Crohn Disease
Conditions
Interventions
This is a pilot, prospective, single-center, two-arm, double-blind, and partially randomized study, with a duration of 12 months per applied intervention, totaling 36 months. The study includes 93 adu
(2) Suppl Plus Group (n=39): including 27 participants with UC and 12 with CD, received the same formulation plus silymarin. The formulations were administered orally, divided into 4 daily capsules, a
Sponsors
Universidade Federal de Alagoas
Hospital Universitário Professor Alberto Antunes
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adults aged between 18 and 75 years; Confirmed diagnosis of ulcerative colitis (UC) or Crohn’s disease (CD) based on clinical, endoscopic, and histological criteria, and who have not used prebiotics, probiotics, or synbiotics in the 6 months prior to data collection; Stable maintenance therapy for at least 3 months prior to inclusion; Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Having undergone any gastrointestinal surgery in the last 6 months; Severe anemia; Chronic obstructive pulmonary disease; Life expectancy of less than 3 months; Patients diagnosed with sleep apnea; American Society of Anesthesiologists (ASA) score greater than or equal to three; Patients unable to undergo endoscopy/colonoscopy; Use of antibiotics in the four weeks prior to inclusion; Pregnancy or breastfeeding; Significant hepatic, renal, or cardiac comorbidities; History of intestinal resection greater than 40 cm; Active infection or malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the nutraceutical intervention will be effective in maintaining remission of Inflammatory Bowel Disease (IBD), verified by the Mayo Score method for Ulcerative Colitis, defining remission as a score lower than 2, and by the Simple Endoscopic Score for Crohn’s Disease method, with remission defined as a score lower than 8, after 12 months of treatment (highest scientific relevance);Improvement in clinical response in Inflammatory Bowel Disease (IBD) is expected after fecal microbiota transplantation (FMT), verified by the proportion of patients with no need for biological therapy and by the method of fecal calprotectin measurement, with values lower than 50 micrograms per gram after 52 weeks;To evaluate the effect of the nutraceutical intervention on the clinical evolution of patients with Ulcerative Colitis (UC), compared with placebo, verified through the analysis of the composition and diversity of the intestinal microbiota in fecal samples, using the 16S rRNA gene sequencing method, with assessment of alpha and beta diversity, with measurements performed before the start of the intervention and throughout up to 12 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in quality of life is expected in patients with Ulcerative Colitis (UC) undergoing the nutraceutical intervention, verified through the application of the Inflammatory Bowel Disease Quality of Life Index, with measurements performed during the pre-intervention period and at 6 and 12 months after the start of the intervention;A reduction in inflammatory markers is expected in patients with Ulcerative Colitis (UC) undergoing the nutraceutical intervention, compared with the placebo group, verified through the measurement method of the markers C-reactive protein (CRP), fecal calprotectin, tumor necrosis factor alpha (TNF-a), interleukin 10 (IL-10), and interleukin 22 (IL-22), with variations in these parameters analyzed between groups during the pre-intervention period and at 6 and 12 months after the start of the intervention | — |
Countries
BR
Contacts
Public ContactManoel Lins Neto
Universidade Federal de Alagoas
Outcome results
None listed