Wednesday, September 28, 2022

Probiotics And Ulcerative Colitis Vsl3

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Sample Size And Statistical Analysis

The sample size was based on a mean SCCAI value of 7 with a standard deviation of 4. A sample size of 15 patients achieves 80% power at a significance level of 0.05 to detect a reduction from baseline to week 8 of SCCAI by 4 between the null hypothesis mean change-from-baseline of 4 and the alternative hypothesis mean change-from-baseline of 0 with an estimated SD of 4 using a 2-sided 1-sample t-test. The sample size was calculated using PASS 2002. We aimed for a sample size of n = 20 for this study, assuming a 25% dropout rate. All data are expressed as the mean ± SEM. Statistical comparisons between pre- and post-treatments, remission versus treatment failure, were performed using Student’s t-test . Frequencies of scores were summarized by grade, causality, and week of therapy using frequencies and percentages. SPSS was employed in all statistical analysis.

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References

  • Gionchetti P, Rizzello F, Morselli C, Poggioli G, Tambasco R, Calabrese C, Brigidi P, Vitali B, Straforini G, Campieri M. High-dose probiotics for the treatment of active pouchitis. Dis Colon Rectum. 2007 Dec 50:2075-82 discussion 2082-4. Epub 2007 Oct 13. PMID: 17934776
  • Probiotics VSL#3 and Vivomixx have been removed from the Drug Tariff, following review by Advisory Committee on Borderline Substances .
  • Lee JH, Moon G, Kwon HJ, Jung WJ, Seo PJ, Baec TY, Lee JH, Kim HS. Effect of a probiotic preparation in patients with mild to moderate ulcerative colitis. Korean J Gastroenterol. 2012 Aug 60:94-101. PMID: 22926120
  • Andrew S. Day, Steven T. Leach, Thomas A. Judd, Kashan Baba, Rebecca J. Hill, Daniel A. Lemberg. The Probiotic VSL#3 in Children With Crohn Disease in Remission. Gastroenterology May 2012 Volume 142, Issue 5, Supplement 1, Page S-37
  • Andrew S. Day, Steven T. Leach, Daniel A. Lemberg, Thomas A. Judd, Kashan Baba, Rebecca J. Hill The Probiotic VSL#3 in Children With Active Crohn Disease. Gastroenterology May 2012 Volume 142, Issue 5, Supplement 1, Page S-378
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    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 Safety Of Probiotics

    VSL 3 High Potency Probiotic Capsules for Ulcerative ...

    Probiotics generally dont have severe side effects. You might experience an upset stomach, diarrhea, bloating, and gas when you begin taking them. However, some people have allergic reactions to probiotics, and theyre not recommended for people who might have weakened immune systems, such as people who have just had surgery or who are undergoing chemotherapy.

    Some MyCrohnsAndColitisTeam members find that adjusting their diet to eat more probiotic-containing foods is easier than taking supplements. I cant take the capsules. It gives me gas and upsets my stomach. But I do eat the yogurt. I really don’t know if it helps, but it doesn’t hurt, one member said.

    Other team members say that taking probiotic supplements at a certain time or with a certain sort of food or drink can reduce side effects. One member said, I take all of my probiotics before bedtime because otherwise I get nauseous. Another member said, I have a probiotic and lemon water next to my bed and take it at least an hour before I eat anything in the morning. It gives the gut a chance to get going before I eat. Seems to help.

    Just as with any supplement, talk to your health care provider before beginning to use probiotics. Remember that the use of probiotics is not a replacement for any prescription medication you are taking for your ulcerative colitis.

    Recommended Reading: Best Probiotic Supplement Whole Foods

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    Disease Activity In Each Group

    As shown in table 3, in the 20 patients on VSL#3, total PDAI scores were low both at entry and at the time of relapse or 12 months there was no significant difference within the group between these time points . In the 16 patients on placebo, the total PDAI increased significantly from a median of 3 at study entry to a median of 11 at the time of relapse or 12 months . Similar findings were observed regarding clinical, endoscopic, and histological PDAI scores in both groups.

    Table 3

    Comparison of pouchitis disease activity index score at study entry and at the time of relapse or at 12 months in the VSL#3 and placebo groups

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    Can Probiotics Treat Other Gi Issues

    Studies show that probiotics help with symptoms of inflammatory bowel disease. But more research to form a standard treatment goes on.

