Overview:
Bacillus clausii is a probiotic that restores the good bacteria in the intestine that may be disrupted due to acute diarrhea, intestinal infections, or antibiotic use. Bacillus clausii is the commonly used species of Bacillus used as a probiotic. Its immunomodulatory and anti-microbial properties help prevent and treat intestinal bacterial flora disorders. Therefore, it is used particularly for treating acute and chronic diarrhea.
The other indications include the following:
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Prevention of infection in preterm neonates.
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Treatment of upper respiratory tract infections and nasal allergies in children.
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Small-intestine bacterial overgrowth (SIBO).
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Adverse effects of Helicobacter pylori treatment in adults.
Bacillus clausii is available as ready-to-consume mini bottles. The formulation is mostly safe and does not cause any side effects. However, rare side effects like angioedema, urticaria, and rashes can occur.
How Does Bacillus Clausii Work?
Bacillus clausii is a spore-forming bacterium. It works by inhibiting the growth of pathogens in the gastrointestinal tract, restoring intestinal flora balance. It also helps in producing vitamins, which helps treat dysvitaminosis.
What Are the Indications of Bacillus Clausii?
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Bacillus clausii is used in the management of alterations in the bacterial flora of the intestine. The spores help restore equilibrium lost due to diarrhea, antibiotic therapy, or chemotherapy.
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It is also indicated to correct dysvitaminosis; a state caused due to an imbalance in the production and assimilation of vitamins.
What Are the Contraindications of Bacillus Clausii?
It is contraindicated in patients with hypersensitivity to Bacillus clausii or its ingredients.
For Patients:
What Is Acute Diarrhea, and How Is It Managed?
Diarrhea is loose, watery stools with more frequent bowel movements. Acute diarrhea is sudden-onset diarrhea that does not last for more than one or two days. Diarrhea may sometimes be accompanied by nausea, vomiting, abdominal pain, and dehydration. It can occur due to various causes like viruses, bacteria, parasites, certain medications, lactose intolerance, sugars, fructose, and digestive disorders like irritable bowel syndrome, ulcerative colitis, small intestine bacterial overgrowth (SIBO), or celiac disease.
A stool test, breath test, blood work, or endoscopic evaluation help diagnose the cause of diarrhea. Most mild diarrheas can be managed at home with over-the-counter medications like Bismuth subsalicylate. However, if diarrhea persists for a more extended period, the doctor may prescribe medications like antibiotics, medicines for specific gastric causes, or probiotics. Probiotics include groups of good bacteria that are given to restore and replenish the normal microbiota of the intestine, that help in faster healing.
Patient Information:
How to Take Bacillus Clausii?
Bacillus clausii comes in small vials or bottles. The vial must be shaken, the cap twisted open, and the medicine must be consumed.
What Are the Available Dosages of Bacillus Clausii?
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For infants, one to two mini bottles per day, as advised by the doctor.
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For children, one to two mini bottles or one to two capsules per day, as advised.
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For adults, two to three mini bottles or capsules per day.
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Each pack contains ten mini bottles.
Can Bacillus Clausii Be Taken During Pregnancy and Lactation?
Yes, Bacillus clausii can be taken during pregnancy and lactation.
When Should Bacillus Clausii Not Be Used?
Patients with a history of hypersensitivity to the components of the medicine must avoid taking it.
What Happens When an Excessive Dose Is Taken?
Bacillus clausii does not cause any side effects when taken excessively. However, the dose recommended by the healthcare provider must be followed.
What Happens if a Dose Is Missed?
No side effects or reactions occur upon missing a dose. However, taking the daily dose as per schedule is recommended for better results.
What Are the Side Effects of Bacillus Clausii?
There are no significant side effects of Bacillus clausii. However, sometimes, the below side effects occur, which include:
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Urticaria (a rash due to an allergic reaction).
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Hypersensitivity reactions (due to the components of the medicine).
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Rashes.
What Are the Storage Requirements of Bacillus Clausii?
Bacillus clausii must be stored in a cool place. In addition, it must be kept out of reach of children.
Is Bacillus Clausii a Probiotic?
Yes, Bacillus clausii is a probiotic. It helps stimulate the development of healthy bacteria in the gut.
Can Bacillus Clausii Be Given to Both Children and Adults?
Bacillus clausii can be given to infants, children, and adults. However, the dosages in adults are slightly higher.
Dosage and Administration:
According to clinical studies, the typical dose of Bacillus clausii is 2×(10^9) spores (2 billion spores) administered orally as a suspension or capsule two to three times a day for ten days for up to three months.
