Study Medication And Compliance
The probiotic preparation used in this study was VSL#3 . VSL#3 3 g sachets contain 300 billion bacteria/g, comprising four strains of lactobacilli , three strains of bifidobacteria , and one strain of Streptococcus salivarius subspthermophilus. Placebo sachets contained maize.
Compliance was assessed by counting the dispensed and returned sachets, as well as by questioning patients. Compliance rate was calculated by dividing the number of taken sachets by that of dispensed sachets.
Medication consisted of either VSL#3 6 g once daily in the evening or identical appearing placebo sachets. Patients took the sachets for 12 months, provided their pouchitis did not relapse.
Vsl#3 Efficacy In Attaining Improvement
A decrease of > 50% in the UCDAI was the primary endpoint in the largest 2 studies. The aggregate rate of achieving this outcome among patients treated with VSL#3 was 44.6% compared with 25.1% among patients treated with placebo . The OR of experiencing more than a 50% decrease in UCDAI while on VSL#3 compared with placebo was 2.793 . The risk difference between the VSL#3-treated and the placebo-treated groups was 0.203 , and the number needed to treat to achieve more than a 50% reduction in UCDAI in 1 patient was 45 .
The efficacy of adding VSL#3 compared to placebo in decreasing UCDAI > 50%.
Side Effects And Limits Related To Vsl#3
There are almost no serious side effects related to the use of VSL#3 in most diseases. Among these side effects, only very few are intolerable. A meta-analysis showed that 33 patients experienced mild side effects out of 353 UC patients treated with VSL#3. Three patients experienced abdominal pain out of 60 patients with HE who received VSL#3. One patient was reported to experience abdominal cramps, vomiting, and diarrhea out of 20 patients with pouchitis who received VSL#3. Finally, of the 31 pouchitis patients treated with VSL#3, two experienced intolerable side effects: One experienced bloody bowel movements and the other experienced severe constipation, bloating, and gas.
The use of VSL#3 also has some limits. VSL#3 contains only eight bacterial strains, and the intestinal microecosystem of each patient is complex, so these strains may not be suitable for all patients. Achieving the one-to-one treatment of formula probiotics and individuals is difficult. The results mentioned above of VSL#3 in the treatment of various diseases are not exactly consistent, which may have been caused by different sources of VSL#3. One study indicated that proteomic analyses showed differences in protein abundances, identities, and origins of VSL#3 from different sites. Therefore, we suggest that the protein abundances should be identified through proteomic analyses in the clinical and basic studies of VSL#3 in the future.
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General Health Of Mice In Each Group
As shown in Figure , compared to the control mice, the body weight loss was significantly higher in mice treated with azoxymethane/dextran sulfate sodium after day 10 of DSS administration, which was accompanied by colitis symptoms, such as loose and bloody stool and dim body hair, fatigue, and less movement. These symptoms were alleviated when the mice received ordinary drinking water. In week 9, some mice treated with AOM/DSS presented bloody stool again, as well as, anal prolapse in week 10. However, no apparent weight loss was observed in the control mice, and no significant differences were detected among the five groups at the end of week 12.
Body weight in each group.
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Illumina V6 16s Library Construction
The V6 hypervariable region of the 16S rRNA gene was amplified using a two-step PCR strategy. The first step uses primers to the V6 region of the 16S gene that contain a 46 nucleotide barcode for multiplexing. The subsequent PCR adds Illumina paired-end sequencing adapters and a flow-cell adapter on the 5 and 3 ends of the amplicon. Amplicons were visualized on 1.5% agarose gel and purified using the QIAquick PCR purification kit . 50ng of DNA from each sample was pooled to a final concentration of 29ng/ul and subjected to paired-end Illumina HiSeq2000 sequencing at the University of North Carolina High Throughput Sequencing Facility.
