Clinical trial NCT04223479: Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan
Official title: Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
immune system
Inflammatory markers
Probiotics
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The Level of Immunoglobulin (Ig) A
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Immunoglobulin (Ig) G
timeFrame: at the end of 6 weeks of follow up
measure: The Level of Immunoglobulin (Ig) M
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Interleukin (IL)-6
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Interleukin (IL)-1
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Interleukin (IL)-10
timeFrame: at the endo f 6 weeks of follow-up
measure: The Level of Tumor Necrosis Factor (TNF)-α
timeFrame: at the endo of 6weeks of follow-up
measure: The Level of C-reactive Protein (CRP)
timeFrame: at the end of 6 weeks of follow-up
Secondary outcomes:
measure: Quality of Life of Patients
timeFrame: at the end of 6 weeks of follow-up
Other outcomes:
measure: The Level of White Blood Cell Count (WBC)
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Red Blood Cell Count (RBC)
timeFrame: at the end of 6 weeks of follow-up
measure: The Mean Corpuscular Volume (MCV)
timeFrame: at the end of 6 weeks of follow-up
measure: The Mean Corpuscular Hemoglobin (MCH)
timeFrame: at the end of 6 weeks of follow-up
measure: The Mean Corpuscular Hemoglobin Concentration (MCHC)
timeFrame: at the end of 6 weeks of follow-up
measure: The Platelet Count
timeFrame: at the end of 6 weeks of follow-up
measure: The of Hemoglobin
timeFrame: at the end of 6 weeks of follow-up
measure: The Mean Platelet Volume (MPV)
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Lymphocytes
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Monocytes
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Eosinophils
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Basophils
timeFrame: at the end of 6 weeks of follow-up
measure: The Level of Neutrophils
timeFrame: at the end of 6 weeks of follow-up
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: University of Jordan
name: Mohammed Isam Yamani, Pro.Dr
role: STUDY_CHAIR
affiliation: University of Jordan
name: Reema F Tayyem, Pro.Dr
role: STUDY_CHAIR
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