Patients will be enrolled and follow an identical medical treatment algorithm. At day 3 responders (based on partial Mayo score) will be re-randomized in a 1:1 fashion to complete 5 total days of HBOT (1 session per day) or to stop after 3 days of HBOT. Non-responders will be entered into an open label arm to complete 5 total days of HBOT.

Colitis, Ulcerative

Hyperbaric oxygen (HBO) provides 100% oxygen at a pressure above atmospheric pressure (typically twice to three times standard sea level pressure (2.0-3.0 ATA)). This dramatically increases the amount of oxygen dissolved in blood plasma, which in turn increases oxygen delivery to tissues. This effect of hyperbaric oxygen is used clinically to treat acute hypoxia in crush injuries, severed limbs, and failing skin grafts

Hyperbaric Oxygen Therapy

UC San Diego Health Systems

University of California San Diego

University of Maryland

Mayo Clinic

Dartmouth-Hitchcock Medical Center

NYU Langone Medical Center

University of Texas Southwestern Medical Center

Virginia Mason Memorial Hospital

Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares

Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized Trial

Impact of HBOT on clinical response/remission to medical therapy as measured by the partial Mayo score at study day 5.

Relative and absolute reduction in the Mayo score

Proportion who require cyclosporine, infliximab or colectomy during index flare

Relative absolute change in inflammatory markers: ESR

Relative absolute change in inflammatory markers: CRP

Relative absolute change in inflammatory markers: fecal calprotectin

Relative absolute change in inflammatory markers: interleukins

Relative absolute change in gene expression: VEGF

Relative absolute change in gene expression: HIF-1

Relative absolute change in gene expression: HO-1

Describe the HBOT specific changes in the microbiome composition

Corey Siegel

Section Chief, Section of Gastroenterology

Foundation for Clinical Research in IBD

The Eli and Edythe Broad Foundation

University of California, San Diego

University of Pittsburgh Medical Center

University of Maryland, College Park

NYU Langone Health

In this arm, subjects consumed a beverage

In this arm, subjects consumed a beverage with identical macronutrients

Inflammation

Milk fat globule membrane

Effect of Milk Fat Globule Membrane (MFGM) on Gut Barrier Protection in Runners

In this outcome, the barrier properties of the gut are assessed indirectly. Subjects consume a mixture of lactulose and mannitol. Mannitol is a monosaccharide and is passively absorbed from the gut and eliminated via the urine. Lactulose, on the other hand, is an indigestible disaccharide. If it appears in the urine, it is thought to pass into the body through loose tight junctions between the mouth and large intestine. If it reaches the large intestine, lactulose will be fermented by the microbiome.
Subjects consume the sugar mixture and urine is collected for 6 hours. In this study, gut permeability was measured at baseline, and after after the running tests.

Higher core temperatures are associated with increased gut permeability. Two of our primary measures were gut permeability assessments by the differential sugar test and plasma LPS. The increase in core temperature was included to give context to those measures. Prior to the exercise test, subjects consumed a thermometer pill and core temperature was monitored with a recording device.

Plasma lactate was measured as an index of exercise intensity. It was measured before the exercise challenge, and immediately after. It was also measured at 1 hour and 4 hours post exercise.

To determine the systemic inflammatory response, plasma cytokines were measured before the exercise test and at 1h and 5h later. Plasma cytokines were measured with a multiplexed ELISA kit.

Higher levels of plasma endotoxin (aka LPS) are thought to occur due to a leaky gut

Creatine kinase was measured as an index of muscle stress. It was measured before the exercise challenge, and immediately after. It was also measured at 1 hour and 4 hours post exercise.

Robert Ward

Associate Professor

Utah State University

Dairy Research Institute

The healthy volunteers and IBD patients will have a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level (m.a.s.l.) in a hypobaric pressure chamber. Before and after the pressure chamber sigmoidoscopy will be performed. During stay in the pressure chamber repetitive measurements of bladder volume will be performed by sonography.

