The effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease

Determining the effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease

A clinical trial with a control group, parallel groups, triple blind, randomized on 84 patients.

The study will be conducted in a triple-blind manner (patient, therapist and analyst) in Hazrat Rasool Akram Hospital. People's food intake is evaluated with a 24-hour recal. Scores of disease activity questionnaires in ulcerative colitis and Crohn's disease, quality of life and international physical activity will be evaluated before and after the intervention. Stool samples will be taken from patients before and after the intervention. Nutrient analysis will be done using N4 software.

Inclusion criteria: Having mild to moderate disease activity in ulcerative colitis and mild to moderate disease activity in Crohn's; Minimum age of 18 years and maximum of 70 years Exclusion criteria: The use of anticoagulants, anti-tumor necrosis factor-alpha drugs, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, fiber, and probiotics within two weeks prior to the intervention, pregnancy and lactation, as well as any diseases that may confound the results.

Intervention group: They will receive two 500 (gdu) capsules containing bromelain manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks. Control group: They will receive two 500 mg capsules containing maltodextrin manufactured by Salamat Parmon Amin Pharmaceutical Company 1 hour before or 2 hours after food for 8 weeks.

Ulcerative colitis and Crohn's disease activity and Quality of life in inflammatory bowel disease

Due to the high costs of measuring fecal calprotectin, the lack of necessary cooperation by laboratories, and the few laboratories that measure the aforementioned factor, and considering that this factor was not the main outcome of the present study and the sample size was not calculated accordingly, with the opinion of the respected professors of the Nutrition Department and receipt of research approval, as well as adjustment of the study entry and exit criteria with the opinion of the respected consulting physician, this update is required to fully align the information with the updated version of the proposal in the Research Assistant system.

Patients meeting the study's inclusion criteria will be allocated to group A or B according to a randomized list generated by the Random Number Calculator software, based on the order of their enrollment. Coordination will be established with Salamat Parmoun Amin pharmaceutical company for the preparation of the placebo. The drug manufacturer will be requested to assign one of the letters (A or B) to the drug and the other to the placebo using a coin toss for randomization.

This interventional study will be conducted in a triple blind manner. Blinding includes patient, therapist and analyst. In order to make a placebo, coordination will be done with Salamat Parmon Amin production company and it is requested that the drug manufacturer put one of the letters A or B on the drug or placebo and the other letter on the other by using a lottery by throwing a coin. The confidentiality of both the drug and placebo types should be maintained until the conclusion of the data analysis, as a fundamental element of the research protocol, and after the analysis, the researcher will ask the person in charge of the drug manufacturing for the type of labels. This means that the therapist will not know the type of medicine or whether the medicine packages are placebo. Neither the patient nor the analyst will know about this. The placebo capsules will bear complete resemblance to the capsules of the intervention group in terms of their coating, color, and smell