scholarly journals Consuming foods with added oligofructose improves stool frequency: a randomised trial in healthy young adults

2014 ◽  
Vol 3 ◽  
Author(s):  
Wendy J. Dahl ◽  
Arnelle R. Wright ◽  
Gretchen J. Specht ◽  
Mary Christman ◽  
Anne Mathews ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Healthy Adults ◽  
Stool Frequency ◽  
Online Questionnaire ◽  
Double Blind ◽  
Fibre Intake ◽  
Intensity Score ◽  
Gi Symptoms ◽  
Symptom Intensity ◽  
The Impact

AbstractThe impact of oligofructose (OF) intake on stool frequency has not been clearly substantiated, while significant gastrointestinal (GI) symptoms have been reported in some individuals. The aim of the present study was to determine the effects of OF on stool frequency and GI symptoms in healthy adults. In an 8-week, randomised, double-blind, parallel-arm study, ninety-eight participants were provided with 16 g OF in yogurt and snack bars (twenty male and thirty female) or matching control foods (seventeen male and thirty-one female), to incorporate, by replacement, into their usual diets. Participants completed a daily online questionnaire recording stool frequency and rating four symptoms: bloating, flatulence, abdominal cramping and noise, each on a Likert scale from ‘0’ for none (no symptoms) to ‘6’ for very severe, with a maximum symptom intensity score of 24 (sum of severities from all four symptoms). Online 24 h dietary recalls were completed during pre-baseline and weeks 4, 6 and 8 to determine fibre intake. When provided with OF foods, fibre intake increased to 24·3 (sem 0·5) g/d from pre-baseline (12·1 (sem 0·5) g/d; P < 0·001). Stool frequency increased with OF from 1·3 (sem 0·2) to 1·8 (sem 0·2) stools per d in males and 1·0 (sem 0·1) to 1·4 (sem 0·1) stools per d in females during intervention weeks compared with pre-baseline (P < 0·05),but did not change for control participants (males: 1·6 (sem 0·2) to 1·8 (sem 0·2); females: 1·3 (sem 0·1) to 1·4 (sem 0·1)). Flatulence was the most commonly reported symptom. Mean GI symptom intensity score was higher for the OF group (3·2 (sem 0·3)) v. control (1·7 (sem 0·1)) (P < 0·01), with few participants reporting above moderate symptoms. No change in symptom intensity occurred over time. Consuming yogurt and snack bars with 16 g OF improves regularity in young healthy adults. However, GI symptoms, resulting from an increase in oligofructose intake, may not diminish with time.

scholarly journals Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study

2021 ◽  
Vol 14 ◽  
pp. 175628642199399 ◽  
Author(s):  
Annette Wundes ◽  
Sibyl Wray ◽  
Ralf Gold ◽  
Barry A. Singer ◽  
Elzbieta Jasinska ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Medication Use ◽  
Dimethyl Fumarate ◽  
Daily Activities ◽  
Phase Iii ◽  
Symptomatic Medication ◽  
Gi Symptoms ◽  
Symptom Intensity ◽  
The Impact

Background: Diroximel fumarate (DRF) is a novel oral fumarate approved for relapsing forms of multiple sclerosis (MS). DRF demonstrated significantly improved gastrointestinal (GI) tolerability versus dimethyl fumarate (DMF) with fewer days of Individual Gastrointestinal Symptom and Impact Scale (IGISIS) scores ⩾2, GI adverse events (AEs), and treatment discontinuations due to GI AEs. Our aim was to evaluate the impact of GI tolerability events on quality of life (QoL) for patients with relapsing–remitting MS who received DRF or DMF in EVOLVE-MS-2. Methods: A post hoc analysis was conducted in patients who were enrolled in the randomized, blinded, 5-week, EVOLVE-MS-2 [ClinicalTrials.gov identifier: NCT03093324] study of DRF versus DMF. Patients completed daily IGISIS and Global GISIS (GGISIS) eDiary questionnaires to assess GI symptom intensity and interference with daily activities and work. Results: In total, 504 patients (DRF, n = 253; DMF, n = 251) received study drug and 502 (DRF, n = 253; DMF, n = 249) completed at least one post-baseline questionnaire. With DRF, GI symptoms were less likely to interfere ‘quite a bit’ or ‘extremely’ with regular daily activities [IGISIS: DRF, 9.5% (24/253) versus DMF, 28.9% (72/249)] or work productivity [GGISIS: DRF, 6.1% (10/165) versus DMF, 11.3% (18/159)]. DRF-treated patients had fewer days with ⩾1 h of missed work (DRF, 43 days, n = 20 versus DMF, 88 days, n = 26). DMF-treated patients reported highest GI symptom severity and missed work at week 2–3 shortly after completing the titration period, which coincided with the majority of GI-related treatment discontinuations [58.3% (7/12)]. GI tolerability AEs [DRF, 34.8% (88/253); DMF, 48.2% (121/251)], concomitant symptomatic medication use [DRF, 19.3% (17/88) versus DMF, 30.6% (37/121)], and GI-related discontinuations (DRF, 0.8% versus DMF, 4.8%) were lower with DRF versus DMF. Conclusions: The improved GI tolerability with DRF translated into clinically meaningful benefits to QoL, as patients experienced less impact on daily life and work and required less concomitant symptomatic medication use. Trial registration: [ClinicalTrials.gov identifier: NCT03093324]

