as the first method to
retrieve entrapped video capsules. Investigation of our endoscopy reporting
system found eight retained capsules in the last five years.
Results: The patients were found to be between the ages of 19-91 years of
age with an average age of 62.4 years of age. In terms of gender, the ratio
was found to be 50% male and 50% female. Of the 8 patients found to
have retained capsules, the most common indications were anemia (50%),
IBD (25%), Familal Adenomatous Polyposis (12.5%) and abdominal pain
(12.5%). The most common symptoms noted after the capsule retention were
obstructive symptoms with nausea, vomiting and abdominal in 50% (4/8)
and abdominal pain in 37.5% (3/8). One of the patients had no associated
symptoms for 7 years since the capsule study was done. The most common
means of diagnosing capsule retention was by abdominal x-ray (7/8 cases).
All of the patients had the capsules removed via DBE using Roth net bas-
kets for retrieval. None of the patients in this series required surgery and no
© 2011 by the American College of Gastroenterology
Abstracts S97
perforations occurred. The duration range for the procedures ranged from
90 minutes to 210 minutes.
Conclusion: DBE is a reliable method for removing retained capsules and
might prevent unnecessary surgery. Although the most common symptoms
were nausea and vomiting, we did have the first case of a patient without
any symptoms for seven years since the capsule study. Of interest, one of the
patients had two capsules stuck within the same colonic diverticulum. When
surgery is required, preoperative capsule retrieval allows preoperative diagno-
sis, adequate staging in case of malignancy, and optimal surgical planning. We
recommend DBE exclusively for patients with CE retention as an alternative
to surgery and plan to conduct a multicenter retrospective analysis to further
our findings.
247
Teduglutide, A Novel Analog of Glucagon-like Peptide 2 (GLP-2), Is Effec-
tive and Well Tolerated in Reducing Parenteral Support (PS) Volume in
Short Bowel Syndrome-Intestinal Failure (SBS-IF) Subjects: Results from
a 24-week, Placebo-Controlled Phase 3 Trial
Stephen O’Keefe, MD, MSc,1 Palle Jeppesen, MD, Dr. Sci, PhD,2 Marek
Pertkiewicz, MD, PhD,3 Douglas Seidner, MD,4 Hartmut Heinze, MD,5
Bo Joelsson, MD6. 1. University of Pittsburgh, Pittsburgh, PA; 2. Rigshospitalet,
Copenhagen, Denmark; 3. Medical University of Warsaw, Warsaw, Poland;
4. Vanderbilt University Medical Center, Nashville, TN; 5. Nycomed GmbH,
Konstanz, Germany; 6. NPS Pharmaceuticals, Bedminster, NJ.
Purpose: Teduglutide, a dipeptidyl peptidase-IV degradation-resistant analog
of human GLP-2, repairs and restores functional and structural integrity of
the intestinal mucosa, increasing villous height and crypt depth. The purpose
of this study was to evaluate teduglutide 0.05 mg/kg/d given subcutaneously
(SC) when compared with placebo on its ability to reduce the PS volume
(IV fluids, nutrients, or both) in SBS-IF subjects dependent on PS.
Methods: Eighty-six SBS-IF subjects, dependent on PS for ≥1 year, were
enrolled in a randomized, double-blind, placebo-controlled, parallel-group,
multinational, multi-center, 2-stage study. After an initial optimization/
stabilization period of PS and urine volume, subjects were randomized to
teduglutide 0.05 mg/kg/d SC or placebo for 24 weeks. A responder was
defined as a subject who experienced a 20% to 100% reduction from base-
line in weekly PS volume at weeks 20 and 24. The primary efficacy endpoint
of the study compared the percentage of responders on teduglutide vs
placebo.
Results: Seventy-eight SBS-IF subjects completed the study (teduglutide 0.05
mg/kg/d, n=39; placebo, n=39). In intention-to-treat (ITT) population, 63%
(27/43) of SBS-IF subjects on teduglutide 0.05 mg/kg/d were responders vs
30% (13/43) receiving placebo (p=0.002). Significant response was seen in the
teduglutide subjects as early as week 8 and increased through week 24 com-
pared with placebo in SBS-IF subjects. At week 24, teduglutide reduced mean
weekly PS volume by 4.4 L/wk (12.9 L/wk at baseline), whereas PS volume
reduction with placebo was 2.3 L/wk (13.2 L/wk at baseline; p≤0.001). Sig-
nificantly more teduglutide-treated subjects were able to reduce the number of
infusion days per week by 1 or more days than placebo (21/39 subjects, 54%
vs 9/39 subjects, 23%; p=0.0047). Teduglutide was well tolerated; of the 8 dis-
continued, 3 of 4 in placebo group and 2 of 4 in teduglutide group were due to
adverse events (AEs). AEs were found in 83% (35/42) treated with teduglutide
vs 79% (34/43) in subjects treated with placebo. The most common AEs were
abdominal pain, nausea, gastrointestinal stoma complications, and abdominal
distension.
Conclusion: Teduglutide 0.05 mg/kg/d SC, was effective and well tolerated in
reducing weekly PS volume. Independence from PS, characterized by fewer
days per week of PS infusion, was significantly greater with teduglutide.
Disclosure: Dr. O’Keefe - Advisory Board Member: NPS Pharmaceuticals
Dr. Jeppesen - Consultant: NPS Pharmaceuticals, Consultant: Nycomed GmbH
Dr. Pertkiewicz - Consultant: NPS Pharmaceuticals, Member of Advisory Board:
Nutricia Scientific Foundation, Lectures at Teaching Workshops Dr. Seidner -
Grant/Research Support: NPS Pharmaceuticals, Consultant: Abbott Labo-
ratories, Consultant: B. Braun Dr. Heinze - Employee: Nycomed GmBH
Dr. Joelsson - Employee: NPS Pharmaceuticals.
The American Journal of Gastroenterology