Registry for Participants With Short Bowel Syndrome

IDENTIFIERS
Trial Protocol: TED-R13-002
Clinicaltrials.gov: NCT01990040
EUPAS: EUPAS7973
PURPOSE

This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.

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Trial at a glance

What medical condition is being studied?   Short Bowel Syndrome (SBS)
How many participants are being enrolled?   1310
When is the trial being conducted?    - 
How long is participation in the trial?   This is a long-term registry planned for 7 years of enrollment with at least 10 years of follow-up per patient.

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   N/A
Trial Type:   Observational [Patient Registry]
Trial Arms/Groups or Cohorts:   
Teduglutide treated: SBS participants who have been treated with teduglutide.
Non-teduglutide treated: SBS participants who have not been treated with teduglutide.
Primary Outcome Measure(s):
Occurrence of Colorectal Cancer in Short Bowel Syndrome (SBS) Participants With a Remnant Colon Currently Being Treated With or Ever Having Been Treated With Teduglutide [Time Frame: 10 years]
Secondary Outcome Measure(s):   
Occurrence of Other Malignancy [Time Frame: 10 years]
Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants [Time Frame: 10 years]
Occurrence of Colorectal Polyps [Time Frame: 10 years]
Occurrence of Intestinal Obstruction [Time Frame: 10 years]
Occurrence of Pancreatic and Biliary Disease [Time Frame: 10 years]
Occurrence of Heart Failure and Other Manifestations of Volume Overload [Time Frame: 10 years]
Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide [Time Frame: 10 years]
Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide [Time Frame: 10 years]
Actual Volume Change in Parenteral Support (PS) [Time Frame: 10 years]
Percentage Volume Change in Parenteral Support (PS) [Time Frame: 10 years]
Actual Change in the Number of Days per Week on Parenteral Support (PS) [Time Frame: 10 years]
Percentage Change in the Number of Days per Week on Parenteral Support (PS) [Time Frame: 10 years]
Percent of Participants Weaning From Parental Support (PS) [Time Frame: 10 years]
Entry Criteria:
Inclusion Criteria: 1. Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS). 2. Signed informed consent and medical records release by the participant or a legally acceptable representative 3. Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months at the time of enrollment. Exclusion criteria: 1. Participants currently participating in a blinded clinical trial or their extension studies. 2. Participants who have never been on PN/IV support. 3. Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.

Trial Locations

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Childrens Hospital of Alabama

1600 7th Ave S, Birmingham, AL 35233, USA

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Tri-City Colo-Rectal Surgery

2223 E Baseline Rd Suite A, Gilbert, AZ 85234, USA

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UCLA School of Medicine

2600 Redondo Ave, Long Beach, CA 90806, USA

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Children's Hospital Los Angeles

4650 Sunset Blvd, Los Angeles, CA 90027, USA

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Cedars-Sinai Medical Center

8631 W 3rd St, Los Angeles, CA 90048, USA

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Ronald Reagan UCLA Medical Center

757 Westwood Plaza, Los Angeles, CA 90095, USA

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UCSF Benioff Children's Hospital

1975 4th St, San Francisco, CA 94158, USA

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University of Miami Ins

1320 S Dixie Hwy, Coral Gables, FL 33146, USA

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University of Florida College of Medicine

1600 SW Archer Rd m509, Gainesville, FL 32610, USA

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Parent Account

701 NW 1st Ct, Miami, FL 33136, USA

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AdventHealth

600 Courtland St, Orlando, FL 32804, USA

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Emory University

201 Dowman Dr, Atlanta, GA 30322, USA

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Jesse Brown V.A

820 S Damen Ave, Chicago, IL 60612, USA

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Rush University Medical Center

1620 W Harrison St, Chicago, IL 60612, USA

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University Surgical Associates, P.S.C.

