The effects of loperamide, or loperamide plus simethicone, on the distribution of gut water as assessed by <scp>MRI</scp> in a mannitol model of secretory diarrhoea

Placidi, E.; Marciani, Luca; Hoad, Caroline L.; Napolitano, Antonio; Garsed, Klara; Pritchard, Susan E.; Cox, Eleanor; Costigan, Carolyn; Spiller, Robin C.; Gowland, Penny A.

doi:10.1111/j.1365-2036.2012.05127.x

Cited by 26 publications

(30 citation statements)

References 22 publications

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“…A loperamide–simeticone caplet (capsule-shaped tablet) formulation was subsequently developed, but there are no clinical data on the efficacy of this formulation. More recently, a comparison of loperamide–simeticone with loperamide alone using a mannitol model of secretory diarrhoea demonstrated that both forms of loperamide significantly reduced small bowel water content, but that the loperamide–simeticone combination also significantly reduced ascending colon water content [11]. This finding is consistent with the greater clinical efficacy found with the combination, although a higher than usual dose was used in this study.…”

Section: Introductionsupporting

confidence: 86%

Comparison of Two Forms of Loperamide–Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial

et al. 2015

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BackgroundAcute diarrhoea is a frequent health problem in both travellers and residents that has a social and economic impact. This study compared the efficacy and tolerability of two loperamide–simeticone formulations and a Saccharomyces boulardii capsule as symptomatic treatment.MethodsThis was a prospective, randomised, single (investigator)-blind, three-arm, parallel group, non-inferiority clinical trial in adult subjects with acute diarrhoea at clinics in Mexico and India, with allocation to a loperamide–simeticone 2/125 mg caplet or chewable tablet (maximum eight in 48 h) or S. boulardii (250 mg twice daily for 5 days).Outcome MeasuresThe primary outcome measure was the number of unformed stools between 0 and 24 h following the initial dose of study medication (NUS 0–24). The secondary outcome measures were time to last unformed stool (TLUS), time to complete relief of diarrhoea (TCRD), time to complete relief of abdominal discomfort (TCRAD) and the subject’s evaluation of treatment effectiveness. Follow-up endpoints at 7 days were feeling of complete wellness; stool passed since final study visit; and continued or recurrent diarrhoea.SubjectsIn this study, 415 subjects were randomised to either a loperamide–simeticone caplet (n = 139), loperamide–simeticone chewable tablet (n = 139) or S. boulardii capsule (n = 137) and were included in the intention-to-treat analysis.ResultsWith regards to mean NUS 0–24, the loperamide–simeticone caplet was non-inferior to loperamide–simeticone tablets (3.4 vs. 3.3; one-sided 97.5 % confidence interval ≤0.5), with both significantly lower than S. boulardii (4.3; p < 0.001). The loperamide–simeticone groups had a shorter median TLUS [14.9 and 14.0 vs. 28.5 h (loperamide–simeticone caplet and chewable tablet groups, respectively, vs. S. boulardii); p < 0.001], TCRD (26.0 and 26.0 vs. 45.8 h; p < 0.001) and TCRAD (12.2 and 12.0 vs. 23.9 h; p < 0.005) than S. boulardii. Treatment effectiveness for overall illness, diarrhoea and abdominal discomfort relief was greater (p < 0.001) in the loperamide–simeticone groups than with S. boulardii. At 7-day follow-up most subjects reported passing stool at least once since the final study visit (loperamide–simeticone caplet 94.1 %, loperamide–simeticone chewable tablet 94.8 %, S. boulardii 97.0 %), did not experience continued or recurrent diarrhoea [loperamide–simeticone caplet 3.7 % (p < 0.03 vs. S. boulardii), loperamide–simeticone chewable tablet 3.7 %, S. boulardii 5.7 %] and felt completely well [loperamide–simeticone caplet 96.3 % (p < 0.02 vs. S. boulardii), loperamide–simeticone chewable tablet 96.3 % (p < 0.02 vs. S. boulardii), S. boulardii 88.6 %]. All treatments were well-tolerated with few adverse events.ConclusionsThe loperamide–simeticone caplet was non-inferior to the original loperamide–simeticone chewable tablet formulation; both formulations can be expected to demonstrate similar clinical efficacy in the relief of symptoms of acute diarrhoea. Both loperamide–simeticone formulations were superior to the S. boulardii c...

