Probiotics

11

Review clinical trials related to Probiotics. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma

The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.

Participants needed: 294
Trial details
Phase: Phase 4Age: 18-75Biological sex: AllType: InterventionalSponsor: The Affiliated Hospital of Qingdao UniversityUpdated: May 26, 2026Locations: 2
Eligibility criteria

Age between 18 and 75 years [+6]

Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior t... [+10]

Status: Recruiting

Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

This randomized controlled clinical trial aims to evaluate the effectiveness of adjunctive coenzyme Q10 and probiotic supplementation (Limosilactobacillus reuteri Prodentis®) in improving periodontal health in pregnant women undergoing non-surgical periodontal therapy. Forty participants will be randomly assigned to two groups: the test group will receive professional oral hygiene every three months along with a coenzyme Q10-based toothpaste and daily probiotic supplementation; the control group will follow the same protocol without probiotics. The primary outcome is the reduction of the Plaque Index (PI), while secondary outcomes include Bleeding on Probing (BoP), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), gingival inflammation (MGI, PMGI), plaque distribution (PCR%, API), and gingival recession (R). The study duration is 6 months. The goal is to assess whether this combined therapy can promote a balanced oral microbiota and enhance periodontal health during pregnancy.

Participants needed: 40
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of PaviaUpdated: Feb 20, 2026Locations: 1
Eligibility criteria

Pregnant women between the 4th and 8th month of gestation [+4]

Presence of cardiac pacemakers [+5]

Status: Recruiting

Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Objective: This study aims to evaluate the effectiveness of Bacillus coagulans in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Bacillus coagulans, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.

Participants needed: 180
Trial details
Phase: Phase 4Age: 18-80Biological sex: AllType: InterventionalSponsor: Xijing Hospital of Digestive DiseasesUpdated: Jan 5, 2026Locations: 1
Eligibility criteria

Patients diagnosed with functional dyspepsia (FD) according to the Rome IV crite... [+2]

Use of probiotics or antibiotics within one month prior to the trial. [+10]

Status: Recruiting

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.

Participants needed: 180
Trial details
Phase: Phase 4Age: 18-80Biological sex: AllType: InterventionalSponsor: Xijing Hospital of Digestive DiseasesUpdated: Jan 5, 2026Locations: 1
Eligibility criteria

Patients diagnosed with functional dyspepsia (FD) according to the Rome IV crite... [+2]

Use of probiotics or antibiotics within one month prior to the trial. [+10]

Status: Not yet recruiting

Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia

The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.

Participants needed: 100
Trial details
Phase: Phase 4Age: 19-79Biological sex: AllType: InterventionalSponsor: National Health Insurance Service Ilsan HospitalUpdated: May 25, 2025
Eligibility criteria

Adult patients aged 19 years or older admitted with a diagnosis of community-acq... [+1]

Sepsis patients [+7]

Status: Recruiting

The Effect of Survival, Response and Microbiota Change in Different Therapy Under Probiotic Supplement

Probiotics are a group of viable microorganisms including bacteria and yeasts that if consumed in sufficient amounts, may afford health benefits to the host. The major advantage of probiotic administration is its ability to maintain gut microbial homeostasis, reduce pathogenic microorganisms in the GI tract, and restores homeostasis of intestinal microorganisms. Moreover, by modulating microbiota and immune responses, decreasing bacterial translocation, promoting the function of the gut barrier, inducing anti- inflammatory properties, triggering anti-pathogenic activity, and decreasing tumor development and metastasis, probiotics might contribute to the prevention and treatment of GI cancers and lung cancer. Considering the potential roles of Helicobacter pylori (H. pylori) in the initiation of colorectal and gastric cancers, the possible properties of probiotics against GI neoplasm in humans have been investigated in relation to their suppressive effects on H. pylori. The gut microbiota also has proved to in the response and resistance to immunotherapy. By triggering immune activity, probiotics, as functional dietary supplements, may mitigate neoplastic predisposition and development of GI cancers. Clostridium butyricum is a spore-forming bacillus named for its capacity to produce high amounts of butyric acid and is found in soil. Clostridium butyricum MIYAIRI 588 strain (MIYA-BM) is widely used as probiotic therapy to improve symptoms related to dysbiosis such as constipation, nonantimicrobial diarrhea, and anti- microbial-associated diarrhea in Japan and China. Clostridium butyricum increases beneficial bacteria, especially lactobacilli and bifidobacteria. Bifidobacterium promotes antitumor immunity and facilitates efficacy of antitumor treatment. The antitumor treatments are differed to three types: immune checkpoint blockade, target therapy and chemotherapy. Thus, investigators hypothesized that probiotic Clostridium butyricum therapy (CBT) may enhance the therapeutic efficacy of anti-tumor therapy through the modulation of gut microbiota. Investigators will discuss the different kinds of anti-tumor effect in survival and response after probiotic supplement.

