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Lactose Breath Hydrogen Test

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61. Appropriate Use Criteria: Imaging of the Abdomen and Pelvis

Description and Application of the Guidelines 5 Administrative Guidelines 6 Ordering of Multiple Studies 6 Simultaneous Ordering of Multiple Studies 6 Repeated Imaging 6 Pre-Test Requirements 7 History 7 Imaging of the Abdomen and Pelvis 8 General Information/Overview 8 Scope 8 Technology Considerations 8 Definitions 9 Clinical Indications 11 General Abdominal and Pelvic Indications 11 Congenital and developmental conditions 11 Infectious and inflammatory conditions – not otherwise referenced 11 Trauma 12 (...) preference or quality concerns ? Repeated imaging of the same anatomic area (MRI or CT) based on persistent symptoms with no clinical change, treatment, or intervention since the previous study Imaging of the Abdomen and Pelvis Copyright © 2019. AIM Specialty Health. All Rights Reserved. 7 ? Repeated imaging of the same anatomical area by different providers for the same member over a short period of time Pre-Test Requirements Critical to any finding of clinical appropriateness under the guidelines

2019 AIM Specialty Health

62. Lactase deficiency

enteritis/gastroenteritis comorbid predisposing disease history of irritable bowel syndrome diagnosis Diagnostic investigations trial of dietary lactose elimination FBC lactose hydrogen breath test stool culture faecal pH faecal reducing substance/sugar lactose tolerance test small bowel biopsy genotyping 13C-labelled lactose breath test Treatment algorithm ACUTE Contributors Authors Academic Neuro-Gastroenterologist University College London Consultant Gastroenterologist University College Hospital (...) Lactase deficiency Lactase deficiency - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Lactase deficiency Last reviewed: February 2019 Last updated: November 2018 Summary Lactose intolerance is characterised by reduced lactase concentration in the mucosal brush border of the small intestine (also known as hypolactasia). It exists in four distinct forms: primary, secondary, congenital, and developmental. Symptoms can

2017 BMJ Best Practice

63. Dimethyl fumarate (Skilarence) - plaque psoriasis

of quantification LOCF Last observation carried forward LS mean Least square mean MAA Marketing Authorisation Application MTX Methotrexate MedDRA Medical Dictionary for Regulatory Activities MEF Monoethyl fumarate (synonym: ethyl hydrogen fumarate) MHRA Medicines & Healthcare Products Regulatory Agency MMF Monomethyl fumarate NF-?B Nuclear factor ‘kappa-light-chain-enhancer of activated B-cells’ PASI Psoriasis Area and Severity Index PBI Patient Benefit Index PBQ Patient Benefit Questionnaire PD (...) application. The applicant indicated that dimethyl fumarate was considered to be a known active substance. The application submitted is composed of administrative information, complete quality data, non- clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain test(s) or study(ies). Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/0287/2015

2017 European Medicines Agency - EPARs

64. Guidelines for the investigation of chronic diarrhoea in adults

and left colon (not rectal) to exclude microscopic colitis (Grade of evidence level 1, Strength of recommendation strong). Malabsorption ? If lactose maldigestion is suspected, we suggest hydrogen breath testing (if available) or withdrawal of dietary lactose/ carbohydrates from the diet (Grade of evidence level 3, Strength of recommendation weak). ? MR enterography is recommended for evaluation of small bowel abnormalities depending on availability (Grade of evidence level 1, Strength (...) 100% in the Han Chinese population. 158 There is a high level of concordance between the presence of this genotype and lactose malabsorption. 156 In contrast, there is no unique genotype linked with fructose or fructan malabsorption and a review of nine studies found that 25 g fructose may induce an increase in breath hydrogen in 40% of healthy subjects, but rarely induces symptoms. 153 Prospective studies have shown that self-reported dietary intolerance is a poor predictor of objective test