Inflammatory Bowel Disease

hypobaric chamber: ascent within 10 minutes, 3 hour exposure to hypoxic conditions simulating an altitude of 4,000 m.a.s.l., afterwards controlled descent under continuous pulsoximetric control

hypobaric pressure chamber

To retrieve biopsies from the colon during the course of the study 3 sigmoidoscopies were performed. The first sigmoidoscopy was performed 1 day before the stay in the hypobaric chamber. The second sigmoidoscopy was performed directly after the hypobaric chamber and the third sigmoidoscopy was performed 1 week after the hypobaric chamber. During each sigmoidoscopy 6 biopsies were taken with standard size forceps (2.4 mm). One biopsy was analysed by real-time quantitative polymerase chain reaction (PCR), one biopsy was analysed by Western blotting and another biopsy was analysed for gene gene-expression by in situ hybridisation. Two biopsies were analysed by immunohistochemistry (IHC) and one biopsy was stained with hematoxylin and eosin (H&E).

Sigmoidoscopy

The Altitude Inflammatory Bowel Disease Study

A Study on the Influence of Hypoxia on Healthy Volunteers and Patients With Inflammatory Bowel Disease (IBD): The Altitude IBD Study

Harvey Bradshaw Activity Index (HBI) in Crohn's disease (CD):
To calculate the clinical activity of patients with CD the Harvey Bradshaw Activity Index (HBI) was used. This index includes general wellbeing, abdominal pain, the number of bowel movements, abdominal resistance and CD associated extraintestinal diseases. Each category has a point value assigned and from the sum of all categories a point value is calculated.

partial Mayo Score for Ulcerative Colitis (UC): To calculate the clinical activity of patients with UC the partial Mayo Score was used. This clinical index includes the stool frequency, the amount of blood in the stool and the physician rating of disease activity. Each category has a point value assigned from 0 to 3 and from the sum of all categories a point value was calculated. Remission is defined as 0-1 points, mild disease 2-4 points, moderate disease 5-6 points and severe disease as 7-9 points.

tumor necrosis factor alpha (TNF-α), tumor necrosis factor (TNF), interleukin-1β (IL-1β), interferon-gamma (IFNg), interleukin-10 (IL-10)

Assessed by sigmoidoscopy:
signs of inflammation:
decreased vascular pattern
ulcers
bleeding

University of Zurich

Triemli Hospital

Zurich Center for Integrative Human Physiology

Institute of Biostatistics

University Hospital Inselspital, Berne

Institute of Physiology Irchel

Institute of Veterinary Physiology

Swiss Aeromedical Center Switzerland

Institute of Experimental Immunology

Institute of Pathology, University Hospital Zurich

Modified release tablets containing 500 mg of propionyl-L-carnitine

Modified release tablets containing inert substances

Ulcerative Colitis

500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks

Propionyl-L-Carnitine

500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks

Placebo

Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie

Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin

Ordinationszentrum Döbling

Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III

Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun

Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie

Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie

Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif

Hôpital Nord - Dept. of Gastroenterology

Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie

Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

Hôpital Rangueil Service de gastro-enterologie

Hôpital Brabois Service de gastro-enterologie

Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik

Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56

Klinikum Braunschweig

Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

Universtätsklinikum Schleswig-Holstein Gastroenterologie

Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie

Universitätsmedizin Mannheim II. Medizinische Klinik

Praxis Prof. Dr. med. Herbert Kellner

Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin

Gastroenterologische Fachpraxis am Germania Campus

Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology

Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház

Semmelweis Egyetem 1st Internal Dept.

Pannónia Magánorvosi Centrum Kft.

Semmelweis Egyetem II. sz. Belgyógyászati Klinika

Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1

Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály

Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály

Clinfan Kft. SMO

CRU Hungary Kft.

