Bifidobacterium lactis CCT 7858 Improves Gastrointestinal Symptoms by Antibiotics Treatment: a Double-Blind, Randomized, Placebo-Controlled Trial

2022 ◽  
Author(s):  
Monique Michels ◽  
Emily Córneo ◽  
Luana Cucker ◽  
Carla Sasso Simon ◽  
Gabriel Fernandes Alves de Jesus ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Double Blind ◽  
Bifidobacterium Lactis

scholarly journals Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1530 ◽  
Author(s):  
Alfonso Rodriguez-Herrera ◽  
Kelly Mulder ◽  
Hetty Bouritius ◽  
Rocio Rubio ◽  
Antonio Muñoz ◽  
...  
Keyword(s):  
Infant Formula ◽  
Reference Group ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Control Infant ◽  
Breastfed Infants ◽  
Experimental Versus

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

Effect of prebiotic (fructooligosaccharide) on uremic toxins of chronic kidney disease patients: a randomized controlled trial

2018 ◽  
Vol 34 (11) ◽  
pp. 1876-1884 ◽  
Author(s):  
Christiane Ishikawa Ramos ◽  
Rachel Gatti Armani ◽  
Maria Eugenia Fernandes Canziani ◽  
Maria Aparecida Dalboni ◽  
Carla Juliana Ribeiro Dolenga ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Uremic Toxins ◽  
Trophic Factors ◽  
Secondary Outcome ◽  
Model Assessment ◽  
Double Blind ◽  
The Difference

Abstract Background Microbial-derived uremic toxins, p-cresyl sulfate (PCS), indoxyl sulfate (IS) and indole 3-acetic acid (IAA), have been associated with the burden of chronic kidney disease (CKD). Prebiotics have emerged as an alternative to modulate the gut environment and to attenuate toxin production. This trial aims to investigate the effect of a prebiotic fructooligosaccharide (FOS) on uremic toxins of non-dialysis-dependent CKD (NDD-CKD) patients. Methods A double-blind, placebo-controlled, randomized trial was conducted for 3 months. In all, 50 nondiabetic NDD-CKD patients [estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2], aged 18–80 years, were allocated to prebiotic (FOS, 12 g/day) or placebo (maltodextrin, 12 g/day) groups. Primary outcomes were changes in serum (total and free) and urinary (total) PCS. Secondary outcomes included changes in IS, IAA, serum markers of intestinal permeability (zonulin), gut-trophic factors (epidermal growth factor and glucagon-like peptide-2), eGFR, inflammation (high sensitive c-reactive protein and interleukin-6), homeostatic model assessment-insulin resistance, lipid profile and gastrointestinal symptoms. Results From 50 participants (54% men, 57.3 ± 14.6 years and eGFR 21.4 ± 7.6 mL/min/1.73 m2), 46 completed the follow-up. No changes in dietary intake or gastrointestinal symptoms were observed. There was a trend in the difference of serum total ΔPCS (treatment effect adjusted for baseline levels: −12.4 mg/L; 95% confidence interval (−5.6 to 0.9 mg/L; P = 0.07) and serum-free Δ%PCS [intervention −8.6 (−41.5 to 13.9%) versus placebo 3.5 (−28.8 to 85.5%); P = 0.07] between the groups. The trend in the difference of serum total ΔPCS was independent of eGFR and dietary protein:fiber ratio intake. No difference was found in urinary PCS. Aside from the decreased high-density lipoprotein cholesterol in the intervention, no differences were observed in the change of IS, IAA or other secondary outcome between the groups. Conclusions Our result suggests the potential of FOS in reducing serum total and free PCS in nondiabetic NDD-CKD patients.

scholarly journals Colchicine in Patients With Acute Coronary Syndrome

Circulation ◽  
2020 ◽  
Vol 142 (20) ◽  
pp. 1890-1900 ◽  
Author(s):  
David C. Tong ◽  
Stephen Quinn ◽  
Arthur Nasis ◽  
Chin Hiew ◽  
Philip Roberts-Thomson ◽  
...  
Keyword(s):  
Placebo Group ◽  
Medical Therapy ◽  
Care Service ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Clinical Manifestations ◽  
Gastrointestinal Symptoms ◽  
Double Blind ◽  
Coronary Syndrome ◽  
Standard Medical Therapy

Background: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18–85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. Results: A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group ( P =0.09, log-rank). There was a higher rate of total death (8 versus 1; P =0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P =0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). Conclusions: The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality. Registration: URL: https://www.anzctr.org.au ; Unique identifier: ACTRN12615000861550.