2018 British Society of Gastroenterology

65. Diet and the Gut

can tolerate is critical in determining its implications for health [ ]. The presence of malabsorption of lactose is commonly not associated with symptoms. It is only when lactose malabsorption induces symptoms that “lactose intolerance” can be diagnosed. Lactose hydrogen breath testing. Lactose hydrogen breath testing is currently considered to be the most cost-effective, noninvasive, and reliable measure of lactose malabsorption [ ]. The breath test usually involves consumption of 25 g or 50 g (...) of lactose, followed by measurement of breath hydrogen and methane over the following 3–4 hours. Although diagnostic guidelines vary, an increase in breath hydrogen by 20 ppm (parts per million) above baseline or in methane by 10 ppm above baseline suggests lactose malabsorption [ ]. Lactose “tolerance” test [ ]. This is a blood test for lactase deficiency, and the traditional term “tolerance” test is a misnomer. The patient consumes 50 g of lactose dissolved in water. Samples of capillary blood

2018 World Gastroenterology Organisation

66. Treatment of lactase deficiency in children's obesity with genotype c/c 13910 of lactase gene. (Abstract)

of lactase gene by real-time polymerase chain reaction, determining the level of lactose maldigestion by hydrogen breath test (HBT), estimating the insulin resistance with the HOMA-IR index in 70 obese children and 40 healthy children 6 - 18 years. Obese children with genotype C/C 13910 and lactose maldigestion (n=40) were randomized in two groups: children from group I (n=20) received an exogenous lactase preparation, and children from group II (n=20) - low-lactose diet.Results: in obese children (...) Treatment of lactase deficiency in children's obesity with genotype c/c 13910 of lactase gene. Introduction: Excess lactose in the diet of modern man causes the development of not only lactase deficiency, but it can be a factor that contributes to obesity. The aim: To study associations between obesity and genotype C/C 13910 of lactase gene (LCT) in children, to investigate the effectiveness of treatment using drug exogenous lactase and a low-lactose diet.Materials and methods: genotyping

2019 Wiadomosci lekarskie (Warsaw, Poland : 1960) Controlled trial quality: uncertain

67. Palbociclib (Ibrance) - locally advanced or metastatic breast cancer

sunlight. Samples were tested for assay and impurities. Degradation was only observed in the hydrogen peroxide and AAPH studies. No significant degradation was observed for acidic or basic conditions. In the solid state, no significant degradation was observed under elevated temperatures or light exposure. The assay and purity method for palbociclib drug substance was shown to be specific, selective and stability-indicating. The stability results indicate that the active substance manufactured (...) information, complete quality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision CW/0001/2015 on the granting of a class waiver. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3

2016 European Medicines Agency - EPARs

68. Low-FODMAP diets : irritable bowel syndrome (IBS)

diets and direct people to the Monash University webpages for additional information (see Consumer resources). Adherence to this diet may be difficult for approximately 30% of patients with an IBS that is potentially linked to FODMAPs. Conversely, convincing adherent patients who have not responded to stop the low-FODMAP diet can also be difficult. Assessing lactose absorption using hydrogen-breath-testing may help to distinguish those patients whose IBS is associated with lactose intolerance (...) . Hydrogen-breath testing, however, is not recommended for guiding clinical decisions relating to any other FODMAP. Grading NHMRC Level 2 evidence. References Halmos E, Power V, Shepherd S et al. . Gastroenterology 2014;146(1):67–75. DOI: 10.1053/j.gastro.2013.09.046. Staudacher HM, Irving PM, Lomer MCE et al. . Nat Rev Gastroenterol Hepatol 2014;11(4):256–66. DOI:10.1038/nrgastro.2013.259. Tuck CJ. Muir JG, Barret JS et al. . Expert Rev Gastroenterol Hepatol 2014;8(7):819–34. DOI: 10.1586

