People with celiac disease who compliant to gluten-free diet (GFD) when they accepted in the study

People with celiac disease who noncompliant to the gluten-free diet (NGFD) group when they accepted in the study

5 ml peripheral whole venous blood sample after 8-12 hour fasting

Celiac Disease

Nutritional Deficiency

Quality of Life

Investigation of intestinal permeability by measuring serum zonulin levels in blood sample

Blood draw once a time

World Health Organization (WHO) classification of BMI

Marmara University Institute of Health Sciences

Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease

The Investigation of Nutritional Status, Intestinal Permeability and Quality of Life in People With Celiac Disease

Zonulin accepted as an indicator of increased intestinal barrier permeability in previous studies . In this research protocol, zonulin kits were used and zonulin levels were analyzed by sandwich enzyme linked immunosorbent assay (ELISA) method in both celiac patients compliant to gluten free diet group and noncompliant to gluten free diet group.

Three-day food consumptions of patients were recorded. Food records of each patient were analyzed in "Nutrition Program, Nutrition Information Systems (BEBIS)" program and daily energy and dietary nutrient intake levels of each patient were calculated.

Body weight (kg), fat mass (kg) and muscle mass (kg) of each patient were measured with a bioelectrical impedance analysis (BIA) based body composition analyzer.

Certain anthropometric measurements of each patient were taken. Height (cm) was measured with a stadiometer. Tape measurements of waist circumference (cm) and hip circumference (cm) were recorded.

The ratio of waist circumference to hip circumference was calculated by dividing waist circumference measurement value (cm) to hip circumference measurement value (cm).

Celiac disease quality of life questionnaire specific to Turkish celiac population was performed. The questionnaire includes twenty eight questions and total point of questionnaire is between 0-196. Total low point indicates low quality of life, high point indicates high quality of life for people with celiac disease.

Yeşim Öztekin

Principal Investigator

Marmara University

serum IgA-tissue transglutaminase antibody (tTG) was analyzed in serum using a quantitative automated ELISA method by means of a commercially available detection kit using recombinant human tTG as antigen recommended cut-off by the manufacturer > 8 U/mL).

upper gastrointestinal endoscopic examination will be done and the jejunal histopathological examinations will be done at the Histopathology Laboratory. The features consistent with CD included: hyperplasia of crypts, atrophy of villous, and increase of intraepithelial lymphocytes.Duodenal samples will be processed using haematoxylin/eosin staining and CD3 immunophenotyping. The number of intra-epithelial lymphocytes (IEL), the architecture of villi, and the inflammatory cell infiltration of the lamina propria will be assessed. Histopathological changes will be classified according to the Marsh-Oberhuber criteria.Lymphocytic enteropathy (Marsh 1 lesion) was defined as 25 or more IEL per 100 epithelial nuclei, and normal villous architecture.

Celiac Disease in Children

Determination of anti-tissue transglutaminase IgA antibodies serum level.

anti-tissue transglutaminase group

Intestinal biopsy for histopathology study the jejunal histopathological

biopsy group

Anti-Tissue Transglutaminase IgA Antibodies

The Diagnostic Performance of Anti-Tissue Transglutaminase IgA Antibodies Serum Level for Detection of Patients With Celiac Disease

tTG are regarded as qualitative, i.e., positive or negative.Values of tTG between 2 and 7 U/mL will be considered as doubtful positive, and those of 7 U/mL or more as positive.
cut-off of ≥7 U/mL will be used in this study.

Suzan Alaa Babran

principal Investigator

Assiut University

Oral administration of one sachet of Pentabiocel for 12 consecutive weeks.

Oral administration of one sachet of Placebo per day for 12 consecutive weeks.

Pentabiocel is the trade name of the product containing the probiotic mixture of: Lactobacillus paracasei LMG P-17504, Lactobacillus plantarum CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500 and Bifidobacterium animalis subsp lactis Bi1 LMG P -17,502.

Pentabiocel

Placebo is composed of maltodextrin which is easily digestible, being absorbed as rapidly as glucose. Maltodextrin listed by the U.S. Food and Drug Administration (FDA) as a safe food additive.

Placebo

Department of Pediatrics, via Corridoni 11

Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease

Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease: A Randomized Double Blind Placebo Controlled Trial

After three months of probiotic treatment patients will be compared with their clinical symptoms evaluating score based Celiac symptom Index (CSI) developed by Leffler DA et al.

Differences between the two treatment groups (Placebo and control )related to all the parameters evaluated and in particular: (a) Weight (in kilograms) , height (in meter) will be combined to measure BMI (at the time of enrolment and after follow up 3 and 6 months).
(b) Anti tissue transglutaminase IgA serology level in cubic inch ( CU) (at the time of enrolment and after follow up 3 and 6 months).

secale/atrophie

Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease

Anti-Tissue Transglutaminase IgA Antibodies

Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease

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