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Mastitis clinical trials

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NCT ID: NCT05852171 Recruiting - Clinical trials for Idiopathic Granulomatous Mastitis

Baricitinib in Idiopathic Granulomatous Mastitis

Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

This study will explore the mechanism of targeted drug in treatment of idiopathic granulomatous mastitis, and clarify the clinical classification and corresponding markers.

NCT ID: NCT05794945 Recruiting - Mastitis Postpartum Clinical Trials

Optimizing Mastitis Identification and Treatment

OPTIMIST
Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to gain more information about the aetiology and progression of mastitis and breast inflammation, in order to develop evidence-based clinical guidelines and treatment plans, especially concerning judicious use of antibiotics. The main questions it aims to answer are: - Do clinical symptoms differ between inflammatory and infectious mastitis? - What is the microbial composition in human milk, and does it change before, during, and after episodes of mastitis? - Does the bacterial composition change due to antibiotic treatment? - Are all mastitis episodes treated with antibiotics bacterial mastitis? - Do mothers with recurrent mastitis have a distinct microbial composition? - Are there immunological markers that can differentiate between bacterial and inflammatory mastitis? Researchers will compare breastfeeding women with and without mastitis to see if the microbiological composition in milk and on the skin of the breast and breast nipple differs.

NCT ID: NCT05530226 Recruiting - Clinical trials for Plasma Cell Mastitis

A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis

Start date: October 1, 2021
Phase: Phase 2
Study type: Interventional

This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.

NCT ID: NCT05361629 Recruiting - Clinical trials for Idiopathic Granulomatous Mastitis

Idiopathic Granulomatous Mastitis Combination Therapy

IGM-COMBO
Start date: April 16, 2022
Phase: N/A
Study type: Interventional

After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means. Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.

NCT ID: NCT05281419 Recruiting - Clinical trials for Refractory Granulomatous Lobular Mastitis

Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Granulomatous lobular mastitis (GLM) is a rare, chronic benign inflammatory disease of the breast, of unknown etiology. Pathologically, GLM typically manifests as non-caseating granulomatous lesions with leukomonocytes, lymphocytes, neutrophils and multinucleated giant cells, located in the center of breast lobules. With a rapidly increasing morbidity in the last two decades, GLM tends to occur in child-bearing women with a prolonged and recurrent course. Intralesional injection and topical corticosteroids can effectively reduce the side effects, especially in patients suffering from concomitant skin lesions (e.g., fistula, skin erosions, ulcers).For patients with diffuse disease, recurrence, or ineffective conservative treatment, wide local excision can be applied.

NCT ID: NCT05207241 Recruiting - Lactation Mastitis Clinical Trials

The Effect of Gravity on the Occurrence of Lactational Mastitis

Start date: January 1, 2022
Phase:
Study type: Observational

Lactation is the instinct of almost all mammals, including human beings. With the development of human society, the function of lactation has gradually deviated from nature instinct. Breastfeeding related industries, such as milk bottles, formula and breast pumps, have formed a vast consumer market, leading to a transition from breastfeeding mothers' individual instinct to the social division of labor. Previous studies found that the incidence of lactational mastitis remains largely unchanged post World War II with some reporting an increase, suggesting the hazards of lactational mastitis still exist under the background of social division of labor. Breast milk contains ingredients that improve the immunity of newborns. By affecting mothers' breastfeeding, lactational mastitis pose a hazard for newborns, increasing the chances of developing respiratory and gastrointestinal diseases. For breastfeeding mothers, severe mastitis may develop into breast abscess due to improper treatment in the early stage. In addition to antibiotic treatment, incision, drainage and even surgery may be required. These potentially increase the risk of developing postpartum depression, type II diabetes, breast cancer and ovarian cancer. Compared with other mammals, humans and cows have a higher incidence of lactational mastitis, indicating that human intervention in breastfeeding may be the cause of the high incidence. On the other hand, as a result of walking upright, humans' hands are liberated, forming complex and diverse breastfeeding position. According to the Sakra World Hospital, these positions are classified into eight types: cradle, cross cradle, supine, football, Australian hold, inverted lateral, lateral cradle, and lateral. The pilot study demonstrated that different breastfeeding positions are closed related to the occurrence of lactational mastitis, and to the location of mastitis. Assuming that the baby's sucking factors remain the same, there must be differences in the milk drainage in different breastfeeding positions under the influence of gravity. Researchist speculate that breastfeeding women who opt to a position that cause an anti-gravitational expulsion of milk are more likely to develop lactational mastitis. Therefore, this study aims to investigate how the scientific guidance on the gravitationally assisted breastfeeding positions will reduce the occurrence of mastitis.