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Pcr Detection Of Streptoccoccus Thermophilus And Bifidobacterium
Amplification reactions were carried out in a Biometra Thermal Cycler II . Dynazyme II was used as a thermostable polymerase. The total volume of each reaction mixture was 25 ml and cells from plate colonies were used directly as templates, without isolation of chromosomal DNA. Amplification of S thermophilus was obtained using the primer set ThI/ThII developed by Timisjärvi and Alatossava in 1997. The reaction mixture consisted of 200 M of each dNTP, 1 M of ThI and ThII primer, and 1 U of Dynazyme II. The amplification profile was 95°C for one minute, 55°C for 30 seconds, and 72°C for one minute. This was repeated for 40 cycles. The programme also included preincubation at 95°C for five minutes before the first cycle and a final incubation at 72°C for five minutes. Bifidobacteria amplification using the primer sets Bif164/Bif662 , InfY-BV.L/R and BreY-BV.R/L , specific for the genus Bifidobacterium and for the VSL-3 strains B infantis Y1 and B breve Y8, respectively, was accomplished under the following experimental conditions. Enumeration of S thermophilus,B infantis Y1, and B breve Y8 was performed by direct amplification of 3050 colonies, randomly selected from the highest dilutions of ST modified and RB agar plates. Aliquots of the amplified products were subjected to gel electrophoresis in 2% agarose gels and were visualised by ethidium bromide staining.
Effects Of Vsl#3 On Chemical Barrier Function
The chemical barrier includes bile, digestive fluid, lysozymes, mucopolysaccharides, other chemical substances, and antibacterial substances secreted by the intestinal tract. Mucus secreted by goblet cells in the intestinal epithelium forms a first-line protective mucus layer which is able to prevent foreign pathogens from penetrating the barrier into deep tissue. VSL#3 was able to increase basal luminal mucin content by 60% in Wistar rats, and it was suggested that VSL#3 regulated mucin gene expression and mucus secretion by increasing MUC2, MUC3, and MUC5AC gene expression in IEC. The changes in MUC2 and MUC5AC were more prominent than MUC3 . Besides, VSL#3 was reported to induce ileal bile acid deconjugation and fecal bile acid secretion. It exerted this effect by inhibiting the intestine-liver farnesoid X receptor-fibroblast growth factor 15 axis, which resulted in increased cholesterol-7-hydroxylase and sterol-12-hydroxylase gene expression. Besides, fecal bile acid secretion was associated with increased bile salt hydrolase transcription and enzymatic activity in VSL#3-treated mice.
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Diet & Lifestyle Advise
- Eat smaller meals more often.
- Avoid smoking and alcohol consumption. Alcohol intake leads to increased production of stomach acid, thereby increases acidity and heartburn.
- Maintain a healthy weight by regular exercising.
- Avoid carbonated and caffeinated beverages.
- Practise relaxation techniques and avoid stress by doing yoga or meditation.
- Avoid foods such as high-fat food, spicy food, chocolates, citrus fruits, pineapple, tomato, onion, garlic, tea and soda.
- Avoid deep-fried and spicy foods.
- Foods containing probiotics may help in providing relief from gas and bloating.
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Patients Concern
Vsl#3 Probiotic: Ulcerative Colitis And Ibs
VSL#3 is one of the strongest probiotics available at 450 billion bacteria per packet. To put this in perspective, Align, a probiotic promoted to help Irritable Bowel Syndrome , has only 1 billion bacteria per dose. The high concentration of good bacteria in VSL#3 may allow it to positively impact more serious and chronic conditions than other probiotics can.
Why Probiotics?
Probiotics are good bacteria. Good bacteria have a number of purposes in the body. One of their big jobs is to reduce inflammation, a hyperactive immune response associated with allergies as well as with more serious illnesses like ulcerative colitis. At the same time, good bacteria prime your immune system to attack viruses. Probiotics seem to be associated with an all around reduction in bad immunity with a simultaneous increase in good immunity.
Reduced numbers of these friendly helpers may contribute to weakened immunity and allergies, as well as inflammatory GI tract illnesses like ulcerative colitis and irritable bowel syndrome.