401 E Chestnut St, Louisville, KY 40202, USA

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Ochsner Health System

1315 Jefferson Hwy, New Orleans, LA 70121, USA

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Tufts Medical Center

800 Washington St, Boston, MA 02111, USA

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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

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Boston Medical Center

One Boston Medical Center Pl, Boston, MA 02118, USA

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Henry Ford Health System

1 Ford Pl, Detroit, MI 48202, USA

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University of Mississippi Medical Center

2500 N State St, Jackson, MS 39216, USA

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The Nebraska Medical Center

Omaha, NE 68198, USA

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Manhattan Clinical Research, LLC

215 Lexington Ave 21st floor, New York, NY 10016, USA

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Dept of Hematology Treatment Center

1470 Madison Ave, New York, NY 10029, USA

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Perlmutter Cancer Center NYU Langone Health

160 E 34th St, New York, NY 10016, USA

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Stony Brook University Hospital

101 Nicolls Rd, Stony Brook, NY 11794, USA

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Duke Gastroenterology

40 Duke Medicine Circle Clinic 2J, Durham, NC 27710, USA

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Cleveland Clinic - Gastroenterology and Hepatology

2049 E 100th St, Cleveland, OH 44106, USA

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Wexner Medical Center

410 W 10th Ave, Columbus, OH 43210, USA

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Digestive Disease Specialists, Inc.

5015 N Pennsylvania Ave #303, Oklahoma City, OK 73112, USA

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Allegheny Center for Digestive Health

1307 Federal St Suite B100, Pittsburgh, PA 15212, USA

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UPMC Digestive Diseases Ctr GAS

UPMC Presbyterian, Third Floor, 200 Lothrop St, Pittsburgh, PA 15213, USA

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University of Tennessee Health Sciences Center

920 Madison Ave, Memphis, TN 38163, USA

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Vanderbilt University Medical Center Diagnostic Lab

1211 Medical Center Dr, Nashville, TN 37232, USA

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Mischer Neuroscience Associates

6411 Fannin St, Houston, TX 77030, USA

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Texas Children's Hospital

6621 Fannin St, Houston, TX 77030, USA

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The Methodist Hospital

6565 Fannin St, Houston, TX 77030, USA

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Clinical Associates in Research Therapeutics of America

1200 Brooklyn Ave #150, San Antonio, TX 78212, USA

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Colon, Stomach and Liver Center

19455 Deerfield Ave, Leesburg, VA 20176, USA

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Seattle Children's Hospital

4800 Sand Point Way NE, Seattle, WA 98105, USA

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University of Washington Seattle VAMC

1959 NE Pacific St, Seattle, WA 98195, USA

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MedStar Georgetown Transplant Institute

3800 Reservoir Rd NW, Washington, DC 20007, USA

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UW Digestive Health Center

750 University Row, Madison, WI 53705, USA

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University of Wisconsin Hospital and Clinics

600 Highland Ave, Madison, WI 53792, USA

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Fundacion Favaloro

Av. Belgrano 1782, C1093 CABA, Argentina

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Toronto General Hospital

585 University Ave, Toronto, ON M5G 2N2, Canada

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Ålborg Universitetshospital

Hobrovej 18-22, 9100 Aalborg, Denmark

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Rigshospitalet

Blegdamsvej 9, 2100 København, Denmark

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Parent

Helsinki, Finland

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CHU Nice - Hôpital de l'Archet 2

de Ginestière, 151 Route de Saint-Antoine, 06200 Nice, France

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Hopital la Timone

278 Rue Saint-Pierre, 13005 Marseille, France

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Hôpital La Timone Enfants

264 Rue Saint-Pierre, 13005 Marseille, France

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Groupe Hospitalier Sud - Hôpital Haut-Lévêque

33604 Pessac, France

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Hôpital des Enfants

330 Avenue de Grande Bretagne, 31300 Toulouse, France

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Hôpital Beaujon

100 Boulevard du Général Leclerc, 92110 Clichy, France

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Service de Professeur Senesse