scholarly journals Gastrointestinal Distress, State and Trait Anxiety, and Dietary Intake Among College Students During the COVID-19 Pandemic

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 218-218
Author(s):  
Alexa Evenson ◽  
Katherine Johnson ◽  
Catherine Bohn-Gettler ◽  
Trevor Keyler
Keyword(s):  
College Students ◽  
Dietary Intake ◽  
Trait Anxiety ◽  
Gastrointestinal Symptoms ◽  
Stepwise Multiple Regression ◽  
Online Questionnaire ◽  
Somatic Anxiety ◽  
Gi Symptoms ◽  
State And Trait Anxiety ◽  
The Impact

Abstract Objectives To determine the impact of State and Trait anxiety and dietary intake on college students' gastrointestinal symptoms during the COVID-19 pandemic. Methods A total of 455 students, aged 18–23, from two residential colleges in the midwestern United States participated in the study during April 2021. An online questionnaire that included the National Cancer Institute Dietary Screener, State-Trait Inventory for Cognitive and Somatic Anxiety, and an adapted version of the Gastrointestinal Symptoms Questionnaire was used. Stepwise multiple regression analyses was used to analyze the data. Results The mean score for GI symptoms was 5.57 ± 5.25. Moderate to severe symptoms of abdominal bloating (31.8%), nausea (16.2%), passing gas (29.1%), abdominal rumbling (28.1%), abdominal cramping (20.4%), diarrhea (18.8%), and constipation (14.7%) were reported by our participants. High rates of State-somatic, State-cognitive, and Trait-somatic anxiety were present in our study population. These anxiety subscales and dietary intake predicted 26% and 3.8% of the GI symptoms variance, respectively. Conclusions State-anxiety and Trait-somatic anxiety are large factors in predicting GI symptoms compared to dietary intake. College students could seek anxiety-reducing techniques to ease GI symptoms. Funding Sources None

Activity of cediranib in alveolar soft part sarcoma (ASPS) confirmed by CASPS (cediranib in ASPS), an international, randomised phase II trial (C2130/A12118).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11004-11004 ◽  
Author(s):  
Ian Robert Judson ◽  
James P Morden ◽  
Michael Gordon Leahy ◽  
Vivek Bhadri ◽  
Quentin Campbell-Hewson ◽  
...  
Keyword(s):  
Phase Ii ◽  
Tyrosine Kinases ◽  
Soft Part ◽  
Randomised Trial ◽  
Soft Tissue Sarcomas ◽  
Significant Activity ◽  
Phase Ii Trials ◽  
Double Blind ◽  
Best Response ◽  
The Impact

