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Ulcerative colitis (UC) is a chronic Inflammatory bowel disease (IBD) that most likely results from the interaction between various environmental and genetic factors. Using probiotics as an adjunct to medical therapy might be useful in the treatment of UC and improving the symptoms of the disease. The result of studies that investigate the role of Probiotics supplementation in improving the inflammatory response, immune response and life quality of patients with the UC is not conclusive. So, this study aimed to study the effect of probiotics on the response of inflammatory markers, immune response, and quality of life in patients with UC.
An interventional double-blind randomized clinical trial (RCT) design will be used in this study. Forty patients will be recruited and randomly assigned to the placebo group (n=20) to receive 3 times a day placebo capsules; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The demographic data, anthropometric measurements, IBD Quality of Life Questionnaire and blood samples will be collected at baseline and after 6 weeks of follow up. Interleukin-6, interleukin-1,interleukin-10 IL-10, C-reactive protein, tumor necrosis factor-alpha and complete blood count (CBC) will be measured.
The results will approve or disapprove the beneficial effect of using probiotics as adjuvant therapy for UC patients to raise the immune system as well as improving their quality of life.
To meet the objectives of the study, an interventional double-blind randomized clinical trial (RCT) design will be used in this study. A placebo group will be included in parallel with the treatment group in this trail. Forty patients (aged 35-65 years) who diagnosed with mild to moderately active UC will be recruited conveniently from the gastroenterology section, the IBD clinic at the Jordan University Hospital, Amman, Jordan. Patients who meet the inclusion criteria and agree to participate will be centrally randomized to probiotic supplementation group or placebo group using computer-generated random numbers, that balanced allocation to groups A and B: in successive blocks each containing 20 patients each stratified by gender. The duration of the intervention will be 6 weeks.
For the participants, the Jordan University Hospital setting will be utilized for data collection. The patients will be recruited over 12 months and all patients will be asked to sign a written informed consent before enrollment. The patients will randomly be assigned to the placebo group (n=20), to receive 3 times a day placebo capsules contain polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The administration of supplements will be under the supervision of the treating physician. The blood sample will be collected at baseline and at the end of 6 weeks of follow up.
The demographic data of each subject will be collected such as; gender, age, body mass index (BMI), tumor location, malignant tumors stage, tumor differentiation, educational level, occupation, family history, smoking, dietary and physical activity. At baseline and end of the follow-up, IBD Quality of Life Questionnaire will be collected and blood sample tests will be withdrawn and the following biochemical variables will be measured: immunoglobulin G, immunoglobulin M, immunoglobulin A, interleukin-6 (IL-6), C-reactive protein (CRP), interleukin-1(IL-1), interleukin-10(IL-10), interleukin-12 (IL-12), Tumor necrosis factor-alpha (TNF-α) and complete blood count (CBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Formula Capsule | Experimental | In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day |
|
| Placebos | Placebo Comparator | In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula Capsule | Drug | The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The Level of Immunoglobulin (Ig) A | The level of Immunoglobulin (Ig) A in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | at the end of 6 weeks of follow-up |
| The Level of Immunoglobulin (Ig) G | The level of Immunoglobulin (Ig) G in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | at the end of 6 weeks of follow up |
| The Level of Immunoglobulin (Ig) M | The level of Immunoglobulin (Ig) M in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | at the end of 6 weeks of follow-up |
| The Level of Interleukin (IL)-6 | The Level of Interleukin (IL)-6 in pg/ml measured aat the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | at the end of 6 weeks of follow-up |
| The Level of Interleukin (IL)-1 | The Level of Interleukin (IL)-1 in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | at the end of 6 weeks of follow-up |
| The Level of Interleukin (IL)-10 | The Level of Interleukin (IL)-10 in pg/ml was measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | at the endo f 6 weeks of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life of Patients | The average score of the general quality of life (QoL) subscales was assessed by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ contains 10 questions for 4 functional scales (Bowel, Systemic, emotional, and social). For each question, there a regraded responses on a 7-point Likert scale ranging from one (representing the ''worst'' aspect) to seven (representing the ''best'' aspect). Total SIBDQ scores range from 10 to 70.Higher scores reflect better well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| The Level of White Blood Cell Count (WBC) | The level of WBC as cells*10^9/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Level of Red Blood Cell Count (RBC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Isam Yamani, Pro.Dr | University of Jordan | Study Chair |
| Reema F Tayyem, Pro.Dr | University of Jordan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29173520 | Background | Abraham BP, Quigley EMM. Probiotics in Inflammatory Bowel Disease. Gastroenterol Clin North Am. 2017 Dec;46(4):769-782. doi: 10.1016/j.gtc.2017.08.003. Epub 2017 Oct 3. | |
