Prebiotic group will take 15 grams of prebiotic product Synergy-1 per day for 6 months. Synergy-1 is chicory-derived β-fructans inulin plus FOS (1:1). During the first two weeks the patient is advised to take 7.5 g of the product at breakfast only. Starting in week 3 until the end of the treatment the participant will take 7.5 g at breakfast and 7.5 g at dinner for a total of 6 months, or until you experience a flare.

Placebo group will take 15 grams of maltodextrin per day for 6 months. Maltodextrin is a sugar adsorbed in the small bowel with no effect on the colonic intestinal microbiota. During the first two weeks the patient is advised to take 7.5 g of the product at breakfast only. Starting in week 3 until the end of the treatment the participant will take 7.5 g at breakfast and 7.5 g at dinner for a total of 6 months, or until you experience a flare.

Ulcerative Colitis

Synergy-1 is chicory-derived β-fructans inulin plus FOS (1:1).

Synergy-1

Maltodextrin is carbohydrate adsorbed in the small bowel.

Maltodextrin

University of Alberta

Ulcerative Colitis Relapse Prevention by Prebiotics

Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms

The percentage of patients that experienced relapse during the treatment period in prebiotic group versus that in the placebo group. Percentage will be calculated using the number of patients that relapse divided to the total number of patients in the treatment group. Relapse is defined as an total Mayo score of 3 or more with an endoscopy grade equal to or more than 2, and rectal bleeding for at least 3 days.

This will be assessed by package counting at 3 and 6 months or at relapse

The number of patients that experience adverse events related to treatment. This will be assessed by structured questionnaire at 3 and 6 months or at relapse

Endoscopic disease activity will be determined during sigmoidoscopy at baseline and 6 month or at relapse

Mucosal inflammation will be determined by fecal calprotectin concentration at baseline and at months 1, 3 and 6 or during relapse

Total Mayo score will be determined at baseline and at 6 months of treatment, or during a relapse.

Biopsies collected during the sigmoidoscopy procedure at baseline and at month 6 or at relapse will be used in histology analysis to determine the degree of microscopic inflammation.

Levinus Dieleman

Professor

University of British Columbia

The experimental arm of this study will involve all patients in this study. Subjects will be evaluated in a clinical setting and undergo a brief healthcare questionnaire, blood work, and a breath test. Subjects will then take a medical food (EnteraGam) twice daily for 8 weeks total, after which they will be seen in clinic at 4 weeks for follow up and then at 8 weeks to repeat the healthcare questionnaire, breath tests, and blood draw.

Cirrhosis of the Liver

Ascites

Spontaneous Bacterial Peritonitis

Visit 1, screening (Day 0): At this visit, the investigators of the study will:
Obtain demographic information, as will past medical history and medications.
Perform a physical examination.
Collect samples for labs
Administer the Chronic Liver Disease Questionnaire (CLDQ)
Perform a lactulose breath test
From Day 0 to 8 weeks: subjects will take the medical food twice daily
Visit 2, Week 4 (Day 28 +/- 3): At this visit, the investigators of the study will:
Perform a physical examination
Collect and record returned investigational product
Dispense investigational product and instruct again regarding use
Record any adverse events
Visit 3, Week 8 (Day 56 +/- 3): At this visit, the investigators of the study will:
Perform a physical examination.
Collect samples for labs
Administer the Chronic Liver Disease Questionnaire (CLDQ)
Perform a lactulose breath test

Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin)

Saint Louis University Salus Center, GI/Hepatology Clinical Studies Unit

Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites

LBP (Lipopolysaccharide binding protein)
Soluble CD14
Procalcitonin
high sensitivity C-Reactive Protein (CRP)
Intestinal Fatty Acid Binding Protein (I-FABP)

Hydrogen breath test (using lactulose as the substrate)

Quality of life will be determined with the use of the Chronic Liver Disease Questionnaire (CLDQ), a validated questionnaire used in subjects with cirrhosis. The CLDQ includes 29 questions in six domains: abdominal symptoms (three questions), fatigue (five questions), systemic symptoms (five questions), activity (three questions), emotional function (eight questions), and worry (five questions).

Muhammad Hammami, MD

Housestaff Resident

St. Louis University

American College of Gastroenterology

Entera Health, Inc

7.5 g/day dose of Synergy1 (oligofructose enriched inulin 1:1) for 9 weeks. The daily dose is dispersed in two sachets of 3.75 g each which are consumed at breakfast and dinner

15 g/day dose of Synergy1 (oligofructose enriched inulin 1:1) for 9 weeks. The daily dose is dispersed in two sachets of 7.5 g each which are consumed at breakfast and dinner

The prebiotic preparation, Synergy-1, consists of 1:1 inulin and oligosaccharide. The chicory derived inulin has a degree of polymerization (DP) of 10 to 60 (average DP of 25). The oligofructose is produced by partial enzymatic hydrolysis of chicory derived inulin and has a DP ranging between 3 and 7 (average DP of 4).

Synergy1

Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis

Open-Label Trial of a Prebiotic Preparation Containing Inulin and Oligofructose (Synergy-1) for the Treatment of Mild to Moderate Acute Ulcerative Colitis

Mayo score is a total of bowel frequency, rectal bleeding, endoscopic score and physician's rating of severity, each of the parameters on the scale 0-3.

Clinical and endoscopic remission is defined as a score of 0 in the rectal bleeding and stool frequency parts of the Mayo together with a score of 0 or 1 in the sigmoidoscopic portion of the Mayo. The total Mayo score must not be greater than 2.

inulin/hémorragie

Ulcerative Colitis Relapse Prevention by Prebiotics

Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites

Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis

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