Clinical Research Directory

Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer

To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer

Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis

Does the administration of the probiotic Lactobacillus plantarum sp. have an impact on reducing leukocyte levels, segmented neutrophil counts, postoperative pain, and length of hospitalization in patients with diffuse peritonitis caused by perforated acute appendicitis who underwent laparotomy appendectomy at Dr. Hasan Sadikin Hospital?

Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes

The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes.

Probiotics, Antibiotics and the Post-Antibiotic Microbiota

Antibiotic therapy can cause gastrointestinal dysbiosis and this study will assess the impact of probiotic supplementation on microbiological composition and functionality pre- and post- antibiotic therapy

Efficacy of Symprove Probiotics in Coeliac Disease

Coeliac Disease (CD) is a lifelong autoimmune condition where eating gluten (a protein found in wheat, barley, and rye) causes damage to the small intestine. It affects around 1 in 100 people. Most individuals feel better and their gut heals after switching to a strict gluten-free diet. However, up to 1 in 5 people with coeliac disease continue to experience unpleasant gut symptoms-such as bloating, pain, and diarrhoea-despite following the diet and having a healed intestine. These ongoing symptoms can be very distressing and impact daily life. This study investigates whether a food supplement called Symprove, a probiotic drink containing live good bacteria, can help relieve these ongoing symptoms. Scientists believe that in some people with coeliac disease, the community of bacteria in the gut (called the microbiota) becomes unbalanced, even after going gluten-free. This imbalance (known as dysbiosis) may lead to inflammation, irritation, and symptoms similar to irritable bowel syndrome (IBS). The aim of this study is to test whether Symprove can help correct this imbalance and reduce symptoms. Participants will take Symprove daily and their symptoms, quality of life, and gut bacteria (measured from stool samples) will be monitored over time. The study hopes to answer three key questions: Can Symprove reduce gut symptoms in people with coeliac disease who are in remission? Does it work by restoring a healthy balance of gut bacteria? Are people with more severe imbalance (dysbiosis) more likely to have symptoms? If successful, this research could offer a safe, non-drug option to improve life for coeliac patients who continue to suffer symptoms despite avoiding gluten. It could also help suggest that gut bacteria play a role in ongoing symptoms and are a target for future treatment.

Probiotics in COPD: Effects on Symptoms, Lung Function, and Inflammation

The goal of this randomized, placebo controlled, double-blind clinical trial is to find out whether a probiotic supplement can help adults with chronic obstructive pulmonary disease (COPD) breathe better and better control their symptoms. The study will try to answer does taking a probiotic supplement, compare with a placebo, reduce shortness of breath, does it improve daily COPD symptoms or change stool patterns by using validated questionnaires; does it affect lung function or inflammation. The results of this study may contribute to a better understanding of the disease, the application of new therapeutic options, and provide a foundation for future research.

The Effect of Probiotic Supplementation on the Exercise Performance of Long-distance Runners.

The study is designed as a randomized double-blind placebo-controlled clinical trial with a 4-week probiotics intervention period. The study will be conducted between January 2022 and March 2025 at the Medical University of Gdańsk, Department of Bioenergetics and Physiology of Exercise (Gdańsk, Poland). A total of 40 endurance-trained adult men, specifically long-distance runners with previous experience in marathon races, will be enrolled. Only participants who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. Participants will be randomly assigned to the probiotic (PRO) or placebo (PL) group in a 1:1 ratio. Athletes will supplement 4 capsules of the study product (probiotic mixture) daily. To eliminate the effect of diet on the gut microbiome, all athletes will receive an individually balanced box diet designed to provide 100% of energy requirements, protein intake of 1.6 g/kg/day, and at least 8 g/kg/day of carbohydrates. Participants will continue their training programs and perform at least 5 endurance workouts per week. To assess training loads, athletes will report average pulse range, subjective fatigue, and duration of training sessions. The investigators will examine whether 4 weeks of probiotic supplementation in conjunction with a personalized diet may have a direct or indirect influence on sport performance. This will be assessed through evaluation of aerobic fitness capacity using treadmill tests. The cardiopulmonary exercise test (CPET) will determine maximum oxygen uptake, minute lung ventilation, and heart rate. Body composition analysis and assessments of blood and fecal samples will also be performed. Blood samples will be analyzed for serum pro-inflammatory cytokines (IL-6 and TNF-α). Collected fecal samples will be subjected to quantitative and qualitative analysis of the intestinal microbiota using next-generation sequencing. The analysis will include intestinal permeability markers (calprotectin, zonulin, IFABP) and bacterial metabolism products such as short-chain fatty acids (SCFA). All assessments and procedures will be carried out both before and immediately after the supplementation period. All obtained data will undergo statistical analysis. Descriptive statistics will be used for background information and to examine trends in the analyzed parameters, with mean values and 95% confidence intervals. Depending on the distribution of the data, parametric or non-parametric tests will be applied. Statistical significance will be set at p \< 0.05. To the best of the investigators' knowledge, this will be the first intervention study comprehensively assessing the influence of probiotic supplementation in conjunction with a standardized diet on inflammatory response, intestinal permeability, gut microbiome composition, and aerobic capacity of competitive long-distance runners. The collected data will provide evidence regarding the potential influence of probiotic supplementation on parameters of sport performance.

Probiotics for Women

Investigation into the effect of probiotic supplementation on the wellbeing of women with a history of vaginal discomfort and/or irritation, along with any microbiome changes.

Probiotic-Based Versus Ethyl Lauroyl Arginate-Containing Mouthwashes on Streptococcus Mutans Counts, Dental Plaque Accumulation, and Salivary pH in a Group of Egyptian School Children

This study aims to compare the efficacy of probiotic-based mouthwashes versus ethyl lauroyl arginate-containing mouthwashes in reducing Streptococcus mutans count, dental plaque accumulation, and salivary pH among a group of Egyptian schoolchildren.