    Research into whether probiotics may help people with Crohnâs disease is less clear. The studies have been small, and we need more research into what types of probiotics might work. Because of this, doctors aren’t likely to recommend probiotics to people with Crohnâs disease.

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    Vsl#3 Efficacy In Inducing Remission

    VSL#3 The Living Shield Probiotic Review

    The aggregate rate of achieving remission among patients treated with VSL#3 was 43.8% compared with 24.8% among patients treated with placebo . The OR of being in remission at the end of 8 or 12 weeks of treatment while on VSL#3 compared with placebo was 2.4 . The risk difference between the VSL#3-treated group and the placebo group was 0.201 , and the number needed to treat to achieve remission in 1 patient was 45 .

    Side effects associated with the use of VSL#3.

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    Can Probiotics Make Uc Worse

    Probiotics may help by providing good bacteria that help restore the bacterial balance in the intestine, eliminating the problem to which the immune system is responding. With the perceived danger gone, the immune system may soften or stop its attack.

    As we stated previously, probiotics may help increase the time between flare-ups and may make the symptoms of a flare-up less severe. Also, probiotics are likely less expensive than typical UC medications, and they may be safer over long periods.

    Probiotics may also protect against other bowel problems such as Clostridium difficile colitis and travelers diarrhea.

    There are a lot of benefits, but there are a few cons when using probiotics with UC. The main one is that theyre probably not useful in causing a faster remission during a flare-up of UC.

    Another con is that certain people should use them cautiously. Probiotics contain living bacteria, so they may increase infection risk in people with compromised immune systems . This is because a weakened immune system might not be able to keep the live bacteria in check, and an infection may result.

    What Should I Look For When Choosing A Probiotic

    Different probiotics provide different types or strains of good bacteria in different amounts. The number of good bacteria is measured in colony-forming units . When choosing a probiotic, you should consider both the number of different strains and the total CFU count, which is usually measured in billions.

    Recommended Reading: 1 Md Complete Probiotics Platinum

    What To Consider Before Purchasing The Best Strains For Ulcerative Colitis

    For a few countries like the United States of America, the customers prefer to purchase many varieties of products from Amazon.Amazon supplies a variety of products with credible platform.Buying form Amazon is like buying directly from the manufacturer.

    Amazon.com works as a third-party and tied with manufacturers worldwide.Amazon describes Best Strains For Ulcerative Colitis products with a clear explanation provided by its manufacturer. These information can help shoppers make the right decision easier.

    The guide provides information about the specifications of the Best Strains For Ulcerative Colitis you want, such as its pros, features, size, function, and brand.If shoppers want a Best Strains For Ulcerative Colitis with any specific features, purchasing from Amazon is the best location or platform.A list of products will appear on your laptop or monitor or Android phone as soon as you type in the features you prefer.

    How Is Vsl#3 Governed

    Living with Ulcerative Colitis and the Importance of ...

    In the UK most probiotics are governed under the same laws as foods, not medicines, and governing bodies include the European Food Safety Authority , the Food Safety Authority and the Advisory Committee on Borderline Substances.

    These bodies issue guidelines around what probiotic companies can say in relation to their product and health claims they can make. Even if a probiotic has medical evidence to support its use for a certain condition they cannot publicise this unless they go through strict medical testing – a very expensive and lengthy process.

    This is why you will often find that probiotic companies do not mention specific health conditions on their website and marketing material. Guidelines have also been issued to say that the term probiotic may no longer be used in the promotion of supplements by the companies. The Advertising Standards Authority also has oversight regarding claims made and any complaints arising. In general the industry is self-regulated so some companies choose to bend the rules around making health claims in relation to their product.

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    Data Extraction Quality And Risk Of Bias Assessment

    The review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement . The data collected included the following: absolute numbers of patients in the study, each group and each outcome, method of patient selection, duration of therapy, evaluation points for outcomes, concomitant treatments in each group, clinical and endoscopic outcome assessment method, and whether the outcome was primary or secondary. The quality of the studies and risk of bias assessment were carried out according to the Cochrane Collaboration’s tool .