Daugavpils Central Regional Hospital

Paula Stradina Clinical University Hospital Gastroenterology Centre

Latvian Maritime Medicine Centre

Digestive Disease Center GASTRO

Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius

Klaipedos jurininku ligonine Diagnostikos skyrius

VšI Mykolo Marcinkeviciaus ligonines

Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej

Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii

Endoskopia Sp. z o.o.

Nzoz Vivamed

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii

Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii

LexMedica

ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew

Fundación Hospital de Alcorcón Servicio de Gastroenterología

Centro Medico Teknon Servicio de Aparato Disgestivo

Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo

Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia

Hospital Universitario La Paz Servico de Gastroenterologia

Corporació Sanitaria Parc Taulí Servicio de Digestivo

Hospital Universitario Marques de Valdecilla Servicio de Digestivo

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

Remission will be defined according with the overall modified Mayo score (Disease Activity Index). A score ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1 will be considered necessary to classify the patient in remission state.

Evaluation will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).

Evaluations will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).

Evaluated as an improvement of the histological index of at least 1 point

A validated specific questionnaire, the SIBDQ by McMaster university will be administered to evaluate changes in patients' quality of life

Haemoglobin, Haematocrit, RBC, WBC and differential count.

Standard intervals (PR, RR, QRS, QT) will be collected plus all rhythm abnormalities

Standard evaluation including renal and liver function, electrolytes and blood glucose

sigma-tau i.f.r. S.p.A.

PRA Health Sciences

Modified release tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.

Tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.

Imelda Ziekenhuis

Universitaire Ziekenhuis Gasthuisberg

Universitair Ziekenhuis Gent

H. Hartziekenhuis Roeselare-Menen vzw

Derma Plus s.r.o.

Hepato-Gastroenterology HK s.r.o.

Fakultní nemocnice Olomouc

G.E.P. Clinic s.r.o.

MONSE s.r.o

Fakultní Thomayerova nemocnice s poliklinikou

Fakultní Nemocnice v Motole

Nemocnice Tábor, a.s.

Orlickoústecká Nemocnice a.s

Soroka University Medical Center

Shaare Zedek Medical Center

Hadassah Medical Organization, Ein Kerem

Meir Medical Center

Rabin Medical Center

Kaplan Medical Center

Tel Aviv Souraski Medical Center

Assaf Harofeh Medical Centre

Ospedale "G.B.Morgagni - L. Pierantoni"

Istituto Clinico Humanitas

Ospedale Luigi Sacco - Az. Osp. Dept. of Gastroenterology

Policlinico Universitario Federico II

IRCSS Policlinico San Matteo

Azienda Ospedaliera S. Camillo Forlanini, Roma

Policlinico Universitario Agostino Gemelli

Onze Lieve Vrouwe Gasthuis

Leids Universitair Medisch Centrum

UMC Utrecht

CMI de Gastroenterologie Dobru Daniela

Neomed Research

Centrul Medical Sana

Endocenter Medicina Integrativa SRL

Gastromedica SRL

Spitalul Clinic Judetean De Urgenta Sibiu

Policlinic Algomed SRL

State Scientific Centre of Coloproctology

State Educational Institution of Higher Professional Education Novosibirsk State Medical University

State Research Institute of Physiology of Siberian Branch of Russian Academy of Medical Sciences

GOU VPO Rostov State Medical University

Saint Petersburg GUZ City Policlinic 38

Regional Military Clinical Hospital ¿ 442 named after Z.P. Solovyov of Ministry of Defence of Russia

Saint-Petersburg State Institution of Health Protection City Hospital # 26

Krestovsky Medical Institute

Saratov City Hospital #2

Saint-Petersburg Medical Academy

State Educational Institution of Higher Professional Education "Stavropol State Medical Academy"

Clinical Hospital #2

NovaMed spol. s.r.o.

UNB Nemocnica Staré Mesto

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

colitis/hypoxia

Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares

Effect of Milk Fat Globule Membrane (MFGM) on Gut Barrier Protection in Runners

The Altitude Inflammatory Bowel Disease Study

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

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