11004 Background: ASPS is a rare disease (0.5-1% of soft tissue sarcomas) mainly affecting young people. It is unresponsive to conventional chemotherapy. Cediranib (C), an inhibitor of vascular endothelial growth factor receptors and other receptor tyrosine kinases, has shown significant activity in ASPS in single arm phase II trials. CASPS (NCT01337401) was designed to permit discrimination between the impact of cediranib and the often intrinsically indolent nature of the disease. Methods: CASPS compared C (30mg od) with placebo (P) in a 2:1 double blind randomisation in patients (pts) age ≥16 years with metastatic ASPS progressive in the previous 6 months. Pts were unblinded at week 24, or at progression if sooner, when those on P started C. The primary endpoint of percentage change in the sum of target marker lesions (TMLsum) between baseline and week 24 (or progression if sooner) was compared between groups by Mann-Whitney test. Secondary endpoints were progression-free survival (PFS), week 24 response rate and best response (RECIST v1.1), safety/tolerability and overall survival (OS). One-sided p-values and two-sided 90% confidence intervals are reported. Results: 48 pts were recruited between 07/2011 and 07/2016 from 12 centres (UK, Australia & Spain). 52% of pts were female, median age was 31. Most common grade ≥3 adverse events on C were hypertension (23%), diarrhoea (14%) and fatigue (9%). In the evaluable population (N = 44) median change in TMLsum on C was minus 8.3% (IQR minus 26.2% to +5.9%); versus P: +13.4% (IQR minus 0.6% to +21.3%), p = 0.0013. Best response by week 24 was partial response for 6/28 (21%) C pts compared with 0/16 on P (p = 0.053) and stable disease for an additional 19/28 (68%) on C and 12/16 (75%) on P. The PFS HR (C versus P) was 0.54 (90% CI 0.30-0.97, p = 0.041), median PFS: 10.8 mths on C versus 3.7 mths on P, OS at 12 mths was C: 96%; P: 64.3%. Conclusions: CASPS, the largest randomised trial to date in this disease, confirms the activity of C in ASPS, showing a significant reduction in tumour burden and improvement in PFS. Tumour tissue and serial blood samples will subsequently be investigated to identify potential predictive and prognostic biomarkers. Clinical trial information: NCT01337401.

scholarly journals Iron status and inherited haemoglobin disorders modify the effects of micronutrient powders on linear growth and morbidity among young Lao children in a double-blind randomised trial

2019 ◽  
Vol 122 (8) ◽  
pp. 895-909 ◽  
Author(s):  
Sonja Y. Hess ◽  
K. Ryan Wessells ◽  
Guy-Marino Hinnouho ◽  
Maxwell A. Barffour ◽  
Kanokwan Sanchaisuriya ◽  
...  
Keyword(s):  
Iron Status ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Double Blind ◽  
Adverse Health Outcomes ◽  
Modifying Factors ◽  
Micronutrient Powder ◽  
Haemoglobin Disorders ◽  
Clinically Significant ◽  
The Impact

AbstractSome studies found that providing micronutrient powder (MNP) causes adverse health outcomes, but modifying factors are unknown. We aimed to investigate whether Fe status and inherited Hb disorders (IHbD) modify the impact of MNP on growth and diarrhoea among young Lao children. In a double-blind controlled trial, 1704 children of age 6–23 months were randomised to daily MNP (with 6 mg Fe plus fourteen micronutrients) or placebo for about 36 weeks. IHbD, and baseline and final Hb, Fe status and anthropometrics were assessed. Caregivers provided weekly morbidity reports. At enrolment, 55·6 % were anaemic; only 39·3 % had no sign of clinically significant IHbD. MNP had no overall impact on growth and longitudinal diarrhoea prevalence. Baseline Hb modified the effect of MNP on length-for-age (LAZ) (P for interaction = 0·082). Among children who were initially non-anaemic, the final mean LAZ in the MNP group was slightly lower (–1·93 (95 % CI –1·88, –1·97)) v. placebo (–1·88 (95 % CI –1·83, –1·92)), and the opposite occurred among initially anaemic children (final mean LAZ –1·90 (95 % CI –1·86, –1·94) in MNP v. –1·92 (95 % CI –1·88, –1·96) in placebo). IHbD modified the effect on diarrhoea prevalence (P = 0·095). Among children with IHbD, the MNP group had higher diarrhoea prevalence (1·37 (95 % CI 1·17, 1·59) v. 1·21 (95 % CI 1·04, 1·41)), while it was lower among children without IHbD who received MNP (1·15 (95 % CI 0·95, 1·39) v. 1·37 (95 % CI 1·13, 1·64)). In conclusion, there was a small adverse effect of MNP on growth among non-anaemic children and on diarrhoea prevalence among children with IHbD.

scholarly journals Kiwifruit-derived supplements increase stool frequency in healthy adults: a randomized, double-blind, placebo-controlled study

2015 ◽  
Vol 35 (5) ◽  
pp. 401-408 ◽  
Author(s):  
Juliet Ansell ◽  
Christine A. Butts ◽  
Gunaranjan Paturi ◽  
Sarah L. Eady ◽  
Alison J. Wallace ◽  
...  
Keyword(s):  
Healthy Adults ◽  
Stool Frequency ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Gastrointestinal effects of resistant starch, soluble maize fibre and pullulan in healthy adults

