title: Gastrointestinal symptoms after pelvic radiotherapy: role for the gastroenterologist? Effects of active addition of bacterial cultures in fermented milk to patients with chronic bowel discomfort following irradiation Effects of probiotic Lactobacillus casei DN-114 001 in prevention of radiation-induced diarrhea: results from multicenter, randomized, placebo-controlled nutritional trial. Results of a double-blind, randomized study to evaluate the efficacy and safety of Antibiophilus® in patients with radiation-induced diarrhoea Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Improving the quality of reporting in randomised controlled trials. Preservation of intestinal integrity during radiotherapy using live Lactobacillus acidophilus cultures.
abstract: PURPOSE To analyze the cause of GI symptoms after  pelvic radiotherapy ( RT )  in a consecutive series of patients with symptoms beginning after RT . A striking lack of evidence is available concerning the optimal treatment for the 50 % of patients who develop permanent changes in bowel habits affecting their quality of life after pelvic RT . As a result , in the UK , most such patients are never referred to a gastroenterologist . METHODS AND MATERIAL S All diagnoses were prospect ively recorded from a consecutive series of patients with symptoms that started after RT and who were referred during a 32-month period to a gastroenterology clinic . Patients either underwent direct access flexible sigmoidoscopy or were investigated in a st and ard manner by one gastroenterologist after first being seen in the clinic . RESULTS A total of 265 patients referred from 15 institutions were investigated . They included 90 women ( median age , 61.5 years ; range , 22 - 84 years ) and 175 men ( median age , 70 years ; range , 31 - 85 years ) . RT had been completed a median of 3 years ( range , 0.1 - 34 years ) before the study in the women and 2 years ( range , 0 - 21 years ) before in the men . Of the 265 patients , 171 had primary urologic , 78 gynecologic , and 16 GI tumors . The GI symptoms included rectal bleeding in 171 , urgency in 82 , frequency in 80 , tenesmus , discomfort , or pain in 79 , fecal incontinence in 79 , change in bowel habit in 42 , weight loss in 19 , vomiting without other obstructive symptoms in 18 , steatorrhea in 7 , nocturnal defecation in 8 , obstructive symptoms in 4 , and other in 24 . After investigation , significant neoplasia was found in 12 % . One-third of all diagnoses were unrelated to the previous RT . More than one-half of the patients had at least two diagnoses . Many of the abnormalities diagnosed were readily treatable . The symptoms were generally unhelpful in predicting the diagnosis , with the exception of pain , which was associated with neoplasia ( p < 0.001 ) . CONCLUSION The results of our study have shown that radiation enteritis is not a single disease entity . More than one-half of the patients had more than one GI diagnosis contributing to their symptoms . After pelvic RT , specific GI symptoms were not a reliable measure of the underlying diagnoses , and the evaluation of new GI symptoms is worthwhile . An algorithm for this purpose is proposed Radiotherapy is a cornerstone in the treatment of malignancies in the pelvis . Consequently , there is usually exposure of the intestine and especially the lower colon and rectum , with ensuing disturbances in bowel habits at different times following radiotherapy . The main problem is diarrhoea associated with lactose intolerance , bile salt absorption and fat malabsorption . Bacterial contamination has also been described . In the present study we have evaluated the influence of the active administration of specific bacterial cultures in fermented milk , which inhibit the growth of potentially pathogenic micro-organisms , to 40 consecutive patients with chronic alteration in their bowel habits caused by previous radiotherapy of pelvic malignancies . The results suggest that intake of fermented milk products could be of value in decreasing chronic bowel discomfort following radiotherapy of pelvic malignancies . However , a more extensive study is warranted in order to very the significance of the results and to find the optimal product PURPOSE To determine whether a probiotic drink containing Lactobacillus casei DN-114 001 reduces the incidence of radiation-induced diarrhea in patients with gynecologic cancer . METHODS AND MATERIAL S Patients who were undergoing pelvic radiotherapy ( 45 - 50 Gy , conventional fractionation ) for either cervical carcinoma ( radiotherapy and weekly cisplatin ) or endometrial adenocarcinoma ( postoperative radiotherapy ) were r and omly assigned to a probiotic drink or placebo , in a double-blind fashion . The probiotic drink consisted of liquid yogurt containing L. casei DN-114 001 at 10(8 ) CFU/g . The patients recorded the daily the number of bowel movements and scored the stool consistency using the Bristol scale . Diarrhea was grade d weekly according the Common Toxicity Criteria system . The primary endpoint was to reduce the incidence of diarrhea , defined by a Common Toxicity Criteria Grade of 2 or greater or the need for loperamide . RESULTS A total of 85 patients were enrolled .  