| Background | Araya M, Morelli L, Reid G, et al. (2002), Guidelines for the evaluation of probiotics in food. Joint FAO/WHO Working Group report on drafting guidelines for the evaluation of probiotics in food, London; (ON, Canada). ftp://ftp.fao.org/es/esn/food/wgreport2.pdf (Accessed 19March, 2018). | ||
| 22795953 |
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The center (Jordan University hospital) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
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Assessed for eligibility (n=300)
Excluded (n= 270)
Randomized (n=30)
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste. Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks. |
| FG001 | Probiotic Group | In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Probiotic Formula Capsule | In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Level of Immunoglobulin (Ig) A | The level of Immunoglobulin (Ig) A in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | Posted | Mean | Standard Deviation | mg/dL | at the end of 6 weeks of follow-up |
|
two month period for each patient
Non
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probiotic Formula Capsule | In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lana M. Agraib | The University of Jordan | +962 | 00000 | lanamg2007@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2022 | Nov 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2023 | Sep 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| Placebos | Drug | The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks. |
|
|
| The Level of Tumor Necrosis Factor (TNF)-α | The Level of TNF-α in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | at the endo of 6weeks of follow-up |
| The Level of C-reactive Protein (CRP) | The Level of CRP in mg/ml measured at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | at the end of 6 weeks of follow-up |
| at the end of 6 weeks of follow-up |
The level of RBC as cells*10^12/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i |
| at the end of 6 weeks of follow-up |
| The Mean Corpuscular Volume (MCV) | The MCV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Mean Corpuscular Hemoglobin (MCH) | The MCH in pg measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Mean Corpuscular Hemoglobin Concentration (MCHC) | The MCH in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Platelet Count | The Platelet count as cells 10^9/ll measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The of Hemoglobin | The Hemoglobin in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Mean Platelet Volume (MPV) | The MPV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Level of Lymphocytes | The number of lymphocytes cells as cells*10^9/L measuredat the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Level of Monocytes | The number of Monocytes cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Level of Eosinophils | The number of eosinophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Level of Basophils | The number of basophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| The Level of Neutrophils | The number of neutrophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | at the end of 6 weeks of follow-up |
| Background |
| Bamias G, Corridoni D, Pizarro TT, Cominelli F. New insights into the dichotomous role of innate cytokines in gut homeostasis and inflammation. Cytokine. 2012 Sep;59(3):451-9. doi: 10.1016/j.cyto.2012.06.014. Epub 2012 Jul 12. |
| 27150635 | Background | Bengtsson J, Adlerberth I, Ostblom A, Saksena P, Oresland T, Borjesson L. Effect of probiotics (Lactobacillus plantarum 299 plus Bifidobacterium Cure21) in patients with poor ileal pouch function: a randomised controlled trial. Scand J Gastroenterol. 2016 Sep;51(9):1087-92. doi: 10.3109/00365521.2016.1161067. Epub 2016 May 6. |
| 27525288 | Background | Cai S, Kandasamy M, Rahmat JN, Tham SM, Bay BH, Lee YK, Mahendran R. Lactobacillus rhamnosus GG Activation of Dendritic Cells and Neutrophils Depends on the Dose and Time of Exposure. J Immunol Res. 2016;2016:7402760. doi: 10.1155/2016/7402760. Epub 2016 Jul 20. |
| 30502748 | Background | Dargahi N, Johnson J, Donkor O, Vasiljevic T, Apostolopoulos V. Immunomodulatory effects of probiotics: Can they be used to treat allergies and autoimmune diseases? Maturitas. 2019 Jan;119:25-38. doi: 10.1016/j.maturitas.2018.11.002. Epub 2018 Nov 12. |
| 21991534 | Background | de Moreno de Leblanc A, Del Carmen S, Zurita-Turk M, Santos Rocha C, van de Guchte M, Azevedo V, Miyoshi A, Leblanc JG. Importance of IL-10 modulation by probiotic microorganisms in gastrointestinal inflammatory diseases. ISRN Gastroenterol. 2011;2011:892971. doi: 10.5402/2011/892971. Epub 2011 Feb 8. |
| 31272578 | Background | Feuerstein JD, Moss AC, Farraye FA. Ulcerative Colitis. Mayo Clin Proc. 2019 Jul;94(7):1357-1373. doi: 10.1016/j.mayocp.2019.01.018. |
| 30837080 | Background | Gajendran M, Loganathan P, Jimenez G, Catinella AP, Ng N, Umapathy C, Ziade N, Hashash JG. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2. |
| 30632114 | Background | Guandalini S, Sansotta N. Probiotics in the Treatment of Inflammatory Bowel Disease. Adv Exp Med Biol. 2019;1125:101-107. doi: 10.1007/5584_2018_319. |
| 22196482 | Background | Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138. |
| 28404201 | Background | Kaplan GG, Ng SC. Globalisation of inflammatory bowel disease: perspectives from the evolution of inflammatory bowel disease in the UK and China. Lancet Gastroenterol Hepatol. 2016 Dec;1(4):307-316. doi: 10.1016/S2468-1253(16)30077-2. Epub 2016 Nov 10. |
| 27507542 | Background | Konishi H, Fujiya M, Tanaka H, Ueno N, Moriichi K, Sasajima J, Ikuta K, Akutsu H, Tanabe H, Kohgo Y. Probiotic-derived ferrichrome inhibits colon cancer progression via JNK-mediated apoptosis. Nat Commun. 2016 Aug 10;7:12365. doi: 10.1038/ncomms12365. |