The manufacturer's product information recommends 2 to 3 vials of suspension per day or 2 to 3 capsules per day in adults and 2×(10^9) to 4×(10^9) spores per day in the case of children and adults. The medicine is recommended only for short periods.
Dosing:
Bacillus clausii must be administered for a short period at regular intervals. When administered along with antibiotics, it must be administered in between the antibiotic doses.
Warnings and Precautions:
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During antibiotic therapy, Bacillus clausii must be administered between antibiotic doses.
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The medicine must be kept out of reach of children.
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A healthcare provider must be contacted if symptoms worsen two to three days after using the medicine.
Adverse Reactions:
In clinical studies, no adverse reactions have been reported with Bacillus clausii intake. Bacillus clausii was found to be relatively safe, even in low birth weight neonates and infants.
However, in 2014, the US FDA (United States Food and Drug Administration) warned about the potential risks of consuming dietary supplements containing live bacteria or yeasts in immunocompromised patients, including premature infants. With probiotics use, several cases of Bacillus clausii bacteremia were reported, out of which one was fatal. Almost all the reported cases were of immunocompromised patients or those with comorbidities. Also, there has been a case where an immunocompetent 17- month-old female with no prior history was affected.
For Doctors:
Drug Interactions:
Antibiotics can diminish the therapeutic effect of Bacillus clausii. Therefore, it is recommended to modify the therapy if necessary.
Uses of Bacillus Clausii:
Bacillus clasuii is indicated for use in the following conditions:
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Allergic Rhinitis: A pilot study was conducted on 20 children during the pollen season to evaluate the potential benefits of Bacillus clausii in relieving nasal symptoms, levels of eosinophils, and the use of antihistamines. All the children received an antihistamine (Levocetirizine) for symptomatic relief. Among 20, 10 were adjunctly given three vials of Bacillus clausii spores (2 billion spores per vial) along with the antihistamines. This group showed an improvement in nasal symptoms and eosinophils and required a lesser duration of antihistamine when compared to the group that did not receive Bacillus clausii.
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Cancer: The functional property that is of clinical interest regarding probiotic bacteria is antigenotoxicity. Though antigenotoxicity is considered strain-dependent, all 21 strains of Bacillus species exhibited genotoxicity to the same extent.
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Diarrhea: In 27 adult patients with acute diarrhea, a clinical phase 2 study was conducted to determine the antidiarrheal activity of Bacillus clausii. Acute diarrhea is three or more loose stools in 24 hours for longer than seven days. Administration of one capsule twice daily for ten days that contained 2 billion spores showed a significant improvement in the symptoms.
The mean duration of diarrhea reduced from 34.8 to 9.3 minutes per day, frequency from 6.96 to 1.78 times per day, stool consistency score from 3.93 (watery) to 1.22 (soft), and abdominal pain score from 3.22 (severe) to 0.74 (no pain). Stool analysis also revealed a resolution of occult blood and mild mucus, absence of previously detected fat, and red and white blood cells. In addition, Entameba histolytica cysts detected in the stools of three patients on the first day were eliminated by the end of treatment.
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Dysbiosis: Dysbiosis refers to antibiotic-associated diarrhea. Clinical and experimental studies conducted to determine the probiotic effect of Bacillus clausii in treating dysbiosis are yet to be studied. In addition, the ability to improve intestinal microbiota is yet to be established. Also, there is no sufficient evidence regarding treating pediatric diarrhea and eliminating Helicobacter pylori.
H.pylori Treatment-Induced Adverse Effects:
Helicobacter pylori treatment includes triple therapy with Clarithromycin, Amoxicillin, and Rabeprazole. In addition, adjunct therapy with Bacillus clausii was given during the seven-day course of treatment and the following seven days in 120 patients. It was studied that nausea and diarrhea were reduced to half, and epigastric pain was reduced significantly by the second week.
According to World Gastroenterology Organization guidelines, probiotics as an adjunct therapy helped in H.pylori elimination; however, there is no sufficient data regarding probiotic monotherapy as a potent eradication of H.pylori infection.
Infection:
Double-blind, randomized, placebo-control trials were conducted on 244 preterm infants to study the effects of probiotics in reducing the risk of late-onset sepsis. Bacillus clausii was administered till six weeks postnatal age. There was no difference noted in the incidence of probable and definite sepsis. However, with probiotic supplementation, full feeds were achieved faster.
Oral Health:
In patients with recurrent aphthous ulcers and oral candidiasis, application of Bacillus clausii twice daily for a week as an adjunct therapy showed a reduced degree of pain in aphthous ulcers patients and reduced burning sensation in oral candidiasis patients when followed up on day five. However, the size and number of aphthous ulcers were unaltered.
