Comparing the effects of probiotic supplementation and placebo on clinical status and metabolic profiles in overweight or obese women with fibrocystic changes of breast

The aim of this study is to determine the effects of probiotic supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic changes of breast

Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive probiotic supplements (n=34) or placebo (n=34).

Among women with fibrocystic changes of breast who are referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 68 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. intervention period: 12 weeks

Inclusion criteria: Patients aged 18-45 years diagnosed with fibrocystic breast disease, having moderate or severe cyclic mastalgia, BMI ≥ 25. Exclusion criteria: Malignant breast diseases, taking medicines for reducing pain (such as danazol, tamoxifen, bromocriptine) over the past three months, menopause women, pregnant or breastfeeding women, psychological diseases, Unwillingness to cooperate

Intervention group: Probiotic capsule (Zisttakhmir Co., Tehran, Iran), including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum, once a day for 12 weeks orally. Control group: Placebo capsules (Zisttakhmir Co., Tehran, Iran), once a day for 12 weeks orally.

hs-CRP (primary outcome) and Breast Pain Severity, biomarkers of oxidative stress, parameters of mental health, glucose and lipid metabolism indices (secondary outcomes)

Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 68 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the general surgery clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Zisttakhmir pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.