2014 Handbook of Non-Drug interventions (HANDI)

69. Carbon monoxide poisoning

of carboxyhaemoglobin does not disprove carbon monoxide poisoning unless the sample has been taken during or soon after exposure ended. Carbon monoxide exposure in the home has been associated with carboxyhaemoglobin concentrations as low as 2.5% in non-smokers and 5% in smokers. Lactose intolerant patients have raised hydrogen (H2) levels in their expired breath which can interfere with the reading. Basis for recommendation Basis for recommendation These recommendations are based on the Public Health England (PHE (...) problems (for example, anxiety, psychomotor dysfunction, loss of balance, changes in sleep, memory, vision, and smell). Personality changes. Management of carbon monoxide poisoning should include: Measuring exhaled carbon monoxide levels using a breath test. Taking a heparinised venous blood sample. Giving 100% oxygen using a tight fitting mask with an inflated seal until the person is asymptomatic and carboxyhaemoglobin levels are 3% or less in non-smokers, and 10% or less in smokers. Using a CO-pulse

2018 NICE Clinical Knowledge Summaries

70. Dyspepsia - proven functional

four times a day. [ ; ; ] Specialist investigations and management Specialist investigations and management Specialist investigations may include: Barium swallow or meal. Gastric scintigraphy to help confirm delayed gastric emptying, for example in people with post-prandial distress-type symptoms. Hydrogen breath tests to detect small intestinal bacterial overgrowth or lactose/fructose intolerance. Specialist management may include: Specialist Helicobacter pylori eradication regimens (...) , and depression, and managing these appropriately. Reviewing and stopping any drugs which may be exacerbating symptoms, if possible and appropriate. Testing for Helicobacter pylori infection should be arranged if the person's status is not known or uncertain. Ideally a carbon-13 urea breath test or stool antigen test should be used — ensuring the person has not taken a proton pump inhibitor (PPI) in the past 2 weeks, or antibiotics in the past 4 weeks. First-line H. pylori eradication therapy should

2018 NICE Clinical Knowledge Summaries

71. Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance

or placebo Qualified subjects randomized to daily dosing with RP-G28 or placebo Drug: RP-G28 or placebo Daily dosing Outcome Measures Go to Primary Outcome Measures : 1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge [ Time Frame: Baseline, 36 days ] Secondary Outcome Measures : Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 36 days ] Number (...) for Study: 18 Years to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male and female subjects. Female subjects must be non-pregnant and non-lactating. 18 to 64 years of age inclusive at Screening Current or recent history of intolerance to milk and other dairy products Acceptable Baseline Lactose Intolerance Symptom Scores Acceptable Result on Baseline Hydrogen Breath Test Subjects must agree to refrain from all other treatments and products

2010 Clinical Trials

72. Differential impact of lactose/lactase phenotype on colonic microflora Full Text available with Trip Pro

following lactose challenge tests, were measured.Lactose maldigesters had a mean change difference (0.72 log10 colony forming unitsg stool; P=0.04) in bifidobacteria counts compared with lactose digesters. Lactobacilli counts were increased, but not significantly. Nevertheless, reduced breath hydrogen after lactose ingestion correlated with lactobacilli (r=-0.5; P<0.001). Reduced total breath hydrogen and symptom scorestogether, with a rise in fecal enzymes after intervention, were appropriate (...) in ability to digest lactose is supported.A four-week study was performed in 23 lactose maldigesters and 18 digesters. Following two weeks of dairy food withdrawal, subjects ingested 25 g of lactose twice a day for two weeks. Stool bifidobacteria and lactobacilli counts pre- and postintervention were measured as the primary outcome. For secondary outcomes, total anaerobes, Enterobacteriaceae, beta-galactosidase and N-acetyl-beta-D-glucosaminidase activity in stool, as well as breath hydrogen and symptoms