2013 ◽  
Vol 110 (6) ◽  
pp. 1068-1074 ◽  
Author(s):  
Abby S. Klosterbuer ◽  
Meredith A. J. Hullar ◽  
Fei Li ◽  
Elizabeth Traylor ◽  
Johanna W. Lampe ◽  
...  
Keyword(s):  
Resistant Starch ◽  
Human Subjects ◽  
Healthy Adults ◽  
Significant Shift ◽  
Gut Health ◽  
Healthy Human ◽  
Double Blind ◽  
Gi Symptoms ◽  
And Control ◽  
Gut Microbial Community

Fibre has been shown to exert a number of benefits on gastrointestinal (GI) health, yet its intake is low. Addition of novel fibres to food products may increase fibre intake and improve gut health. The objective of the present study was to evaluate the influence of three novel fibres on GI outcomes in healthy human subjects. A total of twenty healthy participants (ten men and ten women) with normal BMI (23 (sem 2) kg/m2) participated in the present randomised, double-blind, cross-over study with five treatment periods. Participants consumed a maltodextrin control or 20–25 g/d fibre from soluble maize fibre (SCF) or resistant starch (RS), alone or in combination with pullulan (SCF+P and RS+P). The treatment periods were 7 d with a 3-week washout between the periods. Stool samples were collected on day 7 of each period, and GI tolerance was assessed via a questionnaire on days 1 and 6. There were no treatment differences in stool weight or consistency. SCF significantly reduced stool pH and increased total SCFA production compared with RS and control. RS+P significantly increased the percentage of butyrate compared with all the other treatments. Overall, GI symptoms were minimal. SCF+P led to the highest GI score on day 1, while RS+P had the highest score on day 6. Both SCF treatments caused a significant shift in the gut microbial community. These functional fibres are generally well tolerated, have minimal effects on laxation and may lead to beneficial changes in SCFA production in healthy adults.

PP27 An exploration of the experiences of paramedics taking part in a large randomised trial of airway management, and the impact on their views and practice

2019 ◽  
Vol 36 (10) ◽  
pp. e12.1-e12
Author(s):  
K Kirby ◽  
J Brandling ◽  
M Robinson ◽  
S Voss ◽  
J Benger
Keyword(s):  
Airway Management ◽  
Online Survey ◽  
Randomised Trial ◽  
Barriers And Facilitators ◽  
Trial Participation ◽  
List Type ◽  
Online Questionnaire ◽  
Advanced Airway ◽  
The Impact

BackgroundThe participation of over 1500 study paramedics in AIRWAYS-2 provides a unique opportunity for an in depth exploration of how the views and practice of study paramedics, in advanced airway management, may have developed as a result of their participation in AIRWAYS-2, and how their experiences can inform future trials in out-of-hospital cardiac arrest (OHCA). Future prehospital guidelines and practice will not only be shaped by the results of large trials such as AIRWAYS-2, but also by the views and attitudes of UK paramedics towards OHCA, airway management and research. This study allows an opportunity to add depth and understanding to the results of AIRWAYS-2.Study aimsTo explore paramedics’ experiences of participating in a large cluster randomized trial of airway management during OHCA, specifically:The challenges of enrolling patients who are critically unwell and unable to consent;Barriers and facilitators to successful research in OHCA patients;The impact on paramedics’ clinical practice and airway management during and after the trial;The role of advanced airway management during OHCA.MethodsContent analysis of an online survey of 1500 study paramedics to assess their experiences of participating in the trial and to establish any changes in their views and practice.Thematic analysis of telephone interviews with study paramedic to explore the findings of the online questionnaire. Exploring any changes in views and practice around advanced airway management as a result of participating in the trial; assessing experiences of trial training and enrolling critically unwell patients without consent, and exploring the barriers and facilitators for trial participation and the views of paramedics on the future role of advanced airway management during OHCA.Results and conclusionsThe study is in the analysis phase and is due to complete and report by the 31st January 2019.

scholarly journals Effect of chicory inulin-type fructan–containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial

2020 ◽  
Vol 111 (6) ◽  
pp. 1286-1296 ◽  
Author(s):  
Raylene A Reimer ◽  
Adriana Soto-Vaca ◽  
Alissa C Nicolucci ◽  
Shyamchand Mayengbam ◽  
Heekuk Park ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Dietary Fiber ◽  
Low Dose ◽  
Healthy Adults ◽  
Control Group ◽  
Fiber Intake ◽  
Moderate Dose ◽  
Double Blind ◽  
Dietary Fiber Intake ◽  
Gi Symptoms

