Formulated Dosage Forms

BACIILAC

Composition
Each Hard Gelatin Capsule Contains
Streptococcus faecalis 30million CFU
Clostridium butyricum 2million CFU
Bacillus mesentericus 1million CFU
Lactic acid bacillus 50million CFU
(lactobacillus sporogenes)

What are probiotics?
Probiotics are bacteria that help keep the natural balance of organisms (microflora) in the intestines. The normal human digestive tract contains about 400 types of probiotic bacteria that reduce the growth of harmful bacteria and promote a healthy digestive system. The largest group of probiotic bacteria in the intestine is lactic acid bacteria, of which Lactobacillus acidophilus, found in yogurt with live cultures, is the best known. Yeast is also a probiotic substance. Probiotics are also available as dietary supplements.

It has been suggested that probiotics be used to treat problems in the stomach and intestines. But only certain types of bacteria or yeast (called strains) have been shown to work in the digestive tract. It still needs to be proved which probiotics (alone or in combination) work to treat diseases. At this point, even the strains of probiotics that have been proved to work for a specific disease are not widely available.

What are probiotics used for?
Many people use probiotics to prevent diarrhea, and cramping caused by antibiotics. Antibiotics kill “good” (beneficial) bacteria along with the bacteria that cause illness. A decrease in beneficial bacteria may lead to digestive problems. Taking probiotics may help replace the lost beneficial bacteria. This can help prevent diarrhea.

A decrease in beneficial bacteria may also lead to other infections, such as vaginal yeast and urinary tract infections, and symptoms such as diarrhea from intestinal illnesses.

Probiotics may also be used to:

• Help with other causes of diarrhea.
• Help prevent infections in the digestive tract
• Help control immune response (inflammation), as in inflammatory bowel disease (IBD).
Probiotics are being studied for benefits in colon cancer, skin infections, and irritable bowel syndrome (IBS). Are probiotics safe?
Most probiotics are like what is already in a person’s digestive system. Some probiotics have been used for a very long time throughout history, such as in fermented foods and cultured milk products. These don’t appear to cause illness. But more study is needed on the safety of probiotics in young children, the elderly, and people who have weak immune systems.
As with any dietary supplement, be aware that probiotic supplements are regulated as foods, not drugs. Tell your doctor about everything you are taking, including the specific bacteria in your probiotic supplement.

Prebiotics
Prebiotics are dietary substances (mostly consisting of nonstarch polysaccharides and oligosaccharides poorly digested by human enzymes) that nurture a selected group of microorganisms living in the gut. They favor the growth of beneficial bacteria over that of harmful ones. Commonly known prebiotics are Oligofructose Fermentation of oligofructose in the colon results in a large number of physiologic effects, including:

Increasing the numbers of bifidobacteria in the colon
Increasing calcium absorption
Increasing fecal weight
Shortening gastrointestinal transit time
Possibly, lowering blood lipid levels
The increase in colonic bifidobacteria has been assumed to benefit human health by producing compounds to inhibit potential pathogens, by reducing blood ammonia levels, and by producing vitamins and digestive enzymes. Synbiotics are appropriate combinations of prebiotics and probiotics. A synbiotic product exerts both a prebiotic and probiotic effect Probiotics mechanism

Immunologic benefits
Activate local macrophages to increase antigen presentation to B lymphocytes and increase secretory immunoglobulin A (IgA) production both locally and systemically

Modulate cytokine profiles
Induce hyporesponsiveness to food antigens
Nonimmunologic benefits
Digest food and compete for nutrients with pathogens
Alter local pH to create an unfavorable local environment for pathogens
Produce bacteriocins to inhibit pathogens
Stimulate epithelial mucin production
Scavenge superoxide radicals
Enhance intestinal barrier function
Compete for adhesion with pathogens
Modify pathogen-derived toxins
Prebiotics Mechanism
Metabolic effects: production of short-chain fatty acids, fat metabolism, absorption of ions (Ca, Fe, Mg) Enhancing host immunity (IgA production, cytokine modulation, etc.) Clinical applications
Current insights into the clinical applications for various probiotics or prebiotics are summarized below (in alphabetical order). Cardiovascular disease

The use of probiotics/prebiotics for preventative medicine and decreasing risk of cardiovascular disease is still unproven.

