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Anna Ipsen Journal Summary #3 NTR 530-30-DI Practicum Professor Keri McComb Spring 2014

ARTICLE: A randomized controlled trial of probiotic 'functional food' in the management of irritable bowel syndrome
Introduction Irritable bowel syndrome (IBS) is a functional bowel disorder that effects the large intestine, causing uncomfortable symptoms such as abdominal pain, flatulence, cramping, constipation, or diarrhea. IBS currently effects 10-30% of the general population. The symptoms of IBS cause poor quality of life and therefore methods various methods of treatment and management are frequently sought out. One of the most common therapies to treat and manage the symptoms of IBS is through diet alterations. In several small, uncontrolled studies, a positive correlation between ingestion of function foods containing probiotics, such as yogurt, and IBS symptom relief has been shown. Many of these studies have used a functional food with a fermented milk product containing the probiotic bifidobacterium lactis CNCM I-2494 combined with lactic acid bacteria. These studies showed beneficial effects on overall gut functioning, shortening colonic transit time, improving abdominal distention, and reducing discomfort in patients with IBS. This trial was designed to compare improvements using a Subjective Global Assessment of symptom relief, individual symptoms, and quality of life over a 12 week period in individuals with IBS and constipation, consuming either a commercially available product containing active probiotics or an inactive identical product containing no probiotics. Study Design/Methods The study was a randomized placebo controlled trial involving 13 general practices in the United Kingdom that were part of the Midlands Research Practices Consortium. Patients were found through the electronic records of these general practices, search on the basis diagnosis of IBS for greater than six months or having had received two or more prescriptions within the previous 24 months for antispasmodics, bulking agents, or laxatives. Patients that met the initial search qualifications, were then sent a confirming screening questionnaire and were followed-up with a telephone interview to verify their responses. Inclusion criteria included being 18-65 years old, meeting ROME 3 criteria for diagnosis of IBS with symptoms being present greater than six months and reported constipation. If this criteria was met as well, the patient was mailed and asked to keep a symptom diary two weeks prior to randomization for the study. The dairies were then screened and further exclusions were made if the patient had an IBS Symptom Severity Score of less than 75, reported passing more than three soft stools per day in absence of laxative medication, had a known organic disease, were pregnant or breastfeeding, were lactose intolerant, had a BMI greater than 35 or less than 18, or had changed medication regimen within the last month. The test product was a commercially available product containing 1.25X1010 colony forming unist of bifidobacterium lactis per cup and 1.2X109 of S. thermophilus and L. bulgaricus. The control product was a milk-based, non-fermented dairy product without

probiotics and had similar lactose content to the test product. Both products were unflavored, contained 125 grams, and prepared specifically for the purpose of the trial. Patients were instructed to consume the product twice a day. All patients received a two week supply in first instance and instructions on how to collect repeat supplies the total 12 weeks. An allocation list was sent to sponsors for product production prior to randomization, to ensure that a two week supply of allocated products would be available upon randomization. Nurses, general practitioners, patients, and research team were all blinded to allocation until analyses had been completed. Patients involved in the study returned their completed daily symptom diaries at baseline and at each follow up appointment at four, eight, and 12 weeks. Diaries were assessed for various items including the primary outcome of the Subjective Global Assessment for symptom relief. Stool frequency and consistency were assessed using the Bristol Stool Scale. Bowel movement difficulty was determined using a likert scale. The Birmingham IBS Symptom Score, was used to assess pain, diarrhea, constipation, with higher scores indicating a greater well being. The IBS-SSS, a questionnaire of five questions was used to show a greater symptom burden with a higher score. A IBS specific quality of life tool that focuses on dysphoria, interference of symptoms with activity, body image, health worry, food avoidance, social reaction, sexual and relationship was also used, with higher scores implying a greater quality of life. The primary outcome was pre-specified as the Subjective Global Assessment of symptom relief at four weeks in line with previous trial evidence on which study was powered and after discussion with the product manager and sponsor. The comparison of all other outcomes at weeks four, eight, and 12 between placebo and control groups formed the secondary outcomes. Statistical Analysis The sample size for this study was based on a previous study demonstrating a 20% group difference between active and control groups using the Subjective Global Assessment for symptom relief. Therefore, 107 patients with IBS were required in each group to demonstrate a 20% difference between groups in proportions reporting adequate IBS symptom relief at week four, with a significance of five percent and 80% power. To account for drop-out, a total of 240 (to be divided into two groups of 120) patients was the target recruitment number for this study. Data analyses for all outcomes were performed on an intention to treat basis and further analyses were undertaken to compare difference in those not deviating from protocol. ANCOVA with primary care center as a random effect, baseline as a covariate and product as a fixed effect was used to compare the intervention and control groups with respect to all outcomes. Ordinal logistic regression with center and product as fixed effects was then used to explore change within each arm of the study. Results After multiple screens and exclusions of potential candidates from the 13 general practices, a total of 179 patients met and took part in the study. Eighty-eight individuals consumed the active product and a total of 91 consumed the control product. The two groups were similar at baseline in IBS symptom severity scores, demographics, medical history, and concomitant disease, with only the exception of mental illness, in which nine in the active group and one in control group were diagnosed. Of the 179 patients, 109 had available data for the Subjective Global Assessment at week four (60 active, 49 control). No differences were found between groups with 56.7% of the active

group and 53.1% of the control group reporting adequate symptom relief. Drop-out rate at week four reached 39%, 48% at week eight, and 55% at week 12, due to range of factors such as dislike of product taste, changes in personal circumstances, and adverse events such as nausea. At week eight, a greater benefit in symptom relief in the control group (68.3% versus 46.2%) was determined and was similarly sustained at week 12 (75.8% versus 45.8%). During the initial four weeks of the study, a statistically significant improvement from baseline was reported in both groups for the majority of outcomes including bloating, flatulence, ease of bowel movement, and quality of life. However, this was not a significant between groups and these results remained consistent at week eight. At week 12, scores differed significantly between groups. Those who were receiving the control product showed greater improvement than those receiving the active product. Conclusion/Discussion In conclusion, both inactive and active product groups demonstrated improvement in symptom relief and quality of life outcomes. This improvement was maintained throughout the 12 weeks. However, at week 12, improvement was greater in the control group. This could be due to differential drop-outs between active and control group. The improvement seen in both groups suggests a potential benefit from regular dairy consumption, but cannot imply an additional benefit from the addition of a probiotic in functional foods when treating and managing IBS. The drop-out rate may be related to baseline symptom severity scores with those remaining in the study having greater baseline symptom severity scores than those withdrawing. The greater benefit was accrued by those with more severe symptoms at baseline, encouraging continued participation and may reflect greater motivation to pursue therapy in this group. The strengths of the study included it being the largest trial of probiotics in the treatment and management of IBS to date and it being the only study to test the uses functional food with probiotics. Weaknesses of the study include not reaching target recruitment of 240 patients, which reduced the power of study to 47%, and the high drop- out rate. The results of this trial suggest that clinical practitioners may wish to recommend the regular use of fermented dairy products (with or w/o probiotic) to patients with IBS for symptom relief. Further research however is still needed to investigate the effectiveness of dairy products and probiotics in the treatment and management of patients with IBS due to the mixed results and conclusions in already published literature. Works Cited Roberts LM, McCahon D, Holder R, Wilson S, Hobbs FRD. A randomized controlled trial of a probiotic 'functional food' in the management of irritable bowel syndrome. BMC Gastroenterology. 2013; 13(45). doi:10.1186/1471-230X-13-45

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