Gluten Causes Gastrointestinal Symptoms in Subjects Without Celiac Disease: A Double-Blind Randomized Placebo-Controlled Trial

2011 ◽  
Vol 106 (3) ◽  
pp. 508-514 ◽  
Author(s):  
Jessica R Biesiekierski ◽  
Evan D Newnham ◽  
Peter M Irving ◽  
Jacqueline S Barrett ◽  
Melissa Haines ◽  
...  
Keyword(s):  
Celiac Disease ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Double Blind

scholarly journals Tolerance and safety of the potentially probiotic strainLactobacillus rhamnosusPRSF-L477: a randomised, double-blind placebo-controlled trial in healthy volunteers

2010 ◽  
Vol 104 (12) ◽  
pp. 1806-1816 ◽  
Author(s):  
Richèle D. Wind ◽  
Hermien Tolboom ◽  
Ingo Klare ◽  
Geert Huys ◽  
Jan Knol
Keyword(s):  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Lactobacillus Rhamnosus ◽  
Probiotic Strain ◽  
Blood Parameters ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Liver And Kidney ◽  
Haematological Analysis ◽  
Susceptibility Profiles

In Europe, the speciesLactobacillus rhamnosusis currently on the Qualified Presumption of Safety list used by the European Food Safety Authority (EFSA) for internal safety assessment, but according to the EFSA the species should remain a topic of surveillance. In the present study, the safety and tolerance of the potentially probiotic strainL. rhamnosusPRSF-L477 was investigated in a placebo-controlled double-blind volunteer trial following FAO/WHO guidelines. A total of thirty-four subjects received daily doses of 1 × 1011colony-forming units (cfu) ofL. rhamnosusPRSF-L477 (n17) or placebo (n17) for a period of 3 weeks, followed by a wash-out period of another 3 weeks. A questionnaire on gastrointestinal tolerance and a diary was kept daily to record compliance throughout these 6 weeks. Faecal and blood samples were collected for microbiological and haematological analysis. The recorded gastrointestinal symptoms, defecation frequency and stool consistency were not influenced indicating thatL. rhamnosusPRSF-L477 was well tolerated. The speciesL. rhamnosuswas detected in the faeces of sixteen out of seventeen subjects of the probiotic group during the intervention period. Using pulsed-field gel electrophoresis, re-isolates ofL. rhamnosusPRSF-L477 were confirmed in nine of these subjects. Antibiotic susceptibility profiles of these re-isolates were unchanged compared with PRSF-L477. No clinically relevant changes in blood parameters such as liver and kidney function and no serious adverse events appeared during and after administration. Therefore, we conclude thatL. rhamnosusPRSF-L477 can safely be administrated to healthy subjects at a daily dose of 1 × 1011 cfu.

scholarly journals USING BREWER’S YEAST AND GINGER IN THE MANAGEMENT OF CONSTIPATION-PREDOMINANT IRRITABLE BOWEL SYNDROME: A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

2019 ◽  
pp. 372-376 ◽  
Author(s):  
ZAINAB G AL-JASSIM
Keyword(s):  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Abdominal Distention ◽  
Controlled Study ◽  
Brewer’S Yeast ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Brewer's Yeast ◽  
Irritable Bowel

Objective: The objective of the present study is to confirm and/or prove the beneficial outcomes from using Brewer’s yeast and Ginger in constipation-predominant irritable bowel syndrome (IBS-C) subjects compared to placebo. Methods: A total of 45 patients suffering from IBS-C were enrolled in a double-blind placebo-controlled study as defined by Rome III criteria. Parallel groups were randomly assigned in this study: A placebo group, Brewer’s yeast group, and ginger group, taken daily for 20 days. IBS severity scale and visual analog scale for IBS (VAS-IBS) were used to assess the severity of pain, abdominal distention, and constipation (IBS-C) subjects. The data were measured at 3 times: At 0 time (T0), after 10 days of treatment (T10), and after 20 days of treatment (T20) for the three treatment groups. Results: Intragroup analysis showed a clinically significant reduction in the symptoms of abdominal pain, distention, and constipation, in the Brewer’s yeast group compared to placebo after the 20 days of the study. There was also a significant reduction of abdominal distention and constipation symptoms in the ginger group throughout the study. Conclusion: This study reveals the beneficial effects of Brewer’s yeast and ginger in reducing troublesome gastrointestinal symptoms in subjects with IBS-C and holds the promise to use them in IBS-C patient.

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