Colon cancer
The SYNCAN study tested the effect of oligofructose plus two probiotic strains in patients at risk of developing colonic cancer. The results of the study suggest that a synbiotic preparation can decrease the expression of biomarkers for colorectal cancer.

Diarrhea
Treatment of acute diarrhea: Reducing the severity and duration of acute infectious diarrhea in children. The oral administration of probiotics shortens the duration of acute diarrheal illness in children by approximately 1 day.

Antibiotic-associated diarrhea:

Radiation-induced diarrhea:
Eradication of Helicobacter pylori

Several lactobacilli and bifidobacterial strains, appear to reduce the side effects of antibiotic therapies and improve patient compliance. Several strains were effective in decreasing side effects, but did not have effects on the eradication rate. A recent meta-analysis of 14 randomized trials suggests that supplementation of anti–H. pylori antibiotic regimens with certain probiotics may also be effective in increasing eradication rates and may be considered helpful for patients with eradication failure. There is currently insufficient evidence to support the concept that a probiotic alone, without concomitant antibiotic therapy, would be effective.

Allergy
The strongest evidence is for the prevention of atopic dermatitis when certain probiotics are administered to pregnant mothers and newborns up to 6 months of age. However, a recent clinical trial did not confirm these results. With regard to the treatment of allergic disease, a few well-designed studies have provided evidence that specific probiotic strains can be effective in the treatment of a subset of patients with atopic eczema. Little is known about the efficacy of probiotics in preventing food allergy.

Hepatic encephalopathy
Prebiotics such as lactulose are commonly used for the prevention and treatment of this complication of cirrhosis. Minimal hepatic encephalopathy was reversed in 50% of patients treated with a synbiotic preparation (four probiotic strains and four fermentable fibers, including inulin and resistant starch) for 30 days.

Immune response
There is suggestive evidence that several probiotic strains and the prebiotic oligofructose are useful in boosting the immune response. Indirect evidence has been obtained in studies aimed at preventing acute infectious disease (nosocomial diarrhea in children, influenza episodes in winter) and studies that tested antibody responses to vaccines.

Inflammatory bowel disease (IBD) Pouchitis:
There is good evidence for the usefulness of probiotics in preventing an initial attack of pouchitis and in preventing further relapse of pouchitis after the induction of remission with antibiotics. Probiotics can be recommended to patients with pouchitis of mild activity, or as maintenance therapy for those in remission.

Ulcerative colitis:
The probiotic E. coli Nissle strain may be equivalent to mesalazine in maintaining remission of ulcerative colitis. There is inadequate research evidence to be certain that other probiotic preparations are effective in ulcerative colitis.

Crohn’s disease:
Studies of probiotics in Crohn’s disease have been disappointing, and a recent Cochrane systematic review concluded that there is no evidence to suggest that probiotics are beneficial for maintenance of remission in Crohn’s disease.

Irritable bowel syndrome (IBS)
Several studies have demonstrated significant therapeutic gains with probiotics in comparison with placebo. A reduction in abdominal bloating and flatulence as a result of probiotic treatments is a consistent finding in published studies; some strains may ameliorate pain and provide global relief in addition.

Lactose malabsorption
Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus improve lactose digestion and reduce symptoms related to lactose intolerance.

Necrotizing enterocolitis
Clinical trials have shown that probiotic supplementation reduces the risk of necrotizing enterocolitis in preterm neonates of less than 33 weeks’ gestation. A systematic review of randomized controlled trials also indicated a reduced risk of death in probiotic treated groups. In summary, there is strong support for the use of certain probiotic strains in preterm infants.

Nonalcoholic fatty liver disease
The usefulness of probiotics as a treatment option has not been sufficiently confirmed through randomized clinical trials.

Prevention of systemic infections
There is insufficient evidence to support the use of probiotics and synbiotics in critically ill adult patients in intensive-care units.

Contra indications
No significant contra indications

STORAGE INSTRUCTIONS
Store below 25 0 C away from direct sunlight.
Keep at cool, dry ,dark place.
Product presentation
10 capsules in aluminium strip packing.

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