The Effect of Inactivated Lactobacillus LB Fermented Culture Medium on Symptom Severity: Observational Investigation in 297 Patients with Diarrhea-Predominant Irritable Bowel Syndrome

Abstract

Introduction: Little is known about the intensity of symptoms of diarrhea-predominant IBS (IBS-D) or the consequences of the disease on patients’ health-related quality of life (HRQOL). This observational investigation assessed the symptoms (abdominal pain, bloating, number of stools per day, and stool consistency), impact on HRQOL, and consequence on anal continence in 297 patients with IBS-D before and after 1 month of probiotic treatment with Lacteol (inactivated Lactobacillus LB plus fermented culture medium). Methods: Functional assessment using a standardized visual analogue scale in order to quantify abdominal pain, bloating, and quality of life before and after 1 month of treatment with 2 capsules/day of Lacteol. The number of symptomatic days per week, number of stools, consistency of stools, secondary fecal incontinence rate, and potential trigger effect of food were quantified. A χ² test was used to compare qualitative data and the variance of quantitative criteria was analyzed. Results: The pain score decreased from 4.46 ± 0.15 on a scale of 0–10 before treatment to 2.8 ± 0.14 after treatment (p < 0.0001). Bloating decreased from 4.49 ± 0.18 to 2.5 ± 0.15 on a scale of 0–10 (p < 0.0001). The HRQOL score, which is inversely correlated with quality of life, decreased from 5.99 ± 0.14 to 3.92 ± 0.16 (p < 0.0001). In this cohort study, the fecal incontinence rate secondary to diarrhea was clearly higher than that of the general population: 18% versus a prevalence of 9–10%, according to different studies. The mean number of stools per week decreased from 17.59 to 12.83 after treatment (p < 0.0001). Before treatment, 54% of patients had watery stools and 46% had smooth stools; at the end of treatment, only 18.5% of patients still had watery stools, and 34% had normal stools. 52% of patients attributed their symptoms to their diet: 34% to vegetables, 29% to fruit, 15% to milk, 15% to fat, 6% to peppers and spices, and 4% to sugar. Conclusion: This observational investigation shed new light on patients with IBS-D, the HRQOL of which is altered by a fecal incontinence rate twice as high as that of the general population. Correlation with diet is confirmed by 1 out of 2 patients reporting poor tolerance of fiber and dairy products. Nutritional management should thus be part of these patients’ treatment. Inactivated Lactobacillus LB plus fermented culture medium is a probiotic drug that has been used by physicians for a long time to treat patients with diarrhea. Strongly concentrated, it has no side effects and seems to help these patients. Due to a strong placebo effect in patients with this pathology, however, a controlled study is necessary to confirm this result.