Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, immune system, Inflammatory markers, Probiotics
Brief summary
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.
Detailed description
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).
Interventions
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.
DRUGPlacebos
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.
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female patients, * Age between 35 -65 years, * Diagnosed with UC established by colonoscopy and histology, and suffering from mild to moderate UC as defined by Modified Mayo Disease Activity Index (MMDAI) (score 3-9).
Exclusion criteria
* Patients with age \<35 years, \>65 years, * Pregnancy, planned pregnancy, breastfeeding women, * Evidence of severe disease (MMDAI \>10), * Concurrent enteric infection, * Use of antibiotics, * Change in the dose of oral 5-aminosalicylic acid (5-ASA) within the past 4weeks, and use of rectal 5-ASA or steroids within 7 days before entry into the study, * Received any investigational medicines within 3months, * If they have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Level of C-reactive Protein (CRP) | at the end of 6 weeks of follow-up | 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 |
| The Level of Immunoglobulin (Ig) A | at the end of 6 weeks of follow-up | 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 |
| The Level of Immunoglobulin (Ig) G | at the end of 6 weeks of follow up | 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 |
| The Level of Immunoglobulin (Ig) M | at the end of 6 weeks of follow-up | 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 |
| The Level of Interleukin (IL)-6 | at the end of 6 weeks of follow-up | 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) |
| The Level of Interleukin (IL)-1 | at the end of 6 weeks of follow-up | 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) |
| The Level of Interleukin (IL)-10 | at the endo f 6 weeks of follow-up | 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) |
| The Level of Tumor Necrosis Factor (TNF)-α | at the endo of 6weeks of follow-up | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life of Patients | at the end of 6 weeks of follow-up | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Level of Monocytes | at the end of 6 weeks of follow-up | 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 |
| The Level of Eosinophils | at the end of 6 weeks of follow-up | 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 |
| The Level of White Blood Cell Count (WBC) | at the end of 6 weeks of follow-up | 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 |
| The Level of Neutrophils | at the end of 6 weeks of follow-up | 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 |
| The Level of Basophils | at the end of 6 weeks of follow-up | 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 |
| The Level of Red Blood Cell Count (RBC) | 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 |
| The Mean Corpuscular Volume (MCV) | at the end of 6 weeks of follow-up | The MCV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i |
| The Mean Corpuscular Hemoglobin (MCH) | at the end of 6 weeks of follow-up | The MCH in pg measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i |
| The Mean Corpuscular Hemoglobin Concentration (MCHC) | at the end of 6 weeks of follow-up | 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 |
| The Platelet Count | at the end of 6 weeks of follow-up | 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 |
| The of Hemoglobin | at the end of 6 weeks of follow-up | 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 |
| The Mean Platelet Volume (MPV) | at the end of 6 weeks of follow-up | The MPV in fl measured at the end of follow-up (after 6 weeks of follow-up) using the automated analyzer Sysmex XS-500i |
| The Level of Lymphocytes | at the end of 6 weeks of follow-up | 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 |
Countries
Jordan
Participant flow
Recruitment details
Assessed for eligibility (n=300) Excluded (n= 270) * Not meeting inclusion criteria (n=229) * Declined to participate (n=15) * Other reasons (n=26) Randomized (n=30)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Probiotic Formula Capsule | Placebos | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Body mass index | 25.3 kg/m^2 STANDARD_DEVIATION 6.8 | 24.6 kg/m^2 STANDARD_DEVIATION 5.7 | 24.95 kg/m^2 STANDARD_DEVIATION 6.25 |
| Ethnicity Arabs | 16 Participants | 14 Participants | 30 Participants |
| Ethnicity Others | 0 Participants | 0 Participants | 0 Participants |
| Family history of IBD No | 11 Participants | 12 Participants | 23 Participants |
| Family history of IBD Yes | 5 Participants | 2 Participants | 7 Participants |
| History of Probiotic use No | 15 Participants | 12 Participants | 27 Participants |
| History of Probiotic use Yes | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 14 Participants | 30 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Jordan | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of C-reactive Protein (CRP) | 4.65 mg/L | Standard Deviation 0.24 |