Research with VSL#3 over the the last decade has shown that replenishing the gut with a high dose of good bacteria can often put people with inflammatory bowel disease into remission and keep them in remission. Researchers have also found a benefit for IBS with VSL#3
Ulcerative Colitis
Pouchitis With Ulcerative Colitis Surgery
IBS
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Fecal Dna Extraction And Pyrosequencing
Microbial genomic DNA was isolated using a QIAamp DNA Micro Kit according to the manufacturers instructions. The final quantity and quality of the DNA were assessed at 260 nm and 280 nm using an ultraviolet spectrophotometer and stored at -20 °C before further analysis. The V3-V4 hypervariable regions of the 16S rDNA gene were subjected to high-throughput sequencing by Allwegene using the Illumina Miseq PE300 sequencing platform .
ELISA for tumor necrosis factor-and interleukin-6 in colon mucosa
The levels of tumor necrosis factor – and interleukin -6 in the colon mucosa were measured using commercial mouse TNF- and IL-6 ELISA Kits , according to the manufacturers protocols. The absorbance was measured at 450 nm. The results were expressed as pg/mg tissue. A total of eight mice were selected randomly from each group for ELISA.
How Is Vsl#3 Different From Other Probiotic Options
VSL#3® offers a greater diversity and number of good bacteria strains, which can help improve the balance of bacteria in your digestive tract. VSL#3® contains 8 strains of good bacteria. Many over-the-counter probiotic brands contain only 1 strain. VSL#3® Capsules contain 112.5 billion CFU, while many over-the-counter probiotics contain 20 billion CFU or less.
VSL#3® is also refrigerated to keep the bacteria alive.
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What Is A Probiotic And How Can It Help Me
Your digestive tract contains trillions of bacteria. Most bacteria are considered good bacteriathe kind that keep you healthy.
But you also have bad bacteria. People with conditions such as IBS have more bad bacteria than good bacteria in their digestive tract. More bad bacteria can cause problems that lead to uncomfortable and even debilitating symptoms, as well as anxiety that comes from having to cope with those symptoms.
VSL#3® is an advanced probiotic option that provides multiple strains of bacteria needed to restore the necessary amount of good bacteria in your digestive tract to manage your condition.
Probiotics Linked To Remission Recurrence Prevention In Ulcerative Colitis
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A new systematic review and meta-analysis of available medical literature suggested probiotics may provide some benefits to patients with ulcerative colitis, but not Crohns disease.
In particular, probiotics may be as effective as 5-aminosalicylates for preventing relapse in quiescent UC, and the probiotic medical food VSL#3 appeared effective for inducing remission in active UC.
Alex Ford
Previous meta-analyses have examined the benefit of probiotics in specific subgroups of patients with IBD, but none have synthesized all current available evidence for their role in IBD, and some have important limitations which have been reported previously,Alex Ford, MD, of the Leeds Gastroenterology Institute at St. Jamess University Hospital in the U.K., and colleagues wrote.
To perform an updated examination of the efficacy of probiotics in inflammatory bowel disease, Ford and colleagues reviewed relevant medical literature published up to November 2016, and ultimately included 22 eligible randomized controlled trials comparing probiotics with either 5-ASAs or placebo in adults with IBD.
Moreover, the investigators found probiotics and 5-ASAs were equally effective for preventing relapse in quiescent UC , based on three randomized controlled trials in which 39.7% of 277 patients who received probiotics and 39.2% of 109 patients who received 5-ASAs relapsed.
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Vsl#3 Efficacy In Attaining Response
The aggregate rate of attaining a response among patients treated with VSL#3 was 54.9% compared with 29.3% among patients treated with placebo . The OR of experiencing at least a 3-point reduction in UCDAI while on VSL#3 compared with placebo was 3.03 The risk difference between the VSL#3-treated and the placebo-treated groups was 0.26 , and the number needed to treat to achieve a reduction in UCDAI of 3 points or more in 1 patient was 34 .
The efficacy of VSL#3 compared to placebo in achieving 3-point decrease in UCDAI.
The Pros And Cons Of Probiotics For Ulcerative Colitis
Researchers are still learning about this dietary supplement. In the meantime, heres what you should know about incorporating probiotics into your colitis treatment plan.