Multi-strain Probiotic Effects on Self-Reported Constipation

Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g. increasing fibre intake, hydration, levels of exercise), medical therapies are available for management. However, a sizeable number of sufferers are dissatisfied with drug treatments (either over-the-counter or prescribed), meaning there is an unmet need for alternative therapeutic strategies. Pre, pro- and synbiotics have emerged as one alternative treatment, and a growing body of evidence now supports their use in a proportion of individuals with mild constipation. However, it is currently not possible to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment. The multistrain live bacterial food product (probiotic) being tested contains billions of live and active bacteria that has been shown to improve symptoms in the irritable bowel syndrome (IBS: which is 'constipation-predominant' in many). Notably, improvements ('completely resolved' or 'some positive difference') in bowel habit satisfaction, abdominal pain, bloating and urgency, as well as on quality of life have been shown after 4 or more weeks of this probiotc. This study aims to have 20 participants with self-reported constipation to assess improvements in constipation symptoms, quality of life and measures of gut function.

Probiotics and Active Aging: Enhancing Gut Health

The general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. By making use of available resources and fostering collaboration among the elements involved in the study, more specific objectives can be defined: 1. To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota. 2. To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults. 3. To evaluate the effects of the intestinal microbiota in older adults participating in a training programme. 4. To assess the physical fitness and perceived quality of life in older adults who engage in sport activities supported by technology. Participants will: * Perform physical tests such as the 6-Minute Walk Test (6MWT), the Timed Up and Go (TUG), and the Sit-to-Stand test. * Complete wellbeing questionnaires to assess their perceived quality of life and health status. * Complete dietary habit questionnaires. * Provide stool samples for microbiota analysis. * Take part in exercise interventions or placebo exercise sessions, depending on their assigned group.

Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

To evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) Methods: Clinical efficacy evaluation of TMS combined with Live Probiotic tablet for chronic diarrhea in IBS patients. The 400 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live), rTMS combined placebo, shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) and shamrTMS combined placebo group. Corresponding treatment was given for 2 week, rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Clinical assessment included symptoms, stool traits, mood, and sleep. 2\. Study on the mechanism of using intestinal flora data to evaluate the treatment of chronic diarrhea in IBS patients. 30 cases each were included in the 4 groups of IBS-eligible patients, and repeated transcranial magnetic stimulation treatment was given to the patient group for 2 week, and the patient group underwent the assessment of investigating the quantity and metabolic changes of the intestinal flora in feces before and after the treatment.

Probiotics for Preterm Infants

Probiotics will be used for preterm infants under 32 weeks of gestation and under 1500 g birthweight. Our aim was to investigate the effects of probiotics for stable preterm infants after extubation and who reached full enteral feeding. There are some hesitations among care-givers to start probiotics early due to safety issues although there are many positive effects of these products reported int the literature.

Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis

The primary goal of this study is to determine the effects of oral probiotics on the severity of ocular symptoms and the alterations of the gut microbiome of children (4-18 years old) with vernal keratoconjunctivitis. The current study will also assess the safety of oral probiotics among children with vernal keratoconjunctivitis. The main questions it aims to answer: 1- Does treatment with oral probiotics improve the severity of ocular symptoms in children with vernal keratoconjunctivitis? 2- Does treatment with oral probiotics alter the gut microbiome of children with vernal keratoconjunctivitis? Researchers will compare the ocular symptoms and gut microbiome between two groups receiving oral probiotics and placebo among children with vernal keratoconjunctivitis. Participants The participants will receive the oral probiotics and placebo ever day for one month. Record their regimen and keep a diary of their symptoms.

Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery

This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.

Effects of LP28 on Immunity Enhancement in the Elderly

Due to the increasing attention on aging-related health issues, this study focuses on the elderly population as participants. The aim is to investigate whether supplementation with Lactobacillus plantarum LP28 can effectively enhance immunity, reduce the frequency and severity of common cold infections, and ultimately promote overall health in the elderly.

Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Probiotics might be of help in preventing dysbiosis and emergence of SIBO. Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475; the first have extensive data supporting its use in gastric infections (18) however, it lacks the anti-inflammatory properties that have been provided by L. Reuteri DSM ATCC PTA 6475 that has excellent acid resistance and has strong anti-inflammatory properties (19); for these reasons, Gastrus is the best candidate for this indication.

Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease

Rapid eye movement sleep behavior disorder (RBD) is important non-movement feature, and also the important risk factor of Parkinson's disease (PD). In our previous work, we found that the movement features and RBD of PD patients improved after taking probiotics. The later was not reported before and the mechanism not clear. To investigate its role and mechanism, we plan to enroll patients of PD-RBD, idiopathic RBD, and healthy control, collect data of multimodal image technology before and after probiotic treatment，including resting state functional MRI，1H-MRS，123I-MIBG; analyze these data with clinical features, including UPDRS -III score, RBD-HK score , as well as the bacteria abundance and level of glutamate，GABA in blood and stool. Then, construct PD mouse model by fecal transplantation of PD patient, give or not give mouse probiotics treatment, and detect the level of glutamate, GABA, and so on, as well as α-synuclein of each brain area of each group, to explore the role and mechanism of probiotics in improving RBD and movement disorder of PD.

Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding

The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.

A Randomised-controlled Trial of an Oral Microbiome Immunity Formula in Recovered COVID-19 Patients

This study aims to evaluate the effectiveness of an oral microbiome immunity formula in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities in patients who have recovered from COVID-19.