Gastroesophageal Reflux

Digestion-resistant carbohydrate, ISOT-101, a specific formulation of maltosyl-isomalto-oligosaccharides (MIMO), that serves as a prebiotic, feeding selected bacteria that commonly inhabit the human GI tract.

maltosyl-isomalto-oligosaccharides (MIMO)

ISOThrive Inc.

Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease

Open Label Tolerability Study of a Novel Microbiome Therapeutic (ISOT-101), Maltosyl-Isomalto-oligosaccharides (MIMO), in Subjects With Gastroesophageal Reflux Disease

Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention score using GERD ReQuest Short Version. The scores for weeks 1, 2, 3, and 4 will be compared with baseline. With regard to the ReQuest Short Version questionnaire, the range is 0 to 46.28 with higher numbers reflecting more severe symptoms. Tolerability is defined as the post-intervention score is equal to or less than baseline.

Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention scores using GERD ReQuest Long Version. The scores for weeks 1, 2, 3, and 4 will be compared with baseline. With regard to the ReQuest Long Version, the range is 0 to 46.28 with higher numbers reflecting more severe symptoms. Tolerability is defined as the post-intervention score is equal to or less than baseline.

Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention scores using Rand Short Form-36 (v1.0). The scores for weeks 1, 2, 3, and 4 will be compared with baseline. The range of the SF-36 scoring is 0-100 with higher numbers defining a more favorable health state. Tolerability is defined as the post-intervention score is equal to or greater than baseline.

This study will be conducted in accordance with the International Council for Harmonisation (ICH) E6 R2. The Investigator agrees to maintain adequate documentation for the subjects participating in this clinical research project. The Investigator agrees to maintain accurate case report forms and source documentation as part of the case histories. Subjects will enter their data into the data capture system (REDCap). The analysis data sets will be generated from data captured in REDCap.
All documents and data shall be produced and maintained in such a way as to assure control of documents and data to protect the subject's privacy as far as reasonably practicable. All attempts will be made to preserve subject confidentiality.

lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months

6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months

Iron-deficiency

lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron

Lactoferrin

group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron

Ferric Hydroxide Polymaltose

South Valley University

the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis

mean difference in hemoglobin level between pre treatment and post treatment. mean difference in hemoglobin level between pre treatment and post treatment.

mean difference in ferritin level between pre treatment and post treatment.

Shimaa Abdallah Ahmed

principal investigator

Ulcerative Colitis

Probiotic blend of 8 different strains of lactobacilli and bifidobacteria, dosed at 900 billion bacteria/sachet). Dosage regimen is 2 sachets b.i.d. for 8 weeks

VSL#3

Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks

Placebo

U.O. di Medicina Interna Ospedaliera Policlinico di Bari

Reparto di Gastroenterologia ed Endoscopia Digestiva Azienda Ospedaliera Pugliese-Ciaccio

U.O. Fisiopatologia Digestiva Azienda Ospedaliera Mater Domini Campus Universitario di Germaneto

U.O. di Endoscopia Digestiva Presidio Ospedaliero San Salvatore

Dipartimento di Chirurgia Generale Servizio di Endoscopia Digestiva Ospedale Santa Maria Goretti

Struttura Complessa di Medicina Interna Azienda Ospedaliera Villa Sofia - CTO Ospedale Villa Sofia

U.O. di Nutrizione Clinica Ospedale Sant'Eugenio

P.O. Nuovo Regina Margherita Unità Operativa di Endoscopia e Gastroenterologia

Dipartimento di Medicina Interna U.O. di Gastroenterologia ed Endoscopia Digestiva Ospedale Cristo Re

Istituto di Medicina Interna CIC Columbus Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore

Unità di Endoscopia Azienda Ospedaliera Sant'Andrea

Divisione di Gastroenterologia Istituto Clinico Humanitas

U.O.C. Endoscopia Digestiva IRCCS Ospedale Casa Sollievo della Sofferenza

Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis

Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study

maltose/verenvuoto

Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease

the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis

Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis

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