Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial

Abstract

Background: Irritable bowel syndrome (IBS) is one of the most frequent and recurrent gastrointestinal diseases. However, up to now, no pharmacological agent has been approved to treat IBS. Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS. Propolis is an herbal substance with a broad spectrum of antioxidants, anti-inflammatory, and prebiotic properties, which might exert beneficial effects to reduce the severity of IBS. The current clinical trial aims to evaluate the efficacy of propolis supplementation on IBS. Methods: This single-center, randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the effect of propolis supplementation in adult patients with IBS diagnosed with Rome IV criteria. Fifty-two eligible patients will randomly be allocated to receive a propolis tablet (450 mg, containing 100 mg polyphenol compounds) or identical placebo, twice daily for 6 weeks. The primary outcome of the trial is an improvement in IBS severity from baseline to the sixth week of intervention. The secondary outcomes include the change in weight, waist circumference, and IBS quality of life. We will use the paired sample t test or Mann-Whitney U test for the within-group comparison and independent sample t test or Wilcoxon rank-sum and chi-square test or Fisher's exact test for the between-group comparison. Besides, a multivariable-adjusted mean effect will be computed using the ANCOVA test.

Effects of propolis supplementation on irritable bowel syndrome with constipation (IBS‐C) and mixed (IBS‐M) stool pattern: A randomized, double‐blind clinical trial

“…The tablets were administered before lunch and dinner for 6 weeks. The optimal dosage of propolis (900 mg/day) was extracted from animal studies and its method is completely described in the published protocol article of this study (Miryan et al., 2020 ). Due to the similar mechanism of propolis and prebiotics and probiotics for intestinal microflora, a period of 6 weeks is adequate to boost intestinal microflora and/or GI symptoms in patients based on former studies (Basturk et al., 2016 ; Han et al., 2017 ).…”

Molecular and Cellular Mechanisms of Propolis and Its Polyphenolic Compounds against Cancer

“…However, most epidemiological studies demonstrated a protective effect of phytoestrogens from propolis in breast cancer [ 261 ], particularly in premenopausal women; although, the results are not consistent. Current data indicate that intake of propolis induces estrogenic activity and suggest that propolis is a valuable source of phytoestrogens [ 122 , 123 , 130 , 149 , 150 , 151 , 327 ]. According to Ge et al [ 309 ], gut microbiota can be used as a tumor marker and may ensure valuable insights into the pathophysiology of malignant tumors.…”

Effects of Propolis Supplementation on The Severity of Disease In Irritable Bowel Syndrome Subjects: A Randomized, Double-Blind Clinical Trial

“…The binary logistic regression was used to calculate the odds of achieving the main outcome with propolis supplementation in both crude and adjusted models. Further details of the study method are presented in the protocol article of this study (17).…”

“…The tablets were similar in color, shape, and packaging; and were administrated before lunch and dinner for six weeks. The optimal dosage of propolis (900mg/day) was extracted from animal studies which its method is completely described in the published protocol article of this study (17). Due to the same mechanism of propolis and pre-and probiotics for intestinal micro ora, a period of six weeks is adequate to boost intestinal micro ora and/or GI symptoms in patients based on former studies (18,19).…”