Compendium of the most significant studies with reference to properties, intake, effects.

BACKGROUND: Primary hypolactasia is a common condition where a reduced lactase activity in the intestinal mucosa is present. The presence of abdominal symptoms due to poor absorption of lactose, which are present in some cases, is a characteristic of lactose intolerance. OBJECTIVE: Evaluate the efficacy of a product containing exogenous lactase in tablet form compared to a reference product with proven effectiveness in patients with lactose intolerance. METHODS: Multicentre, randomized, parallel group, single-blind, comparative non-inferiority study. One hundred twenty-nine (129) adult lactose intolerance patients with hydrogen breath test results consistent with a diagnosis of hypolactasia were randomly assigned to receive the experimental product (Perlatte(r) - Eurofarma Laboratórios S.A.) or the reference product (Lactaid(r) - McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days. RESULTS:
Data from 128 patients who actually received the studied treatments were analysed (66 were treated with the experimental product and 62 with the reference product). The two groups presented with similar baseline clinical and demographic data. Mean exhaled hydrogen concentration tested at 90 minutes after the last treatment (Day 42) was significantly lower in the experimental product treated group (17±18 ppm versus 34±47 ppm) in the per protocol population. The difference between the means of the two groups was -17 ppm (95% confidence interval [95% CI]: -31.03; -3.17). The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). Secondary efficacy analyses confirmed that the treatments were similar (per protocol and intention to treat population). The tolerability was excellent in both groups, and there were no reports of serious adverse events related to the study treatment. CONCLUSION: The experimental product was non-inferior to the reference product, indicating that it was an effective replacement therapy for endogenous lactase in lactose intolerance patients (1).

BACKGROUND: There are no studies on systemic sclerosis (SSc) assessing the relationship between food intake, especially lactose, and gastrointestinal dysfunction. AIM: To determine the prevalence of lactose malabsorption, using lactose breath test, in patients with SSc. To evaluate the correlation between lactose malabsorption and gastrointestinal involvement. To predict which SSc patients exhibit lactose malabsorption. METHODS: Seventy-seven consecutive Caucasian patients with SSc and 20 control subjects underwent lactose breath test. All patients also completed a questionnaire on digestive symptoms, and a global symptom score (GSS) was calculated. RESULTS: The prevalence of lactose malabsorption was higher in SSc patients than in controls (44.3% vs. 10%; P = 0.004). We observed a marked correlation between the presence of lactose malabsorption and: higher values of GSS (P < 0.0001); severe oesophageal (P = 0.018) and small intestinal (P = 0.04) motor disorders; and joint involvement (P = 0.019). Furthermore, in SSc patients with symptomatic lactose malabsorption, the median value of GSS of digestive symptoms was lower after initiation of lactose-free diet (P < 0.0001). CONCLUSIONS: Our study underscores the fact that lactose malabsorption often occurs in patients with systemic sclerosis. Furthermore, our findings highlight the fact that lactose breath test is a helpful, noninvasive method, by identifying the group of patients with systemic sclerosis with symptomatic lactose malabsorption that may benefit from a reduction in lactose intake (2).

BACKGROUND: Type 2 diabetes mellitus is chronic metabolic disorder. Common gastrointestinal symptoms in type 2 diabetic patients are flatulence, constipation and/or diarrhea. Reason for these may be lactose intolerance leading to change in vitamin D, Calcium and parathyroid hormone which further regulate bone mineralization. AIM: To measure lactose intolerance, vitamin D, calcium and parathyroid hormone in type 2 diabetic patients. MATERIAL AND METHODS: 150 type 2 diabetic patients attending Endocrinology Clinic in PGI, Chandigarh and 150 age and sex matched healthy controls were enrolled. Lactose intolerance was measured using non-invasive lactose breath test. 25-hydroxyvitamin D (total) and Parathyroid hormone were measured in plasma using immunoassay. Serum calcium was measured using auto analyzer. T score was recorded from DXA scan for bone mineral density measurement. RESULTS: Lactose intolerance was observed significantly higher (p<0.001) diabetic patients (59.3%) as compared to controls (42%). Levels of plasma 25-OH vitamin D (total), parathyroid hormone and serum calcium were significantly lower in patients as compared to controls. Furthermore, levels of plasma 25-OH vitamin D (total), parathyroid hormone and serum calcium were more decreased in lactose intolerant diabetic patients than lactose tolerant patients. Sixty seven percent (67%) of diabetic patients suffered from osteoporosis and 20% of controls. Eighty percent (80%) diabetic patients and 16% controls with osteoporosis suffered from lactose intolerance. CONCLUSION: From this study we can conclude that measurement of lactose intolerance using non-invasive lactose breath test is suggested for type 2 diabetic patients along with timely measurement of 25-OH vitamin D (total), calcium and parathyroid hormone levels (3).