Small Intestinal Bacterial Overgrowth (SIBO):
The use of Bacillus clausii for SIBO decontamination was studied in 40 adults. They had symptoms like flatulence, bloating, abdominal pain and discomfort, diarrhea, and an abnormal hydrogen glucose breath test. They received Bacillus clausii therapy three times daily for a month. There was 47 % decontamination with the probiotic use. One patient reported constipation as an adverse effect.
Upper Respiratory Tract Infection:
A study was conducted on 80 children in the age group of three to six years who attended daycares. These children experienced recurrent respiratory infections. They received Desloratadine for symptomatic relief. In addition, half of the children were adjunctly provided with Bacillus clausii once daily for three months to study its effectiveness in reducing the symptoms. The number and overall duration of the respiratory infections were low in the group receiving the probiotic after a three-month follow-up period.
Manufacturer Product Information:
Adults:
4 to 6×(10^9) spores per day, or two to three vials of suspension per day, or two to three capsules per day.
Infants and Children:
2 to 4×(10^9) spores per day is the recommended dose in children. Use of the drug for short periods is recommended.
Acute Diarrhea in Adults:
One Bacillus clausii capsule must be administered orally twice daily for ten days.
Helicobacter Pylori Infection - Induced Adverse Effects in Adults:
A vial of Bacillus clausii is administered as an adjunct to adults during the course of treatment for H.pylori. The other drugs administered for the condition include Clarithromycin, Amoxicillin, and Rabeprazole. Bacillus clausii is advised during the first seven-day treatment period in adults, followed by seven days afterward.
Nasal Allergies in Children:
Bacillus clausii three vials a day for three weeks are administered orally to children with nasal allergies. The average age is 13.4 years.
Preterm Neonates:
In preterm neonates, less than 34 weeks gestational age, Bacillus clausii 2×(10^9) spores per 5 mL oral suspension are administered at 2 mL every eight hours mixed with enteral feeds. This delivers 2.4×(10^9) spores per day until the postnatal age of six weeks.
Small Intestine Bacterial Overgrowths in Adults:
Bacillus clausii vial is advised three times a day orally for a month.
Upper Respiratory Tract Infection in Children:
Bacillus clausii twice daily for 90 days orally in children aged three to six years.
Description:
One mini bottle contains:
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Active Ingredient: 2 billion spores of polyantibiotic-resistant Bacillus clausii.
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Excipient: Purified water.
The important characteristic of Bacillus clausii is that it can be administered during antibiotic treatment with the following antibiotics:
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Cephalosporins.
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Penicillin.
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Tetracycline.
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Macrolides.
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Aminoglycosides.
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Nova-ocin.
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Chloramphenicol.
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Thiamphenicol.
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Lincomycin.
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Isoniazid.
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Cycloserine.
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Rifampicin.
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Nalidixic Acid.
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Pipemidic Acid.
Clinical Pharmacology:
Probiotics assist in maintaining the body's natural gut microflora. The potential mechanism of action that probiotics exert includes:
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The production of pathogen-inhibitory substances.
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Inhibiting pathogen attachment.
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Inhibiting the action of microbial toxins.
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Stimulating immunoglobulin A.
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Causing trophic effects on the intestinal mucosa.
Each preparation can have a unique mechanism of action, with the bacterial strains being more or less effective comparatively. Compared to lactic acid probiotics like Lactobacilli and Bifidobacteria, the Bacillus species are highly resistant to acid and heat. The unique features of Bacillus clausii include:
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Resistance to bile and gastric acids.
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Ability to survive in high salt concentrations.
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It can adhere to the intestinal wall.
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It can promote epithelial proliferation.
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Can survive transit through the gastrointestinal tract.
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Extensively resistant to heat and acid.
These properties enable Bacillus clausii to be stored in a desiccated form and without refrigeration without affecting its viability. In addition, experimental studies have shown that Bacillus clausii affects the homeostasis of the intestinal mucosa through the regulation of gene expression. The up and down-regulation of genes involved in inflammation, infection, cell growth, apoptosis, cell adhesion, transcription, defense response factors, and cell communication was observed in the small intestinal mucosa.
Use in Specific Populations:
Use in Pregnancy and Lactation:
Bacillus clausii can be safely used during pregnancy, lactation, and breastfeeding infants.
Use in Preterm Infants:
Bacillus clausii has been used safely in preterm infants (less than 36 weeks of gestational age). This data is from a clinical study that included 244 neonates.
Overdosage:
There were no reported side effects with Bacillus clausii overdosage. Also, a missed dose did not cause any untoward effects. However, it is recommended to take the prescribed dose for more effectiveness of the medicine.
Toxicology:
There is no available data about the toxicology of Bacillus clausii.
