The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol

Abstract

Introduction For many women, uncomfortable and stressful symptoms accompany the menstrual cycle each month, sometimes in a debilitating manner. Previous studies have reported that gastrointestinal symptoms in healthy women significantly differ by the day of the menstrual cycle, but few studies have assessed interventions intended to minimize these symptoms. Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations. This study evaluates the effect of a probiotic on abdominal pain and gastrointestinal symptoms in healthy women who take an oral contraceptive, have regular menses, and typically experience these symptoms during menstruation with the primary aim being change in abdominal pain intensity related to the menstrual cycle with probiotic versus placebo supplementation. Methods and analysis In this randomized, double-blind, placebo-controlled parallel study, participants will receive either a probiotic or placebo supplement. Participants will begin answering questionnaires approximately 7 days before the start of menstruation (i.e., active bleeding), and 3 days later, they will begin consuming the study supplement for 8 weeks. The questionnaires administered will collect data about abdominal pain severity (primary outcome) and duration related to the menstrual cycle, digestive health, dietary intake, stress, and digestion-associated quality-of-life. A subgroup of women will provide weekly vaginal swabs and stool samples to examine the effect of the probiotic supplement on microbiota composition and diversity for exploratory purposes. Two-sided tests using a linear model and a type I error rate of α = 0.05 will be employed to test all hypotheses. Continuous variables will be presented as means with standard errors and categorical variables, as counts or proportions. Ethics and dissemination This study was reviewed and approved by the University of Florida Institutional Review Board 01. Written informed consent will be obtained from all participants prior to any study activities. Study findings will be disseminated at scientific conferences and publication in the trial registry or in a peer-reviewed journal. Any protocol amendments will be reported in the final manuscript of this study. Trial registration ClinicalTrials.gov NCT04457401. Registered prospectively on 07 July 2020. The trial was completed in December of 2021. Protocol version V4.0 (11-04-2020) Trial status Currently recruiting. Recruitment began in November 2020 and extend until December 2021.

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“…Their use has gradually gained scientific acceptance, also in consideration of the widespread concerns linked to antibiotic resistance. Different probiotic formulations have been widely tested, for their potential effects on several gynaecological affections, including vaginal disease, endometriosis, miscarriage, preterm birth as well as gestational diabetes, and Polycystic ovary syndrome (PCOS) (26,(29)(30)(31)(32).…”

Gut microbiome influences incidence and outcomes of breast cancer by regulating levels and activity of steroid hormones in women

“…The severity of the uncomfortable and stressful gastrointestinal symptoms associated with menstruation, such as dysmenorrhea, abdominal pain, bloating, diarrhea and headache, vary with the menstrual phase each month 49 . These effects may be aggravated by consumption of oral contraceptives; but probiotics have been shown to alleviate the menstrual discomforts 50 . For instance, ingestion of Bifidobacterium has been shown to reduce gastrointestinal symptoms and abdominal pain 51 .…”

“… 49 These effects may be aggravated by consumption of oral contraceptives; but probiotics have been shown to alleviate the menstrual discomforts. 50 For instance, ingestion of Bifidobacterium has been shown to reduce gastrointestinal symptoms and abdominal pain. 51 Thus, microbiota composition and menstrual cycle, similar to other host responses, may have a strong association.…”