vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products

habitual diet supplemented with 2.4g/day of oral butyrate

Behcet Syndrome

Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate

Oral butyrate

Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products

Vegetarian diet

Habitual diet

AOU Careggi

Dietary Interventions and Butyrate Production in Behçet's Patients

Therapeutic Modulation of Butyrate Production in Behçet's Patients: a Dietary Intervention Trial

For the extraction of SCFAs (and butyrate in particular) the method described in Schnorr et al. will be follow" [Schnorr SL, Candela M, Rampelli S, Centanni M, Consolandi C, Basaglia G,et al. Gut microbiome of the Hadza hunter-gatherers. Nat Commun 2014;5:3654]

composite score taking into account the levels of: total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), triglycerides

composite score taking into account the levels of : glucose, insulin, glycated hemoglobin (HbA1C), HOMA index

composite score, taking into account the levels of: vitamin B12, folic acid, vitamin D

composite score taking into account the levels of: aspartate aminotransferase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), alkaline phosphatase (ALP), albumin, prealbumin

composite score taking into account the levels of : serum creatinine, urea, uric acid

composite score taking into account the levels of: sodium, potassium, magnesium, calcium

composite score taking into account the levels of: iron, ferritin

composite score taking into account the levels of: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fibrinogen, serum amyloid A (SAA)

composite score taking into account the levels of: IgA, anti-transglutaminase antibodies (IgA), anti endomysium antibodies (IgA)

Participants are asked to complete a questionnaire, which will assess Behçet's symptoms frequency and severity.

GIACOMO EMMI

Principal Investigator

Azienda Ospedaliero-Universitaria Careggi

Behçet's will be assigned to one of the following treatments:
vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
habitual diet supplemented with 2.4g/day of oral butyrate
habitual diet without supplementation

For participants assigned to the treated arm, they will follow study regime below: Intervention treatment will last from Day 0 up to Month 24.
Day 0: Subjects will receive alemtuzumab (30mg iv single dose); anakinra (100 mg sc.); etanercept (50 mg sc.) and liraglutide (0.6 mg sc.).
Day 1: Subjects will receive plerixafor (0.24 mg/kg/day) sc. to mobilize CD34+ stem cells to peripheral blood.
Day 1: Continuing with anakinra 100mg sc. daily for 12 month; etanercept 50mg sc. twice weekly for first 3 months, and 50mg sc. weekly for another 9 months; liraglutide 0.6 mg sc. daily for 7 days, then 1.2 mg sc. daily (or up to 1.8mg daily) as tolerated for 24 months.

For participant assigned to the control arm, they will be monitored and tested for the first 12 months, and receive intervention treatment from Month 12 up to Month 24.
Month 12: Subjects will receive alemtuzumab (30mg iv single dose); anakinra (100 mg sc.); etanercept (50 mg sc.) and liraglutide (0.6 mg sc.).
Month 12 + 1 day: Subjects will receive plerixafor (0.24 mg/kg/day) sc.. Month 12 + 1 day: Continuing with anakinra 100mg sc. daily for 12 month; etanercept 50mg sc. twice weekly for first 3 months, and 50mg sc. weekly for another 9 months; liraglutide 0.6 mg sc. daily for 7 days, then 1.2 mg sc. daily (or up to 1.8mg daily) as tolerated for 12 months.

Diabetes Mellitus, Type 1

Systemic CD34+ stem cell mobilization for beta-cell repair

Plerixafor

Alemtuzumab

Anakinra

Etanercept

Liraglutide

University of Alberta

Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

Autologous Hematopoietic Stem Cell Mobilization (Plerixafor) and Immunologic Reset in New Onset Type 1 Diabetes Mellitus

This AUC will be normalized by dividing it by 120 minutes (the number of minutes over which it is determined), and will be adjusted by inclusion of baseline C-peptide AUC as a covariate in the analysis.

A subject is considered a responder if at the given time point, the subject has: a) HbA1c ≤6.5% and b) mean daily insulin use < 0.5 IU/kg/day over 7 consecutive days during the 2 weeks preceding the visit.

Mean total daily insulin dose assessed over 7 consecutive days during 2 weeks preceding clinic visits

Proportion of subjects free from severe hypoglycemia reported frequency of hypoglycemia by Hypo Score and Lability Index and CGMS

Proportion of subjects who become C-peptide negative

Including GAD, ICA512, IA2A, ZnT8 and mIAA

Alberta Innovates Health Solutions

ATTR-CM

TTR-CM

Once daily 20 mg oral tafamidis (soft gelatin capsule)

tafamidis

To obtain contact information for a study center near you, click here.

Emory University School of Medicine

Pfizer Investigational Site

University of Chicago Medical Center

Johns Hopkins Hospital

Brigham and Women's Hospital

Clinical Cardiovascular Research Laboratory for the Elderly (CCRLE)

Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

Open-Label Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

amyloidosis/phosphatase

Dietary Interventions and Butyrate Production in Behçet's Patients

Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

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