The probiotic Bacillus subtilis BS50 decreases gastrointestinal symptoms in healthy adults: a randomized, double-blind, placebo-controlled trial

Abstract: Durable spore-forming probiotics are increasingly formulated into foods, beverages, and dietary supplements. To help meet this demand, the safety and efficacy of daily supplementation of Bacillus subtilis BS50 for 6 weeks was investigated in a randomized, double-blind, placebo-controlled, parallel clinical trial of 76 healthy adults. Before and during supplementation, gastrointestinal symptoms were recorded daily using a multi-symptom questionnaire. Clinical chemistry, hematology, plasma lipids, and intestinal permeability and inflammation markers were measured at baseline and end of study. Compared to placebo, 2 × 109 colony-forming units (CFU) BS50 per day increased the proportion of participants showing improvement from baseline to week 6 in the composite score for bloating, burping, and flatulence (47.4% vs. 22.2%), whereby the odds of detecting an improvement were higher with BS50 (OR [95% CI]: 3.2 [1.1, 8.7], p = .024). Analyses of individual gastrointestinal symptoms indicate that BS50 increased the proportion of participants showing an improvement at week 6 compared to placebo for burping (44.7% vs. 22.2%, p = .041) and bloating (31.6% vs. 13.9%, p = .071), without affecting other symptoms. There were no clinically meaningful changes in clinical chemistry, hematology, plasma lipids and intestinal permeability and other inflammation markers. In conclusion, the results suggest that dietary supplementation of 2 × 109 CFU Bacillus subtilis BS50 per day is a well-tolerated and safe strategy to alleviate gas-related gastrointestinal symptoms in healthy adults. ABBREVIATIONS: AE adverse event; BHD bowel habits diary; BMI body mass index; BSS Bristol Stool Scale; CFU colony-forming unit; CRP C-reactive protein; FGID functional gastrointestinal disorder; GI gastrointestinal; GITQ Gastrointestinal Tolerance Questionnaire; GLP-1 glucagon-like peptide 1; GSRS Gastrointestinal Symptom Rating Scale; HDL-C high-density lipoprotein-cholesterol; IBS irritable bowel syndrome; IL-10 interleukin-10; ITT intent-to-treat; LBP lipopolysaccharide binding protein; LDL-C low-density lipoprotein-cholesterol; PP per protocol; PYY peptide YY; TG triglyceride; total-C total cholesterol.

Self-Care Support for Patients with Gastrointestinal Cancer: iCancerHealth.

BACKGROUND: Patient-centered symptom assessment and management tools allow patients to perform self-assessments and engage in self-symptom management. Efficacious tools exist for reducing symptom distress; however, little is known about feature-specific use. OBJECTIVES: This article evaluates the feasibility of the iCancerHealth app as an adjunct to usual patient education regarding cancer symptoms and medication management. METHODS: We conducted a single-arm, pilot study grounded in the health outcomes model. Our evaluation included (1) enrollment rates, (2) 2-month utilization rates, (3) patient acceptability, and (4) clinician satisfaction with the provider-side application. English-speaking, adult patients receiving care in the gastrointestinal oncology service of a comprehensive cancer center were invited to participate. Research coordinators enrolled consenting participants who had a personal, Internet-connected device; participants registered and used the platform to complete the baseline symptom assessment in clinic. Participants were reminded weekly to use the app and to perform a symptom report 4 to 6 weeks later. RESULTS: A total of 64 patients were approached, of which 57 (89%; 95% exact confidence interval [CI], 79-96%) enrolled. About half were ≥ 60 years old and 40% were women. Fifty-three patients (93%; 95% exact CI, 85-99%) accessed at least one app feature, at least once, from home. The most frequently used (86%) feature was Health Tracker in which participants monitored and reported symptoms; followed by My Inbox (63%) and My Medications features (60%). The mean acceptability score was 24.8 (standard deviation = 4.2), indicating good acceptability. Clinicians reported that the app was most acceptable with regard to facilitating in-person interactions that occurred after app use. CONCLUSION: In a sample of adults with various stages of gastrointestinal malignancies, the iCancerHealth app was utilized at a high rate. Features that focused on symptoms and medication side effects plus communication with clinicians were used most frequently. This extends our understanding of preferences and specific feature use with patient-centered technologies.

Patient cues and symptoms of psychosocial distress: what predicts assessment and treatment of distress by oncology clinicians?

OBJECTIVE: Psychosocial concerns arise after a cancer diagnosis and during treatment requiring oncology clinicians to initiate discussions to identify distress. This study examined patient-clinician communication about psychosocial concerns and predictors of assessment and treatment/referral for distress. METHODS: Secondary analysis of existing dataset coded to explore patient-clinician communication during ambulatory visits in two comprehensive cancer centers was carried out. Sample included adult patients with various cancers and stages. Dataset included audio-recordings and symptom/QOL reports 4-6 weeks after starting treatment from all distressed patients (n = 66) in parent study and random sample of nondistressed patients (n = 23). Distressed patients had moderate-to-severe depression (Patient Health Questionnaire-9 scores ≥10) and/or poor emotional functioning (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire emotional function scores <50). Audio-recordings were coded to describe patient-clinician communication about psychosocial concerns using the coding scheme from the parent study plus Medical Interview Aural Rating System. RESULTS: The remaining patients gave 222 cues of psychosocial concerns: 183 from 46 distressed patients and 39 from nine nondistressed patients. Distressed patients were younger, were female, had higher symptom burden, and/or gave more cues. Significantly, more distressed patients had at least one cue/visit. Clinicians initiated 62% of discussions overall with no statistical difference between distressed and nondistressed groups. More explicit cues and more than four cues predicted treatment/referral for distress. CONCLUSIONS: Distressed patients were younger, were female, had higher symptom burden, and/or gave more verbal cues. Clinicians responded to explicit and more frequent cues by providing treatment and/or referrals for distress. Further exploration is needed regarding clinician factors related to assessment of psychosocial concerns.