Lactose and saccharose have the same molecular formula; however, the arrangement of their atoms is different. A major difference between lactose and saccharose with regard to digestion and processing is that it is not uncommon for individuals to be lactose intolerant (around two thirds of the population has a limited ability to digest lactose after infancy), but it is rather unlikely to be saccharose intolerant. The pharmaceutical industry uses lactose and saccharose as inactive ingredients of drugs to help form tablets because of their excellent compressibility properties. Some patients with severe lactose intolerance may experience symptoms of many allergic reactions after taking medicine that contains this substance. People who are specifically "allergic" to lactose (not just lactose intolerant) should not use tablets containing this ingredient. Fourier Transform Infrared (FTIR) spectroscopy has a unique chemical fingerprinting capability and plays a significant important role in the identification and characterization of analyzed samples and hence has been widely used in pharmaceutical science. However, a typical FTIR spectrum collected from tablets contains a myriad of valuable information hidden in a family of tiny peaks. Powerful multivariate spectral data processing can transform FTIR spectroscopy into an ideal tool for high volume, rapid screening and characterization of even minor tablet components. In this paper a method for distinction between FTIR spectra collected for tablets with or without lactose is presented. The results seem to indicate that the success of identifying one component in FTIR spectra collected for pharmaceutical composition (that is tablet) is largely dependent on the choice of the chemometric technique applied (4).

Lactose intolerance related to primary or secondary lactase deficiency is characterized by abdominal pain and distension, borborygmi, flatus, and diarrhea induced by lactose in dairy products. The biological mechanism and lactose malabsorption is established and several investigations are available, including genetic, endoscopic and physiological tests. Lactose intolerance depends not only on the expression of lactase but also on the dose of lactose, intestinal flora, gastrointestinal motility, small intestinal bacterial overgrowth and sensitivity of the gastrointestinal tract to the generation of gas and other fermentation products of lactose digestion. Treatment of lactose intolerance can include lactose-reduced diet and enzyme replacement. This is effective if symptoms are only related to dairy products; however, lactose intolerance can be part of a wider intolerance to variably absorbed, fermentable oligo-, di-, monosaccharides and polyols (FODMAPs). This is present in at least half of patients with irritable bowel syndrome (IBS) and this group requires not only restriction of lactose intake but also a low FODMAP diet to improve gastrointestinal complaints. The long-term effects of a dairy-free, low FODMAPs diet on nutritional health and the fecal microbiome are not well defined. This review summarizes recent advances in our understanding of the genetic basis, biological mechanism, diagnosis and dietary management of lactose intolerance (5).

References_________________________________________________________________________

(1) Francesconi CF, Machado MB, Steinwurz F, Nones RB, Quilici FA, Catapani WR, Miszputen SJ, Bafutto M. ORAL ADMINISTRATION OF EXOGENOUS LACTASE IN TABLETS FOR PATIENTS DIAGNOSED WITH LACTOSE INTOLERANCE DUE TO PRIMARY HYPOLACTASIA. Arq Gastroenterol. 2016 Oct-Dec;53(4):228-234. doi: 10.1590/S0004-28032016000400004. 

(2) Marie I, Leroi AM, Gourcerol G, Levesque H, Menard JF, Ducrotte P. Lactose malabsorption in systemic sclerosis. Aliment Pharmacol Ther. 2016 Nov;44(10):1123-1133. doi: 10.1111/apt.13810.

(3) Rana S, Morya RK, Malik A, Bhadada SK, Sachdeva N, Sharma G. A relationship between vitamin D, parathyroid hormone, calcium levels and lactose intolerance in type 2 diabetic patients and healthy subjects. Clin Chim Acta. 2016 Nov 1;462:174-177. doi: 10.1016/j.cca.2016.09.009.

(4) Banas A, Banas K, Kalaiselvi SMP, Pawlicki B, Kwiatek WM, Breese MBH. Is it possible to find presence of lactose in pharmaceuticals? - Preliminary studies by ATR-FTIR spectroscopy and chemometrics. Spectrochim Acta A Mol Biomol Spectrosc. 2017 Jan 15;171:280-286. doi: 10.1016/j.saa.2016.08.003.

(5) Deng Y, Misselwitz B, Dai N, Fox M. Lactose Intolerance in Adults: Biological Mechanism and Dietary Management. Nutrients. 2015 Sep 18;7(9):8020-35. doi: 10.3390/nu7095380.