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Section: Introductionsupporting

confidence: 86%

Comparison of Two Forms of Loperamide–Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial

et al. 2015

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“…Previous work using mannitol and glucose (18) indicated that a 43% increase in postprandial SBWC could be detected with α=0.05 and 90% power using n =12. We studied five more to allow for dropouts and incomplete scans.…”

Section: Methodsmentioning

confidence: 95%

“…This is likely because of variance in individual severity of malabsorption and bacterial fermentation of malabsorbed carbohydrate. Although the impact of oral ingestion of some FODMAPs (e.g., lactose (17) and mannitol (18) on increasing small bowel water has been demonstrated using a range of techniques, as has their malabsorption using breath hydrogen, it is desirable to link these events and understand more about the underlying mechanism. The ultimate aim would be to define the mode of action of the diet and hopefully to simplify and tailor it better to individual patients.…”

Section: Introductionmentioning

confidence: 99%

Differential Effects of FODMAPs (Fermentable Oligo-, Di-, Mono-Saccharides and Polyols) on Small and Large Intestinal Contents in Healthy Subjects Shown by MRI

Murray

Wilkinson‐Smith

Hoad

et al. 2014

American Journal of Gastroenterology

303

259

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OBJECTIVES:The objective of this study was to investigate whether ingestion of fructose and fructans (such as inulin) can exacerbate irritable bowel syndrome (IBS) symptoms. The aim was to better understand the origin of these symptoms by magnetic resonance imaging (MRI) of the gut. METHODS: A total of 16 healthy volunteers participated in a four-way, randomized, single-blind, crossover study in which they consumed 500 ml of water containing 40 g of either glucose, fructose, inulin, or a 1:1 mixture of 40 g glucose and 40 g fructose. MRI scans were performed hourly for 5 h, assessing the volume of gastric contents, small bowel water content (SBWC), and colonic gas. Breath hydrogen (H2) was measured and symptoms recorded after each scan.RESULTS:Data are reported as mean (s.d.) (95% CI) when normally distributed and median (range) when not. Fructose increased area under the curve (AUC) from 0–5 h of SBWC to 71 (23) l/min, significantly greater than for glucose at 36 (11–132) l/min (P<0.001), whereas AUC SBWC after inulin, 33 (17–106) l/min, was no different from that after glucose. Adding glucose to fructose decreased AUC SBWC to 55 (28) l/min (P=0.08) vs. fructose. Inulin substantially increased AUC colonic gas to 33 (20) l/min, significantly greater than glucose and glucose+fructose (both P<0.05). Breath H2 rose more with inulin than with fructose. Glucose when combined with fructose significantly reduced breath H2 by 7,700 (3,121–12,300) p.p.m./min relative to fructose alone (P<0.01, n=13).CONCLUSIONS:Fructose but not inulin distends the small bowel with water. Adding glucose to fructose reduces the effect of fructose on SBWC and breath hydrogen. Inulin distends the colon with gas more than fructose, but causes few symptoms in healthy volunteers.

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“…One of the most commonly used agents is loperamide, which slows transit by decreasing the tone of the longitudinal muscles and increasing the tone of circular smooth muscles of the intestinal wall [112]. This increases the time substances remain in the intestines, allowing for more water to be absorbed.…”

Section: Pathophysiology Of Selected Side-effects (Involved Targets) mentioning

confidence: 99%

Understanding and managing toxicities of vascular endothelial growth factor (VEGF) inhibitors

Schmidinger

2013

European Journal of Cancer Supplements

118

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The effects of loperamide, or loperamide plus simethicone, on the distribution of gut water as assessed by MRI in a mannitol model of secretory diarrhoea

Cited by 26 publications

References 22 publications

Comparison of Two Forms of Loperamide–Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial

Comparison of Two Forms of Loperamide–Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial

Differential Effects of FODMAPs (Fermentable Oligo-, Di-, Mono-Saccharides and Polyols) on Small and Large Intestinal Contents in Healthy Subjects Shown by MRI

Understanding and managing toxicities of vascular endothelial growth factor (VEGF) inhibitors

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