Participants needed: 120
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: Chang Gung Memorial HospitalUpdated: May 31, 2025Locations: 1
Eligibility criteria

age≧20 [+2]

age<20 [+1]

Status: Recruiting

The Role of Probiotics in the Treatment of Endometriosis (ProMetrioS): a Randomised Double-blinded Placebo-controlled Cross-over Trial

ProMetrioS is a randomised blinded placebo-controlled cross-over trial investigating the effect of specific multistrain probiotics in patients with endometriosis. The aim of this clinical trial is to determine whether probiotic treatment can significantly modulate gut microbiome composition and functionality in endometriosis patients, specifically parameters associated with the estrobolome.

Participants needed: 40
Trial details
Age: Up to 35Biological sex: FemaleType: InterventionalSponsor: The Gut Microbiome Center (Centar za crijevni mikrobiom)Updated: Apr 16, 2025Locations: 1
Eligibility criteria

adult subjects with stage III or IV endometriosis diagnosis confirmed by biopsy

Age > 35 years [+6]

Status: Recruiting

Probiotics in Advanced Urothelial Carcinoma

This is a multicenter, randomized, controlled phase II Study of evaluating the efficacy and safety of immunotherapy combined with probiotics compound (Biolosion) in patients with advanced urothelial carcinoma.

Participants needed: 222
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Apr 1, 2025Locations: 3
Eligibility criteria

Aged 18 or above; [+8]

Patients with locally advanced disease may receive local radical treatment; [+17]

Status: Not yet recruiting

Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients

This study aims to investigate the impact of probiotics and synbiotics on the nutritional status of patients with end-stage kidney disease (ESRD) who are undergoing hemodialysis. ESRD patients often face challenges such as poor nutritional status, increased risk of infections, and imbalances in gut microbiota. These challenges are made worse by the frequent use of medications, dietary restrictions, and the hemodialysis process itself, which can disturb the gut's natural bacteria balance. Probiotics are live microorganisms that provide health benefits when taken in adequate amounts, while synbiotics are a combination of probiotics and prebiotics (substances that promote the growth of beneficial bacteria). The goal of this study is to explore whether supplementing ESRD patients with probiotics or synbiotics can improve their nutritional health, including aspects like body mass index (BMI), skin fold thickness, and protein metabolism. The study will involve 60 patients from a hemodialysis center in Mansoura, Egypt. Patients will be randomly assigned to one of three groups: one group will receive probiotics, another will receive synbiotics, and the third group will act as a control (no treatment). The study will evaluate changes in nutritional markers and other health parameters before and after six months of supplementation. This study hopes to provide insights into new, cost-effective interventions for improving the health of patients undergoing long-term dialysis treatment by addressing the question of whether these supplements can improve the nutritional status of hemodialysis patients.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Mansoura UniversityUpdated: Mar 24, 2025
Eligibility criteria

Patients with End-Stage Renal Disease (ESRD) on regular hemodialysis (3 times pe... [+3]

Patients who are actively preparing for kidney transplantation. [+5]

Status: Recruiting

Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are: 1. Can NASH be treated by altering the gut microbiota using LFMT capsules? 2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT? 3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH? Participants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.

Participants needed: 48
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Updated: Aug 27, 2024Locations: 1
Eligibility criteria

biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score... [+2]

Current or history of significant alcohol consumption for a period of more than... [+23]

Status: Not yet recruiting

Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy

The goal of this clinical trial is to evaluate the efficacy and safety of probiotics combined with enteric-coated budesonide capsule in patients with IgA nephropathy on the basis of optimized RAS blockade therapy, and to explore the correlation between the efficacy of probiotics combined with enteric-coated budesonide capsule in the treatment of primary IgA nephropathy and intestinal homeostasis. The main questions it aims to answer are: Dose probiotics combined with enteric-coated budesonide capsule provide a durable reduction in urine protein creatinine ratio (UPCR) in participants, compared with probiotics placebo combined with enteric-coated budesonide capsule? What medical problems do participants have when taking probiotics combined with enteric-coated budesonide capsule? Participants will: Take probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules every day for 9.5 month Participate in center site follow-up visits for 13 times Keep a diary of their symptoms and outcomes

Participants needed: 206
Trial details
Phase: Phase 4Age: 18-70Biological sex: AllType: InterventionalSponsor: Gang XuUpdated: Jul 30, 2024Locations: 1
Eligibility criteria

Adult age: 18~70 years old; [+5]

Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis; [+21]