37 Route de Lodève, 34080 Montpellier, France

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Clinique Saint-Yves

4 Rue Adolphe Leray, 35000 Rennes, France

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Clinique Saint-Yves

4 Rue Adolphe Leray, 35000 Rennes, France

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CHU de Grenoble - Hôpital Albert Michallon

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

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CHU de Nancy - Hôpital de Brabois Adultes

5 Rue du Morvan, 54500 Vandœuvre-lès-Nancy, France

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Clinique de pediatrie - CIC

Lille, France

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Hôpital Claude Huriez - CHU Lille

Rue Michel Polonowski, 59000 Lille, France

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Service de gastro enterologie pediatrique

59 Boulevard Pinel, 69500 Bron, France

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Centre Hospitalier Lyon Sud

165 Chemin du Grand Revoyet, 69310 Pierre-Bénite, France

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CHU de Rouen - Hôpital Charles Nicolle

37 Boulevard Gambetta, 76000 Rouen, France

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Service de geriatrie

Rue Aristide Maillol, 86000 Poitiers, France

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Assistance Publique Hopitaux de Paris

33 Boulevard de Picpus, 75012 Paris, France

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Gastro-Entérologie Hépato et Nutrition Pédiatrique

20 Rue Leblanc, 75015 Paris, France

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Service de Gastro-Entérologie Pédiatrique

17 Rue Froment, 75011 Paris, France

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Innere Medizin I und Klinische Chemie

Im Neuenheimer Feld 410, 69120 Heidelberg, Germany

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Universitaetsklinikum Tuebingen

Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany

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Isar Klinik GmbH

Sonnenstraße 24, 80331 München, Germany

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Kinder- und Jugendklinik

Loschgestraße 15, 91054 Erlangen, Germany

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Medizinische Klinik 1

Ulmenweg 18, 91054 Erlangen, Germany

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Kinderklinik im Dr. von Haunerschen Kinderspital

Lindwurmstraße 4, 80337 München, Germany

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Gastroenterologie und Hepatologie

Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany

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Allgemeine Paediatrie-Neonatologie

Giessen, Germany

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Universitaetsmedizin Rostock

Schillingallee 35, 18057 Rostock, Germany

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Klinik fuer Transplantationsmedizin

Loerstraße 23, 48143 Münster, Germany

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Klinik fuer Pneumologie-III. Medizinische Klinik

Langenbeckstraße 1, 55131 Mainz, Germany

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Gastroenterologie und Hepatologie

Liebigstraße 20, 04103 Leipzig, Germany

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Klinik und Poliklinik fuer Kinder- und Jugendmediz

Liebigstraße 20 a, 04103 Leipzig, Germany

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Charite Campus Mitte

Luisenstraße 64, 10117 Berlin, Germany

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Charite - Campus Virchow-Klinikum

Augustenburger Pl. 1, 13353 Berlin, Germany

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Gastroenterologia

76121 Barletta, Province of Barletta-Andria-Trani, Italy

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Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Via Giuseppe Massarenti, 9, 40138 Bologna BO, Italy

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U.o.C. Area Centralizzata di medicina Interna e Nu

80131 Naples, Metropolitan City of Naples, Italy

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U.O. di Gastro-Epatologia

Via Cavour, 31, 10123 Torino TO, Italy

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Baerum Hospital

Sogneprest Munthe-kaas vei 100, 1346 Gjettum, Norway

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St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

Prinsesse Kristinas gate 3, 7030 Trondheim, Norway

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Sykehuset Innlandet HF

Anders Sandvigs gate 17, 2609 Lillehammer, Norway

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Akershus universitetssykehus HF

Sykehusveien 25, 1478 Nordbyhagen, Norway

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Sykehuset i Vestfold HF

Halfdan Wilhelmsens alle 17, 3103 Tønsberg, Norway

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Servicio de Endocrinologia y Nutricion

Edificio Can Gajo, Rambla Just Oliveras, 48, 3º - 2ª, 08901 L'Hospitalet de Llobregat, Barcelona, Spain

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Servicio de Endocrinologia

Calle Pintor Cabrera, 8, 03005 Alicante (Alacant), Alicante, Spain

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Endocrinology & Nutrition Dept.