    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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    Vsl#3 Does Not Protect Against Tumorigenesis In The Aom/il10/ Model Of Colitis

    To investigate the impact of probiotic intervention on development of colitis-associated CRC, we conventionalized germ-free Il10/ mice with specific pathogen free microbiota for seven weeks to establish intestinal inflammation. Conventionalizing mice born and raised in GF conditions negates the confounding factor of familial transmission of the microbiota. Tumorigenesis was then initiated with 6 weekly i.p. injections of AOM , at which point daily oral administration of VSL#3 was begun .

    Figure 1

    Experimental timeline for AOM/Il10/ model with VSL#3 interventional administration.

    Germ-free Il10/ mice were transferred to SPF conditions where they were colonized with SPF commensal bacteria for seven weeks. Tumorigenesis was then initiated with six weekly injections of AOM and VSL#3 was orally administered to mice daily throughout the remainder of the experiment. After twenty-four weeks, mice were sacrificed and tissues were harvested for assessment of microbiota, inflammation and tumorigenesis.

    My Experience With Vsl#3

    The Best Probiotic For Ulcerative Colitis

    Ive been using VSL#3® with much personal success. Any time I take a stool test, the bacteria in the genus Lactobacillus and Bifidobacterium are often at acceptable levels which I know is thanks to VSL#3®. Its so important that these levels are acceptable because they are considered keystone bacteria for a healthy microbiome . I add VSL#3® to my morning iced coffee . Its pretty simple, I just put it in a shaker, along with collagen and some other supplements to keep my symptoms at bay. VSL#3® is a must-have, especially when Im in remission, because it keeps me regular and helps keep my symptoms toan absolute minimum.

    It is important to consult with your healthcare provider to determine the appropriate dosage and length of therapy for your condition. It may take up to 1 month for the colonization of the gut to become optimally stable. VSL#3® Capsules and VSL#3® Unflavored 450B Packets are available for purchase without a prescription on www.vsl3.com. VSL#3 is stocked or available to order at all retail chains and independent pharmacies. VSL#3® is kept refrigerated behind the pharmacy counter so ask the pharmacist.

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    • DAILY PROBIOTIC SUPPLEMENTS: Mix this advanced probiotic powder into cold food or drinks.
    • RECOMMENDED: VSL#3 is highly recommended by physicians for the management of ulcerative colitis.

    How To Take Probiotics

    When you take probiotics for UC, there are two key things to know.

  • You’ll likely need to take them for a while. Your stomach acid kills bacteria, whether good or bad. Experts suggest that you take the probiotics for at least 7 to 10 days to get enough good bacteria. Studies have treated patients with probiotics for up to 6 to 8 weeks. You need millions and millions — possibly billions — to start relieving UC symptoms.
  • To keep up the benefits, you have to keep taking them. If you stop, the balance of bacteria in your colon will change and a flare-up may occur. Talk to your doctor about a long-term probiotic plan.

  • Taking them by mouth may not be best. Although it may not seem pleasant, there may be some advantages to taking probiotics rectally. A smaller dose may be possible because the probiotics skip the stomach acid. This lets more of the good bacteria reach the intestines. But for obvious reasons, most people find it easier to just swallow a pill.
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    Quality Of Life In Each Group

    As is shown in fig 4A, in the 20 patients on VSL#3, IBDQ scores were high both at entry and at the time of relapse or 12 months this difference was not statistically significant . In the 16 patients on placebo, IBDQ scores deteriorated significantly from a median of 169 at study entry to a median of 105 at the time of relapse or 12 months . Comparing the two groups, there was no significant difference at entry but the groups differed significantly at the time of the relapse or 12 months .

    Figure 4

    Inflammatory bowel disease questionnaire scores at study entry and at the time of relapse or 12 months in 20 patients who received VSL#3 and in 16 patients who received placebo . *Wilcoxon signed rank test.

    Similar results were observed for patient satisfaction with treatment . In the VSL#3 group, patient satisfaction did not change significantly from study entry to the time of relapse or 12 months . In the placebo group, patient satisfaction deteriorated significantly from a median of 4 at study entry to a median of 2 at the time of the relapse or 12 months . Comparing the two groups, there was no significant difference at entry but the groups differed significantly at the time of relapse or 12 months .

    Figure 5

    Patient general satisfaction scores at study entry and at the time of relapse or 12 months in 20 patients who received VSL#3 and in 16 patients who received placebo . *Wilcoxon signed rank test.

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