| 37498369 | Derived | Rayyan YM, Agraib LM, Alkhatib B, Yamani MI, Abu-Sneineh AT, Tayyem RF. Does probiotic supplementation improve quality of life in mild-to-moderately active ulcerative colitis patients in Jordan? A secondary outcome of the randomized, double-blind, placebo-controlled study. Eur J Nutr. 2023 Oct;62(7):3069-3077. doi: 10.1007/s00394-023-03207-8. Epub 2023 Jul 27. |
| 36184252 | Derived | Agraib LM, Yamani MI, Tayyem R, Abu-Sneineh AT, Rayyan YM. Probiotic supplementation induces remission and changes in the immunoglobulins and inflammatory response in active ulcerative colitis patients: A pilot, randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2022 Oct;51:83-91. doi: 10.1016/j.clnesp.2022.08.020. Epub 2022 Aug 20. |
| BG001 | Placebos | In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste. Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ethnicity | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Family history of IBD | Count of Participants | Participants |
|
| History of Probiotic use | Count of Participants | Participants |
|
| Probiotic Group |
In this intervention arm, the patients will receive oral viable capsules of probiotic contain (1*10 10 colony-forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day Probiotic Formula Capsule: The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks. |
|
|
| Primary | The Level of Immunoglobulin (Ig) G | The level of Immunoglobulin (Ig) G in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | Posted | Mean | Standard Deviation | mg/dL | at the end of 6 weeks of follow up |
|
|
|
| Primary | The Level of Immunoglobulin (Ig) M | The level of Immunoglobulin (Ig) M in mg/dL was tested at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | Posted | Mean | Standard Deviation | mg/dL | at the end of 6 weeks of follow-up |
|
|
|
| Primary | The Level of Interleukin (IL)-6 | The Level of Interleukin (IL)-6 in pg/ml measured aat the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | Posted | Mean | Standard Deviation | pg/ml | at the end of 6 weeks of follow-up |
|
|
|
| Primary | The Level of Interleukin (IL)-1 | The Level of Interleukin (IL)-1 in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | Posted | Mean | Standard Deviation | pg/ml | at the end of 6 weeks of follow-up |
|
|
|
| Primary | The Level of Interleukin (IL)-10 | The Level of Interleukin (IL)-10 in pg/ml was measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | Posted | Mean | Standard Deviation | pg/ml | at the endo f 6 weeks of follow-up |
|
|
|
| Primary | The Level of Tumor Necrosis Factor (TNF)-α | The Level of TNF-α in pg/ml measured at the end of follow-up (after 6 weeks of follow-up) by a two-site sandwich Enzyme-Linked Immunosorbent Assay (ELISA) | Posted | Mean | Standard Deviation | pg/ml | at the endo of 6weeks of follow-up |
|
|
|
| Primary | The Level of C-reactive Protein (CRP) | The Level of CRP in mg/ml measured at the end of follow-up (after 6 weeks of follow-up) based on an Immunoturbidimetric assay using Cobas-C501 | Posted | Mean | Standard Deviation | mg/L | at the end of 6 weeks of follow-up |
|
|
|
| Secondary | Quality of Life of Patients | The average score of the general quality of life (QoL) subscales was assessed by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ). The SIBDQ contains 10 questions for 4 functional scales (Bowel, Systemic, emotional, and social). For each question, there a regraded responses on a 7-point Likert scale ranging from one (representing the ''worst'' aspect) to seven (representing the ''best'' aspect). Total SIBDQ scores range from 10 to 70.Higher scores reflect better well-being. | Posted | Mean | Standard Deviation | points | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of White Blood Cell Count (WBC) | The level of WBC as cells*10^9/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells10^9/l | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of Red Blood Cell Count (RBC) | The level of RBC as cells*10^12/l measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells10^12/ul | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Mean Corpuscular Volume (MCV) | The MCV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | fl | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Mean Corpuscular Hemoglobin (MCH) | The MCH in pg measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | pg | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Mean Corpuscular Hemoglobin Concentration (MCHC) | The MCH in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | g/dl | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Platelet Count | The Platelet count as cells 10^9/ll measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells*10^9/l | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The of Hemoglobin | The Hemoglobin in g/dl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | g/l | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Mean Platelet Volume (MPV) | The MPV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | fl | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of Lymphocytes | The number of lymphocytes cells as cells*10^9/L measuredat the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells*10^9/L | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of Monocytes | The number of Monocytes cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells10^9/l | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of Eosinophils | The number of eosinophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells10^9/l | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of Basophils | The number of basophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells10^9/l | at the end of 6 weeks of follow-up |
|
|
|
| Other Pre-specified | The Level of Neutrophils | The number of neutrophils cells measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i | Posted | Mean | Standard Deviation | cells10^9/l | at the end of 6 weeks of follow-up |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebos | In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste. Placebos: The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D019602 |
| Food and Beverages |