Inflammatory Bowel Disease
Conditions
Interventions
Group A - OPTIGUT PRO (Experimental group): Participants will receive a capsule of OPTIGUT PRO every 12 hours by oral route during 6 months. The capsule is a high-precision symbiotic formulation desig
Sponsors
Hermanos Ameijeiras Clinical Surgical Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged between 19 and 70 years , regardless of sex or skin color, who provide their consent to participate in the study. 2. Individuals with a presumptive diagnosis of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) in the Gastroenterology services of the Gastroenterology Institute of Cuba, diagnosed through barium studies of the entire digestive tract (1-X-ray of esophagus, stomach, and duodenum; 2-Intestinal transit; 3-Colon enema, also known as barium enema), abdominal ultrasound (US), or abdominal computed tomography (CT), accompanied by calprotectin levels equal to or greater than 100 µg/g. 3. Not taking probiotic formulations at the time of enrollment in the study. 4. Fecal calprotectin levels less than or equal to 100 µg/g.
Exclusion criteria
Exclusion criteria: 1. Individuals with intestinal alterations not yet classified within the two studied conditions. 2. Individuals with the studied dysbiosis who are taking any type of probiotic formulation at the start of the study. 3. Individuals who do not provide their consent to participate in the study. 4. Individuals who are taking TNF inhibitors, e.g., Humira.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calprotectin Levels (It is considered a biomarker of intestinal inflammation. Increased levels correlate well with the progression of Crohn's disease. Fecal calprotectin concentrations below 100 µg/g reliably indicate patients with a low risk of clinical recurrence in endoscopic remission settings, for whom invasive endoscopic procedures can be avoided). Measurement time: At baseline and at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life (SF-36 Health Survey in Spanish). Measurement time: At baseline and, 6 months 2. Adverse effect and its intensity (It will be measured by considering the presence of the adverse effect under four categories (No apparent adverse effect, Possible adverse effect, Similar to an adverse effect, Adverse effect) and its intensity classified into three categories (Mild, Moderate, Severe)). Measurement time: During the study, up to 6 months. 3. Muscle mass (The gain of muscle mass will be measured in grams using the TANITA bioimpedance device). Measurement time: At baseline and, at 6 months. 4. Inflammatory biomarker (IL-6 and C-Reactive Protein (CRP) will be measured. IL-6: Serum levels will be measured with normal range levels considered <5pg/ml. CRP: Serum levels will be measured with normal range levels considered between 0 and 5mg/L). Measurement time: At baseline, 3 months and, 6 months. 5. Blood chemistry (Serum levels will be evaluated considering the following normal ranges: GLUCOSE (3.3 - 6.1 mmol/L), CREATININE (47.6 - 113.4 µmol/L), CHOLESTEROL (<5.2 mmol/L), TRIGLYCERIDES (0.46 - 1.8 mmol/L), HDL (0.9 - 3 mmol/L), LDL (0 - 3.4 mmol/L), ALT (TGP)(<45 U/L), AST (TGO) (<40 U/L)). Measurement time: At baseline, 3 months and, 6 months. 6. Bacterial composition of the specific fecal microbiome (It will be determined by sequence studies of the 16S ribosome subunit (16S rRNA V3-V4) in stool samples from a group of randomly selected individuals from both groups. Taxonomic Profile and compositional analysis will be used. The taxonomic profile analysis will be performed using PICRUSt to determine the Inflammation Index, Alpha Diversity and Beta Diversity. The compositional analysis will be performed using the prediction analysis of functional markers (orthologous genes) from the study of the microbiome using LEfSe (Linear discriminant analysis Effect Size)). Measurement time: At baseline and at 6 months. | — |
Countries
Cuba
Contacts
Public ContactGissel Garcia Menendez
Hermanos Ameijeiras Clinical Surgical Hospital
Outcome results
None listed