| Probiotic Group | The Level of C-reactive Protein (CRP) | 4.54 mg/L | Standard Deviation 0.14 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Immunoglobulin (Ig) A | 270.42 mg/dL | Standard Deviation 71.79 |
| Probiotic Group | The Level of Immunoglobulin (Ig) A | 208.63 mg/dL | Standard Deviation 85.84 |
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
Time frame: at the end of 6 weeks of follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Immunoglobulin (Ig) G | 1267.36 mg/dL | Standard Deviation 177.6 |
| Probiotic Group | The Level of Immunoglobulin (Ig) G | 1214.70 mg/dL | Standard Deviation 236.3 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Immunoglobulin (Ig) M | 114.64 mg/dL | Standard Deviation 62.03 |
| Probiotic Group | The Level of Immunoglobulin (Ig) M | 104.10 mg/dL | Standard Deviation 39.57 |
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)
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Interleukin (IL)-1 | 7.33 pg/ml | Standard Deviation 3.31 |
| Probiotic Group | The Level of Interleukin (IL)-1 | 8.55 pg/ml | Standard Deviation 3.45 |
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)
Time frame: at the endo f 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Interleukin (IL)-10 | 22.89 pg/ml | Standard Deviation 12.49 |
| Probiotic Group | The Level of Interleukin (IL)-10 | 37.10 pg/ml | Standard Deviation 14.95 |
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)
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Interleukin (IL)-6 | 10.84 pg/ml | Standard Deviation 3.3 |
| Probiotic Group | The Level of Interleukin (IL)-6 | 9.40 pg/ml | Standard Deviation 3.13 |
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)
Time frame: at the endo of 6weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Tumor Necrosis Factor (TNF)-α | 9.36 pg/ml | Standard Deviation 1.57 |
| Probiotic Group | The Level of Tumor Necrosis Factor (TNF)-α | 9.58 pg/ml | Standard Deviation 1.75 |
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.
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Quality of Life of Patients | 4.96 points | Standard Deviation 1.27 |
| Probiotic Group | Quality of Life of Patients | 6.54 points | Standard Deviation 0.29 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Basophils | 0 cells10^9/l | Standard Deviation 0 |
| Probiotic Group | The Level of Basophils | 0 cells10^9/l | Standard Deviation 0 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Eosinophils | 0.25 cells10^9/l | Standard Deviation 0.19 |
| Probiotic Group | The Level of Eosinophils | 0.15 cells10^9/l | Standard Deviation 0.1 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Lymphocytes | 2.50 cells*10^9/L | Standard Deviation 0.93 |
| Probiotic Group | The Level of Lymphocytes | 2.40 cells*10^9/L | Standard Deviation 0.69 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Monocytes | 0.67 cells10^9/l | Standard Deviation 0.28 |
| Probiotic Group | The Level of Monocytes | 0.59 cells10^9/l | Standard Deviation 0.16 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Neutrophils | 5.05 cells10^9/l | Standard Deviation 2.35 |
| Probiotic Group | The Level of Neutrophils | 3.56 cells10^9/l | Standard Deviation 1.59 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of Red Blood Cell Count (RBC) | 4.73 cells10^12/ul | Standard Deviation 0.55 |
| Probiotic Group | The Level of Red Blood Cell Count (RBC) | 4.95 cells10^12/ul | Standard Deviation 0.36 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Level of White Blood Cell Count (WBC) | 8.18 cells10^9/l | Standard Deviation 2.9 |
| Probiotic Group | The Level of White Blood Cell Count (WBC) | 6.72 cells10^9/l | Standard Deviation 2.01 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Mean Corpuscular Hemoglobin Concentration (MCHC) | 33.28 g/dl | Standard Deviation 0.9 |
| Probiotic Group | The Mean Corpuscular Hemoglobin Concentration (MCHC) | 33.52 g/dl | Standard Deviation 1.31 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Mean Corpuscular Hemoglobin (MCH) | 28.70 pg | Standard Deviation 3.27 |
| Probiotic Group | The Mean Corpuscular Hemoglobin (MCH) | 27.88 pg | Standard Deviation 2.96 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Mean Corpuscular Volume (MCV) | 85.68 fl | Standard Deviation 9.23 |
| Probiotic Group | The Mean Corpuscular Volume (MCV) | 83.63 fl | Standard Deviation 7.33 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Mean Platelet Volume (MPV) | 10.67 fl | Standard Deviation 1.22 |
| Probiotic Group | The Mean Platelet Volume (MPV) | 10.71 fl | Standard Deviation 0.83 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The of Hemoglobin | 13.54 g/l | Standard Deviation 2.01 |
| Probiotic Group | The of Hemoglobin | 13.78 g/l | Standard Deviation 1.54 |
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
Time frame: at the end of 6 weeks of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | The Platelet Count | 292.40 cells*10^9/l | Standard Deviation 72.05 |
| Probiotic Group | The Platelet Count | 288.18 cells*10^9/l | Standard Deviation 69.47 |