Colitis, Ulcerative
Conditions
Interventions
The present study will be a randomized, double-blind, placebo-controlled clinical trial. The study will be divided into five moments, which are called screening, week 1, week 4, week 7 and week 10 (fo
SP4.606.635.419.372
Sponsors
Hospital das Clínicas da Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: sex: men and women; age: adults and elderly people (18-80 years old); time since diagnosis of ulcerative colitis: more than six months from the beginning of the experimental protocol, being confirmed by radiological, endoscopic, and/or histological analyses; disease activity: mild or moderate clinical stage, according to the Mayo score, and fecal calprotectin higher than 300 ug/g; other diseases: patients without recurrent enteric infections, not requiring surgery and without high severity for intestinal, hepatic, renal, endocrine, respiratory, neurological, and/or cardiovascular diseases; biological condition: non-pregnant and non-lactating women; medication: patients receiving medication for ulcerative colitis beginning more than 6 months after diagnosis and patients not receiving antibiotics; diet and body weight: omnivores and patients who do not consume drinks or foods based on berries (red fruits) and/or rich in bioactive compounds; with low or adequate consumption of dietary fiber; and eutrophic or overweight according to the Body Mass Index; and non-alcohol dependent and non-smokers
Exclusion criteria
Exclusion criteria: Exclusion criteria: age: children and adolescents (0-18 years); time since diagnosis of ulcerative colitis: less than six months from the start of the experimental protocol, being confirmed by radiological, endoscopic, and/or histological analyses; disease activity: normal/remission or severe clinical stage, according to the Mayo score, and fecal calprotectin lower than 300 ug/g; other diseases: patients with recurrent enteric infections, requiring surgery and with high severity for intestinal, hepatic, renal, endocrine, respiratory, neurological and/or cardiovascular diseases; biological condition: pregnant and lactating women; medication: patients receiving medication for ulcerative colitis beginning less than 6 months after diagnosis and patients receiving antibiotics; diet and body weight: vegetarians and patients who continuously use drinks or foods based on berries (red fruits) and/or rich in bioactive compounds; who consume a high level of dietary fiber; and obese or malnourished according to BMI; and alcohol dependents and smokers. Additionally, during the implementation of the experimental protocol, the following exclusion criteria will be adopted: patients with complications or in need of changing drug therapy that violates the inclusion criteria; and patients who decide to withdraw from the study or who are unable to follow the recommendations of the experimental protocol (more than 20% failure to adhere to treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The consumption of dry extract from the peel of jaboticaba (Plinia jaboticaba) is expected to be safe for consumption; reduce clinical scores, through a decrease in criteria such as bowel frequency, evacuation urgency and/or blood in the stool; as well as improve the patient's quality of life through an increase in the Short Inflammatory Bowel Disease Questionnaire score. | — |
Secondary
| Measure | Time frame |
|---|---|
| The consumption of the dry extract from the peel of jaboticaba (Plinia jaboticaba) is expected to reduce the fecal levels of calprotectin, indicating a decrease in the gastrointestinal inflammatory process; decrease the levels of proinflammatory cytokines in serum; increase the diversity of bacterial species and regulate the intestinal microbiota through a greater participation of probiotic bacteria (examples: Bifidobacterium ssp., Lactobacillus ssp.) and less pathogenic bacteria (example: Escherichia coli); and reach one or more of the cutoff points indicative of remission or clinical response. | — |
Countries
Brazil
Contacts
Public ContactRoberto;Raquel Nascimento;Leal
Universidade Estadual de Campinas;Universidade Estadual de Campinas
Outcome results
None listed