Abstract Background The low intake of dietary fiber compared to recommended amounts has been referred to as the dietary fiber gap. The addition of fiber to snack foods could favorably alter gut microbiota and help individuals meet intake recommendations. Objectives Our objective was to examine the effect of low- and moderate-dose fiber-containing snack bars, comprising mainly chicory root inulin-type fructans (ITF), on gut microbiota in healthy adults with habitual low dietary fiber intake using 16S ribosomal RNA–based approaches. Methods In 2 separate 4-wk, placebo-controlled, double-blind, crossover trials, 50 healthy adults with low dietary fiber intake were randomly assigned to receive isocaloric snack bars of either moderate-dose fiber (7 g/d) or control in Trial 1 (n = 25) or low-dose fiber (3 g/d) or control in Trial 2 (n = 25), with 4-wk washout periods. Fecal microbiota composition and inferred function, fecal SCFA concentration, gastrointestinal (GI) symptoms, dietary intake, and quality of life were measured. Results Compared with the control group, the moderate-dose group showed significant differences across multiple microbial taxa, most notably an increased relative abundance of the Bifidobacterium genus from (mean ± SEM) 5.3% ± 5.9% to 18.7% ± 15.0%. With low-dose ITF, significant increases in Bifidobacterium were no longer present after correction for multiple comparisons but targeted analysis with qPCR showed a significant increase in Bifidobacterium. Predictive functional profiling identified changes in predicted function after intake of the moderate- but not the low-dose bar. Fecal SCFAs were affected by time but not treatment. There were no between-group differences in GI symptoms. Importantly, fiber intake increased significantly with the moderate- and low-dose bars. Conclusions In healthy adults, adding 3 or 7 g ITF to snack bars increased Bifidobacterium, a beneficial member of the gut microbial community. The addition of ITF to food products could help reduce the dietary fiber gap prevalent in modern life. This trial was registered at clinicaltrials.gov as NCT03042494.

Calcium phosphate supplementation increases faecal Lactobacillus spp. in a randomised trial of young adults

2016 ◽  
Vol 7 (1) ◽  
pp. 3-10 ◽  
Author(s):  
W.J. Dahl ◽  
A.L. Ford ◽  
J.A. Coppola ◽  
D. Lopez ◽  
W. Combs ◽  
...  
Keyword(s):  
Calcium Carbonate ◽  
Calcium Phosphate ◽  
Randomised Trial ◽  
Lactobacillus Rhamnosus ◽  
Crossover Design ◽  
Stool Frequency ◽  
Lactobacillus Helveticus ◽  
Double Blind ◽  
Lactobacillus Spp ◽  
Phosphate Supplementation

The aim of the studies was to determine the effects of calcium carbonate and calcium phosphate supplementation on faecal Lactobacillus spp., with and without a probiotic supplement, in healthy adults. Study 1 comprised of a randomised, double-blind, crossover design; participants (n=15) received 2 capsules/d of 250 mg elemental calcium as calcium carbonate (Ca1) and calcium phosphate (Ca2) each for 2-week periods, with 2-week baseline and washout periods. Study 2 was a randomised, double-blind, crossover design; participants (n=17) received 2 capsules/d of Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011 (probiotic) alone, the probiotic with 2 capsules/d of Ca1, and probiotic with 2 capsules/d of Ca2 each for 2-week periods with 2-week baseline and washout periods. In both studies, stools were collected during the baseline, intervention and washout periods for Lactobacillus spp. quantification and qPCR analyses. Participants completed daily questionnaires of stool frequency and compliance. In Study 1, neither calcium supplement influenced viable counts of resident Lactobacillus spp., genome equivalents of lactic acid bacteria or stool frequency. In Study 2, faecal Lactobacillus spp. counts were significantly enhanced from baseline when the probiotic was administered with Ca2 (4.83±0.30, 5.79±0.31) (P=0.02), but not with Ca1 (4.98±0.31) or with the probiotic alone (5.36±0.31, 5.55±0.29) (not significant). Detection of L. helveticus R0052 and L. rhamnosus R0011 was significantly increased with all treatments, but did not differ among treatments. There were no changes in weekly stool frequency. Calcium phosphate co-administration may increase gastrointestinal survival of orally-administered Lactobacillus spp.

Sign in / Sign up

Export Citation Format

Share Document