Scan the shelves and the refrigerated section of your local supermarket or pharmacy and youre likely to spot pills, powders, supplements, and foods with probiotics from yogurt and buttermilk to miso and sauerkraut. Probiotics are live friendly bacteria that commonly inhabit the large intestine as part of its microflora and aid in digestion and normal functioning. Theyre also grown in labs and added to foods or sold as dietary supplements packing in about 10 to 20 billion colony-forming units per capsule, according to a 2008 paper in the journal American Family Physician.
Its important to note that not all probiotics are alike. There are many strains, so one may not have the same effect as another. They can vary widely in their CFUs and overall quality, and researchers arent yet sure which probiotics are helpful and which are not for ulcerative colitis or for other health conditions. However, according to a promising review published in June 2017 in Alimentary Pharmacology and Therapeutics, probiotic foods or supplements containing a probiotic called VSL #3 may help people manage UC.
Probiotics may still have a place in your treatment plan as long as you know what they can do for you.
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Vsl#3 Provides More Probiotic Support Than Leading Over
Different probiotics provide different types, or strains, of “good” bacteria in different amounts compared with VSL#3®. The number of good bacteria is measured in “colony-forming units” .
- VSL#3® contains 8 different strains of good bacteria, while the other leading OTC brands contain only 1 strain
- VSL#3® is refrigerated to keep the probiotics alive
- VSL#3® Powders contain up to 900 billion CFU, significantly higher than what is found in the other leading OTC products so more can survive in the GI tract and have a beneficial effect
Align® is a registered trademark of Procter & Gamble.Culturelle® is a registered trademark of DSM.*Reclassified as B. lactis.
Effects Of Vsl#3 On Mechanical Barrier Function
The mechanical barrier is mainly comprised of intestinal epithelial cells and the protein networks between IEC, including desmosomes, adherent junctions, and tight junctions. Tight junctions maintain epithelial polarity and regulate selective paracellular ion solute transport. Among all the components in the intestinal epithelium, VSL#3 mainly affects tight junctions. VSL#3 could lead to a recovery of tight junction protein injury with significantly increased occludin and zonula occludens-1 and significantly decreased claudin-2 in the intestinal mucosa. The influence of VSL#3 on tight junction proteins is achieved by increasing the protein level and enzymatic activity of T-cell protein tyrosine phosphatase , which is the protein product of the tyrosine-protein phosphatase non-receptor type 2 gene, and PTPN2 has a protective effect against inflammatory bowel disease . Then, VSL#3 mediates its beneficial effect by reducing interferon- signaling in a TCPTP-dependent manner and correcting the reduction in transepithelial electrical resistance . VSL#3 probably increased TER by activating the mitogen-activated protein kinase p42/44 and p38 pathway in T84 cells. Besides, the increase of phosphorylated-p38 and phosphorylated-extracellular signal-regulated kinase signaling pathways by VSL#3 is also important in improving tight junction protein expression and IBF in rats.
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Effects Of Vsl#3 On Immune Barrier Function
However, one study showed an opposite mechanism of VSL#3. It demonstrated that a high dose of VSL#3 locally stimulated epithelial innate immunity by increasing the production of TNF- and activating the NF-B pathway to restore IBF. The stimulation effect required the temporary colonization of VSL#3 in the intestinal lumen. On the other hand, another study also indicated that VSL#3 exerted its beneficial effect by producing the proinflammatory cytokines IL-6 and IL-12 in bone marrow-derived macrophages isolated from Balb/c mice.
Randomisation And Sample Size
Pharmacists at each institute were in charge of the randomisation. The results of the randomisation were known only to the pharmacists until the end of this study when the data were analysed.
Sample size was based on the estimate of 80% recurrence in the placebo group and 25% in the probiotic group over a one year period. These estimates followed relapse findings in a previous study by Gionchetti and colleagues. Eighteen patients were needed in each group to provide an 80% chance of a significant difference at the 0.05 level using a two tailed test.
Randomisation was performed separately in each institution. The number of patients to be recruited was targeted at 36 without setting the minimum or maximum number at each institution. To avoid a disproportionate number of patients in the active or placebo group at either institution, randomisation was performed in blocks of four at each institution.
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