08035 Barcelona, Spain

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Servicio de Endocrinologia

Plaça de la Independència, 11, 17001 Girona, Spain

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Servicio de Endocrinologia y Nutricion

1, Calle de José Ortega y Gasset, 40, 28006 Madrid, Spain

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Dermatologia

Calle de Cáceres, 35, 28045 Madrid, Spain

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Gastroenterology Department

28046 Madrid, Spain

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Karolinska Universitetsjukhuset

Hälsovägen 13, 141 57 Huddinge, Sweden

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Lund University

Lund, Sweden

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PARENT

Stockholm, Sweden

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Salford Royal

Eccles Old Rd, Salford M6, Eccles Old Rd, Salford M6 8GW, UK

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Southampton General Hospital

Tremona Rd, Southampton SO16 6YD, UK

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St. Mark's Hospital

Watford Rd, Harrow HA1 3UJ, UK

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Dept of Gastroenterology

Steelhouse Ln, Birmingham B4 6NH, UK

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University College London Hospitals

235 Euston Rd, Bloomsbury, London NW1 2BU, UK

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Great Ormond Street Hospital for Children

Great Ormond Street, Holborn, London WC1N 3JH, UK

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Del Sol Research Management, LLC

5700 E Pima St Suite A, Tucson, AZ 85712, USA

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Gastroenterology Associates of Fairfield County

2660 E Main St, Bridgeport, CT 06606, USA

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Palmetto Professional Research, Corp

2001 W 68th St, Hialeah, FL 33016, USA

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Global Health Research Center

14505 Commerce Way, Hialeah, FL 33016, USA

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University of Miami Schiff Center for Liver Disease

1500 NW 12th Ave #1101, Miami, FL 33136, USA

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Florida Medical Center and Research Inc

1501 NW 36th St, Miami, FL 33142, USA

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Cordova Research Institute

Miami, FL 33155, USA

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Sanitas Research

6741 Coral Way #44, Miami, FL 33155, USA

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Med-Care Research

1648 NE 163rd St, North Miami Beach, FL 33162, USA

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Riley Hospital for Children

705 Riley Hospital Dr, Indianapolis, IN 46202, USA

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University of Kansas Medical Center Research Institute, Inc.

3901 Rainbow Blvd, Kansas City, KS 66160, USA

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Saint Luke's Hospital of Kansas City

4401 Wornall Rd, Kansas City, MO 64111, USA

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Saint Barnabas Health Care System

94 Old Short Hills Rd, Livingston, NJ 07039, USA

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Metabolic Medicine & Weight Control Center

435 South St, Morristown, NJ 07960, USA

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The Gastroenterology Group of South Jersey

602 W Sherman Ave, Vineland, NJ 08361, USA

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Montefiore Medical Center PRIME

111 E 210th St, The Bronx, NY 10467, USA

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University of North Carolina at Chapel Hill

Chapel Hill, NC, USA

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Northwest Gastroenterology Clinic, LLC

501 N Graham St # 465, Portland, OR 97227, USA

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Midwest Medical Car

1905 W 57th St #1, Sioux Falls, SD 57108, USA

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Gastroenterology Research of San Antonio, LLC

8550 Datapoint Dr #230, San Antonio, TX 78229, USA

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Digestive Health Center

1215 Lee St Main Floor, Charlottesville, VA 22903, USA

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Universitaetsklinikum Magdeburg A.oe.R

Leipziger Str. 44, 39120 Magdeburg, Germany

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Geneva University Hospital

Rue Gabrielle-Perret-Gentil 4, 1205 Genève, Switzerland

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Trial Protocol ID: TED-R13-002
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