Clinical trials

Helicobacter pylori (H. pylori) is a very common gastrointestinal disease that colonises the human gastric mucosa and is a primary risk factor for chronic gastritis, peptic ulcer disease, and gastric cancer. The standard first-line treatment for H. pylori eradication is bismuth-containing quadruple therapy. While effective, this aggressive, multi-antibiotic regimen frequently induces significant gastrointestinal adverse effects and severe disruption of the normal gut microbiota (dysbiosis). These side effects often lead to poor patient compliance, which in turn contributes to treatment failure and the increasing global challenge of antibiotic resistance. Emerging clinical evidence strongly supports the use of probiotics as an adjuvant therapy to alleviate antibiotic-associated side effects and significantly aid in restoring intestinal balance. Spore-forming Bacillus species, specifically Bacillus clausii, Bacillus subtilis, and Bacillus coagulans, are particularly advantageous due to their natural resistance to acidic gastric conditions and concurrent antibiotic administration, allowing them to remain viable and active during the intensive eradication therapy. This clinical trial is designed as a randomised, double-blind, placebo-controlled study to evaluate the clinical efficacy, adverse effects, and treatment adherence of a standard four-drug bismuth-containing regimen for the treatment of H. pylori infection when combined with single-strain and multi-strain Bacillus probiotics. The trial is conducted in the Gastroenterology Department of Tam Anh Hospital. 336 participants diagnosed with H. pylori infection and prescribed the standard 14-day bismuth-containing quadruple therapy are randomly divided and allocated to receive either a single-strain probiotic (LiveSpo Clausy), a multi-strain probiotic (LiveSpo DIA 30), or an identical placebo. Over 8 weeks of follow-up, participants will be assessed at predefined time points for antibiotic-associated adverse events, gastrointestinal symptoms, stool form, treatment adherence, and Helicobacter pylori eradication status. Stool samples will be collected before and after treatment to evaluate faecal IgA levels, the presence of Bacillus strains, and changes in gut microbiota using real-time PCR, ELISA, and 16S rRNA sequencing.

Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis. Although current therapies can control inflammation, many patients still experience recurrent symptoms, treatment resistance, adverse effects, and impaired quality of life. Probiotics represent a promising adjunctive approach for IBD by restoring gut microbial balance, modulating mucosal immunity, supporting intestinal barrier function, and potentially improving symptoms while reducing unnecessary reliance on antibiotics or intensive treatments. In this study, researchers propose that oral supplementation with multi-strain Bacillus spore probiotics, when used in combination with standard IBD treatment, is safe and may provide additional clinical benefits by improving gastrointestinal symptoms, quality of life, and disease activity in patients with IBD. The objective of this study is to evaluate the safety and efficacy of Bacillus spore probiotics, including LiveSpo® COLON and LiveSpo® DIA30, in patients with inflammatory bowel disease. LiveSpo® COLON contains Bacillus subtilis ANA3 and Bacillus clausii ANA39 at a concentration of 3 × 10⁹ CFU/5 mL, while LiveSpo® DIA30 contains Bacillus subtilis ANA48, Bacillus clausii ANA39, and Bacillus coagulans ANA40 at a concentration of 5 × 10⁹ CFU/5 mL. Study Design: * Sample Size: 150 participants * Study Location: Department of Gastroenterology Intervention Description: A total of 150 eligible participants will be randomly assigned to three groups (n = per group). * The Placebo Group will receive standard IBD treatment combined with oral RO water, one ampoule per dose, three times daily for 30 consecutive days. * The COLON Group will receive standard IBD treatment combined with LiveSpo® COLON, one ampoule per dose, three times daily for 30 consecutive days * The DIA30-COLON Group will receive standard IBD treatment combined with LiveSpo® DIA30, one ampoule per dose, three times daily for the first 14 days, followed by LiveSpo® COLON, one ampoule per dose, three times daily for the next 16 days. All participants in the three groups will receive blinded, coded study products. Patients in all groups will follow the standard IBD treatment regimen of the hospital and use the assigned study products throughout the study period. Caregivers or clinical staff will monitor the health status of participants and record relevant information in their medical records. During the study, participants will be instructed not to use any additional probiotic products or solutions containing similar components. Study Duration: 12 months.

The main questions this study aims to answer are: * Does using probiotic nasal spray (LiveSpo Navax containing Bacillus subtilis and Bacillus clausii, 1x10\^9 CFU/mL), with or without oral probiotics (LiveSpo Pregmom containing Bacillus subtilis, Bacillus clausii, and Bacillus coagulans, 3x10\^9 CFU/5 mL), help children recover better from pneumonia when added to standard medical treatment? * Does using these adjunctive probiotics support reduce the recurrence of respiratory and gastrointestinal symptoms after hospital discharge? Researchers will compare three groups of children to see whether probiotic nasal spray alone or probiotic nasal spray combined with oral probiotics works better than placebo. All participants will receive standard medical treatment for pneumonia. In addition, they will be randomly assigned to one of three study groups to receive adjunctive probiotic support in 2 months: * Control group: receives a saline nasal-throat spray (0.9% NaCl) and oral placebo liquid (RO water). * Nasal probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray and oral placebo liquid (RO water). * Nasal plus oral probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray plus LiveSpo® Preg-Mom oral probiotic suspension. Participants will: * Use a nasal-throat spray three times a day. * Take an oral liquid twice daily. * Start using the study products during their hospital stay and continue for 8 weeks (2 months) from admission. * Be followed by the study team during hospitalization and at Day 30 and Day 60 after admission. The probiotic and placebo products look, smell, and taste the same so that neither the parents nor the study staff know which product each child receives.

Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and increased Proteobacteria. This early microbial alteration has been associated with functional gastrointestinal disorders (FGIDs), including colic, regurgitation, and changes in stool frequency and consistency, which may in turn affect early growth and overall gastrointestinal functioning. Probiotic supplementation is considered a safe and feasible strategy to support microbial restoration and improve digestive function during the first months of life. In this study, researchers propose that daily supplementation with multi-strain Bacillus spore probiotics may help support healthy early growth, reduce functional gastrointestinal symptoms, and promote a more balanced gut microbiota in cesarean-delivered infants. The objective of this study is to evaluate the safety and efficacy of two oral probiotic formulations, LiveSpo PREG-MOM and LiveSpo CONSY, containing multi-strain B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40 at respective 3 and 4 billion colony-forming units (CFU)/5 mL ampoule, administered 1 ampoule daily, during the first 90 days of life. The study examines effects on growth, digestive symptoms, immune markers, and microbial composition. Study Design: This randomized, blind, controlled clinical trial will enroll 180 healthy full-term cesarean-born infants at Hanoi Obstetrics and Gynecology Hospital. Intervention Description: Participants will be randomly assigned to three groups (n = 60 each). All groups will receive one 5-mL ampoule daily for 90 days: LiveSpo PREG-MOM, LiveSpo CONSY, or placebo. Stool samples will be collected at several follow-up time points to assess digestive health and microbial development. All products will be provided in blinded and coded packaging to maintain objectivity. Study Duration: 12 months

Despite advances in oral health care, cavities remain highly prevalent worldwide, especially among children. Conventional treatment methods focus on removing damaged tooth tissue but fail to completely eliminate or control pathogenic bacteria in the oral cavity, leading to a high risk of caries recurrence in the same or adjacent teeth. Probiotics are a promising biological therapy that can help restore balance in the oral microbiome. Among probiotics, Bacillus species are unique because they form spores that make them stable under harsh conditions, such as heat and storage. They can also produce enzymes and natural compounds with antibacterial, anti-inflammatory, and protective effects. These features make Bacillus probiotics strong candidates for oral health applications. This study is designed to evaluate the safety and efficacy of an oral-spray probiotic containing Bacillus subtilis ANA48 and Bacillus clausii ANA39 (LiveSpo® Smile CARE) in preventing and supporting the treatment of tooth decay in children. We hypothesize that this probiotic spray, when used regularly, will be safe and well-tolerated, while effectively reducing harmful bacteria in the mouth, preventing the progression of cavities, and improving overall oral health. Study Design: * Sample Size: 130 participants * Study Location: a primary school in Hanoi, Vietnam Intervention Description: A total of 130 eligible participants will be randomly assigned to two groups (n = 65 per group). Placebo Group will receive a 0.9% NaCl physiological saline, spray twice daily (morning and afternoon). Each application consists of two sprays at three sites (both dental arches and the front teeth), for a total of six sprays per use, continued for three consecutive months. Smile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU/mL × 20 mL of Bacillus subtilis and Bacillus clausii (LiveSpo Smile CARE). The dosage, frequency, and duration of use will be the same as in the placebo group. All participants will receive the same standard dental care throughout the study, including the use of identical toothpaste, supervised weekly fluoride rinsing with 0.2% sodium fluoride (NaF), and scheduled follow-up visits. The probiotic and placebo sprays will be packaged in blinded bottles and administered according to the study protocol to maintain objectivity. Study Duration: 12-18 months

Periodontal diseases are strongly associated with dysbiosis of the oral microbiome within the biofilm. Key pathogens, including Streptococcus mutans, Aggregatibacter actinomycetemcomitans, and Porphyromonas gingivalis, contribute to caries progression and periodontal inflammation. Given the limitations of antibiotic use and their potential side effects, probiotics represent a promising biological approach to restore microbial balance and support oral health. In this study, researchers propose that direct application of probiotic spray into the oral cavity is safe and effective in alleviating typical symptoms of periodontal disease, particularly by reducing pathogenic bacterial density. The objective of this study is to evaluate the safety and efficacy of a oral-spray Bacillus spore probiotics (LiveSpo Smile CARE), containing Bacillus subtilis ANA48 and Bacillus clausii ANA39 at a concentration of ≥ 1 billion CFU/mL x 20 mL formulation, for the prevention and supportive treatment of periodontal disease. Study Design: * Sample Size: 90 participants * Study Location: an elderly care center in Hanoi, Vietnam Intervention Description: A total of 90 eligible participants will be randomly assigned to two groups (n = 45 per group). * The Placebo Group will receive 0.9% NaCl physiological saline, spray twice daily (afternoon and evening), with two sprays per application at three sites (both dental arches and the front teeth), totaling six sprays per use, for four consecutive weeks. * The Smile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU/mL × 20 mL of Bacillus subtilis and Bacillus clausii (LiveSpo Smile CARE), administered with the same dosage and frequency as the placebo group. All participants will receive blinded, coded spray bottles to ensure objectivity. Both groups will be instructed to use the same standardized toothpaste during the study period. Caregivers will monitor the health status of participants and record relevant information in their medical records. During the study, caregivers will be instructed not to provide any additional probiotic oral care products or the solution contains similar components. Study Duration: 12-18 months.