Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

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).
    

Intervention name(s): Probiotic Formula Capsule; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Probiotics capsule; Probiotics supplement; Placebo oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; immune system; Inflammatory markers; Probiotics