2010 Canadian Journal of Gastroenterology

73. The effect of oral supplementation with Lactobacillus reuteri or tilactase in lactose intolerant patients: randomized trial. (Abstract)

breath test (H,-LBT).Sixty lactose intolerant patients participated in the study and were randomized to three 20 patients-treatment groups: tilactase group (tilactase 15 minutes before control H2-LBT); placebo group (placebo 15 minutes before control H2-LBT); Lactobacillus reuteri group (LR) (LR b.i.d. during 10 days before control H2-LBT). The outcomes were LBT normalization rate, and influences of treatments on both mean maximum hydrogen concentration and clinical score.LBT normalization rate (...) The effect of oral supplementation with Lactobacillus reuteri or tilactase in lactose intolerant patients: randomized trial. Lactase enzyme supplements and probiotics with high beta-galactosidase activity may be valid treatment options for the lactose intolerance. Aim of this study was to assess whether supplementation with tilactase or Lactobacillus reuteri when compared to placebo affects hydrogen breath excretion and gastrointestinal symptoms in lactose intolerant patients during lactose

2010 European review for medical and pharmacological sciences Controlled trial quality: uncertain

74. Lactose intolerance in patients with chronic functional diarrhea: the role of small intestinal bacterial overgrowth. Full Text available with Trip Pro

controls underwent a validated 20 g lactose hydrogen breath test (HBT). Patients completed also a 10 g lactulose HBT with concurrent assessment of small bowel transit by scintigraphy.Lactose malabsorption was present in 27/31 (87%) patients with CFD and 29/32 (91%) healthy controls (P = 0.708). From the patient group 14/27 (52%) had lactose intolerance and 13/27 (48%) experienced no symptoms (lactose malabsorption controls). Only 5 (17%) healthy controls reported symptoms (P < 0.01). The oro-caecal (...) Lactose intolerance in patients with chronic functional diarrhea: the role of small intestinal bacterial overgrowth. Many studies report a high prevalence of lactose intolerance in patients with functional, gastrointestinal disease.To evaluate the role of small intestinal bacterial overgrowth (SIBO) in condition of lactose intolerance and the mechanism by which SIBO may impact lactose tolerance in affected patients.Consecutive out-patients with chronic functional diarrhoea (CFD) and healthy

2010 Alimentary Pharmacology & Therapeutics

75. Comparison of efficacies between live and killed probiotics in children with lactose malabsorption. (Abstract)

Comparison of efficacies between live and killed probiotics in children with lactose malabsorption. The objective of this study was to determine the efficacy of live and killed probiotics to decrease the presence of hydrogen using the breath hydrogen test (BHT). This pretest-posttest control group design single blinded randomized study was performed in 5 government elementary schools in Tuminting subdistrict, Manado, Indonesia from March to May 2008. The study for inclusion as subjects (...) results before and 120 minutes after giving probiotic for the children taking both the live and the killed probiotic (p < 0.001). When the children taking the live and killed probiotics were compared, there was no difference in the BHT at 120 minutes of probiotic (p = 0.453) by t-test. The administration of live or killed probiotic for 2 weeks can decrease the results of a BHT in children with lactose malabsorption. No adverse reactions attributable to treatment were noted.

2010 The Southeast Asian journal of tropical medicine and public health Controlled trial quality: uncertain

76. Irritable Bowel Syndrome (IBS)

Gastroenterology Organization, 2015 WGO Global Guidelines IBS 4 • Hydrogen breath test for lactose intolerance and small-intestinal bacterial overgrowth (SIBO). Medium resource levels • History, physical examination, exclusion of alarm symptoms, consideration of psychological factors • FBC, ESR or CRP, stool studies, thyroid function • Sigmoidoscopy* Low resource levels • History, physical examination, exclusion of alarm symptoms, consideration of psychological factors • FBC, ESR, and stool examination * N.B (...) intolerance Main symptoms and/or findings: • Symptoms (bloating, flatulence, diarrhea) acutely related to consumption of milk and dairy products. • Although genetic testing can now detect lactase deficiency, this is not necessarily predictive of intolerance, which is best tested using the lactose hydrogen breath test. Indeed, a substantial proportion of individuals who lack lactase can tolerate oral lactose despite bacterial fermentation. In countries with a high prevalence of lactase deficiency