Grade 2 or greater diarrhea and /or the use of loperamide was observed in 24 of 41 patients in the placebo group and 30 of 44 in the probiotic group ( p = 0.568 ) . No differences were found in the median time to the presentation of the primary endpoint . Probiotic intervention had a significant effect on stool consistency ( p = 0.04 ) . The median time for patients to present with Bristol scale stools of Type 6 or greater was 14 days for patients receiving the probiotic drink vs. 10 days for those receiving placebo . CONCLUSION Nutritional intervention with the probiotic drink containing L. casei DN-114 001 does not reduce the incidence of radiation-induced diarrhea as defined by a Common Toxicity Criteria Grade 2 or greater . However , it had a significant effect on stool consistency as measured by the Bristol scale Background and aims Gastrointestinal toxicity is frequently observed during radiotherapy for malignancies in the abdomen and pelvis . This study was performed to determine the efficacy and tolerability of Lactobacillus rhamnosus ( Antibiophilus ® ) in comparison to placebo in a double-blind trial design . Its aim was to determine any clinical ly relevant difference between Antibiophilus ® and placebo in terms of efficacy in patients suffering from mild to moderate diarrhoea induced by radiation therapy . Methods The study was performed in two radiotherapy units in Hungary ; the results are based on the data for 206 recruited patients . Results Based on statistical analysis , Antibiophilus ® patients showed superiority with respect to the number of bowel movements ( P < 0.10 ) and faeces consistency ratings by the investigators ( P < 0.05 ) at the study end . Statistical analysis of the patients ’ self-ratings with regard to diarrhoea grade and faeces consistency showed a statistically highly significant treatment-by-time interaction ( P < 0.001 ) which was supported by the evidence of tendencies or P values below the nominal 5 % level in the second half of this study . Conclusions Overall , there was a highly favourable benefit/risk ratio in favour of Antibiophilus ® THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information concerning the design , conduct , analysis , and generalizability of the trial . This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial . Accurate and complete reporting also benefits editors and review ers in their deliberations regarding su bmi tted manuscripts . For RCTs to ultimately benefit patients , the published report should be of the highest possible st and ard Wound-care journals contain abundant reports of trials , but not all report a satisfactory methodology . Systematic review s of wound-care trials have highlighted many areas for improvement , and the National Institute for Clinical Excellence ( NICE ) guidelines recommend that primary research in the field of pressure ulcer prevention should adhere more closely to current method ological st and ards in terms of conduct and reporting . The CONSORT tool was developed to help achieve these improvements in the design and reporting of r and omised controlled trials ( RCTs ) Twenty-four female patients suffering from gynaecological malignancies and scheduled for internal and external irradiation of the pelvic area ( pelvic dose 5000 cGy ) were selected for a study on prevention of intestinal side-effects by live Lactobacillus acidophilus cultures . The patients were r and omised into two groups . Both groups received dietary counselling recommending a low-fat and low-residue diet during radiotherapy . The control group received dietary counselling only . The test group received 150 ml of a fermented milk test product supplying them with at least 2 X 10(9 ) live Lactobacillus acidophilus bacteria daily and 6.5 % lactulose as substrate for the bacteria . The results indicated that the test product appeared to prevent radiotherapy-associated diarrhoea . However , flatulence was increased probably due to lactulose ingestion in the test group
target: Probiotic supplementation showed beneficial effect in the prevention and treatment of radiation-induced diarrhea in experimental animal studies .
background: BACKGROUND AND AIMS Probiotic supplementation seems to provide beneficial effects in the prevention and treatment of  radiation-induced diarrhea .
  We performed a systematic review and meta- analysis to estimate the efficacy of probiotic supplementation for prevention and treatment of  radiation-induced diarrhea .