NCT ID: NCT05132426 Recruiting - Mastitis Clinical Trials

Osteopathic Manipulative Treatment for Recurrent Mastitis

Start date: October 29, 2021
Phase: N/A
Study type: Interventional

This study will investigate whether Osteopathic Manipulative Treatment (OMT) is effective in treating recurrent mastitis without the use of antibiotics and if it helps in preventing future recurrence of mastitis in individuals who have had multiple occurrences of mastitis.

NCT ID: NCT05051215 Recruiting - Microbiota Clinical Trials

Gut Microbiota and Nonpuerperal Mastitis

Start date: August 15, 2021
Phase:
Study type: Observational

Nonpuerperal mastitis (NPM), mainly including Plasma cell mastitis (PCM) and Granulomatous mastitis (GM), which clinical presentation is an accessible and painful breast mass accompanied by skin redness and swelling, nipple retraction and fistula formation . Much progress has been made in exploring the etiology and pathogenesis of NPM, while the exact etiology remains unknown, NPM is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. While microbiota as an environment factor to some inflammatory and autoimmune diseases accept widespread attention, if gut microbiota also as a risk factor for NPM, it is worthy to be considered.

NCT ID: NCT05021042 Recruiting - Breast Feeding Clinical Trials

Identification of Biomarkers of Mastitis

Start date: May 1, 2021
Phase:
Study type: Observational

Breastfeeding is the optimal feeding for infants. WHO currently promotes breastfeeding and recommends it to be exclusive until the baby is 6 months old. Breastfeeding has a positive impact on both the mother's and the infant's health and is directly associated with the decrease in diseases such as cancer, diabetes, cardiovascular disease, and inflammatory and infectious diseases. Currently, in Spain, only 39% of infants at 6 months are breastfed. The factors that influence the abandonment of breastfeeding are returning to work, the sensation of hypogalactia, problems to breastfeed, and breast complications, like mastitis, being the pain its main cause. Recent studies have associated pain while breastfeeding with mammary gland inflammation (mastitis) caused by dysbiosis. In order to increase breastfeeding rates, it is necessary to find factors related to the progression of mastitis in breastfeeding women. In this context, the discovery of predictive biomarkers based on metabolic markers is key to act before or at the beginning of the progression of mastitis and thus reduce the rates of abandonment of breastfeeding due to pain. The present project aims to identify and validate metabolic biomarkers capable of predicting mastitis. For this purpose, a prospective observational case-control hypothesis-free study will be carried out in order to identify and validate biomarkers of mastitis in breastfeeding women. The study will be performed in two phases: the discovery of the possible biomarkers and the validation of the biomarkers. Breast milk will be collected at the beginning of the study and when women present symptoms compatible with mastitis. The presence or not of mastitis will be confirmed with a milk culture. Milk samples will be analyzed using non-targeted metabolomics approach. Using multivariate statistical models, the potential metabolites capable of discriminating the presence of mastitis in maternal milk will be identified. Later, these potential markers will be validated in independent samples.

NCT ID: NCT04637711 Recruiting - Clinical trials for Refractory Granulomatous Lobular Mastitis

Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Granulomatous lobular mastitis (GLM) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. Nowadays, in China, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. Empirical lesion resection is generally used. We believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. Because GLM is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. In order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". The purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients, and standardize GLM surgical schemes.