2015 World Gastroenterology Organisation

77. Aubagio (teriflunomide)

inhibitory concentration IFN: interferon IgG: immunoglobin G IgM: immunoglobin M ILD: interstitial lung disease IV: intravenous IVIVC: in vitro/in vivo correlation LS: least-squares MAA: Marketing Authorisation Application MEB: Medicines Evaluation Board MedDRA: Medical Dictionary for Regulatory Activities MRI: magnetic resonance imaging MS: multiple sclerosis MSFC: multiple sclerosis functional composite Assessment report EMA/529295/2013 Page 4/150 NCT: nerve-conduction test NOAEL: no-observable-adverse (...) -effect level OAT: organic anion transporter OATP: organic anion transporting polypeptide PCSA: potentially clinically significant abnormality PDCO: Paediatric Development Committee PFT: pulmonary function testing PIP: paediatric investigation plan PML: progressive multifocal leukoencephalopathy PPMS: primary progressive multiple sclerosis PRMS: progressive-relapsing multiple sclerosis PT: preferred term QD: once a day QOL: quality of life RA: rheumatoid arthritis RBC: red blood cell RRMS: relapsing

2013 European Medicines Agency - EPARs

78. Seebri Breezhaler - glycopyrronium bromide

carrier uptake transporters SMQ Standardized MedDRA query SOC System organ class SGRQ St Gorge Respiratory Questionnaire SMETT Sub-max constant-load cycle ergometry test ss Steady state T½ Apparent elimination half-life TDI Transition dyspnea index Tg Transgenic Tmax Time to reach maximum concentration Tio Tiotropium ULN Upper limit normal URTI Upper respiratory tract infection V Volume of distribution WBC White blood cell Seebri Breezhaler CHMP assessment report EMA/CHMP/508029/2012 Page 4/84 1 (...) , complete quality data, non- clinical and clinical data based on applicants’ own tests and studies and bibliographic literature supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/4/2008 on the granting of a product-specific waiver. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation

2012 European Medicines Agency - EPARs

79. Inlyta - axitinib

(hypromellose, titanium dioxide, lactose monohydrate, triacetin and red iron oxide). All excipients are well-known and commonly used in tablet formulations and meet the corresponding requirement of the European Pharmacopoeia, where appropriate. The compatibility of the active substance with the excipients has been investigated by performing stress studies (high temperature and humidity). The tablet core formulation was tested to confirm Inlyta CHMP assessment report Page 15/92 acceptable chemical stability (...) related gene HPLC High-performance liquid chromatography HUVEC Human umbilical vein endothelial cell IAUC initial area under the curve IC 50 Half maximal inhibitory concentration ICH International Conference on Harmonization ICSR Individual Case Safety Report IEC Independent Ethics Committee IFN-a interferon-alpha IL-2 Interleukin-2 IP Intraperitoneal IIR investigator-initiated research IRC Independent Review Committee IV Intravenous IVRS Interactive Voice Response System LFT Liver function test LOAEL

2012 European Medicines Agency - EPARs

80. Enurev Breezhaler - glycopyrronium bromide

carrier uptake transporters SMQ Standardized MedDRA query SOC System organ class SGRQ St Gorge Respiratory Questionnaire SMETT Sub-max constant-load cycle ergometry test ss Steady state T½ Apparent elimination half-life TDI Transition dyspnea index Tg Transgenic Tmax Time to reach maximum concentration Tio Tiotropium ULN Upper limit normal URTI Upper respiratory tract infection V Volume of distribution WBC White blood cell Enurev Breezhaler CHMP assessment report EMA/CHMP/508338/2012 Page 4/84 1 (...) , complete quality data, non- clinical and clinical data based on applicants’ own tests and studies and bibliographic literature supporting certain tests or studies. Information on Paediatric requirements Pursuant to Article 7 of Regulation (EC) No 1901/2006, the application included an EMA Decision P/4/2008 on the granting of a product-specific waiver. Information relating to orphan market exclusivity Similarity Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation

2012 European Medicines Agency - EPARs

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