Active clinical trials for "Lactose Intolerance"

The goal of this study is to assess the performance of the Vivante Health GIMate Breathalyzer device in diagnosing lactose malabsorption.

The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.

The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those who cannot(LNP)digest lactose. This division may help modify disease risks according to geographic population distribution. At least some of the putative mechanism of risk modification may relate to an effect of undigested lactose on lower intestinal bacteria. The effect may provide for support of beneficial microbes. The amount of lactose reaching the colon is made easier in LNP than LP subjects who have to consume larger amounts to have meaningful spillover into the lower bowel.The current study examines whether there are quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk sugar)between these 2 different phenotypic populations. Finding of differences would lend support to the notion that for some diseases LP and LNP subjects face different risks even in an area of uniform disease risk if they consume lactose (found in dairy foods). The primary end point is comparison of 4 groups of specific bacteria between LP and LNP participants before and after 2 weeks of lactose(in powder form mixed in water) consumption. Classification is based on genetic analysis and secondarily on breath hydrogen results. Results are compared within groups. The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects against each group of stool samples obtained on the first visit. Results are obtained between groups. Additional information and other secondary outcomes are to evaluate any relationship between diet intake and the 4 groups of bacteria on the first visit Another outcome will be to compare within groups any effect of lactose consumption on insulin and glucose levels within the 2 groups.

This is a single-site, double-blinded, randomized, controlled, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal physiology, symptoms and cognitive behaviour for the health people who are intolerant to traditional cow's milk.

There is increasing evidence that a number of people experience moderate milk intolerance characterised by increased gas production, bloating and abdominal cramp, which can neither be attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to the formation of bioactive peptides, one of which derived from a mutated gene variant (A1) coding for milk beta-casein has been associated with increased gastrointestinal inflammation and poor gastrointestinal function. In this study, we hypothesise that consumption of non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals.

This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut

This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal symptoms for the health people who self-reported to be lactose intolerant.

Lactose intolerance (LI), also known as lactose malabsorption is the most common type of carbohydrate malabsorption. It is associated with the inability to digest lactose into its constituents, glucose and galactose, due to low levels of lactase enzyme activity (1-2). At birth, lactase activity is at the highest and it declines after weaning (1-2). The unabsorbed lactose is metabolized by colonic bacteria to produce gas (hydrogen (H2) and methane (CH4)) and short chain fatty acids. Symptoms related to LI appear 30 minutes to 2 hours after consumption of food products containing lactose. Related symptoms include: bloating, cramping, flatulence and loose stool (1-2, 17-18). Highest rates of LI are found in the Asian populations, Native Americans and African Americans (60-100%), while lowest rates are found in people of northern European origin (including northern Americans) (3-4). The diagnosis of LI based on patients' symptoms is sometimes problematic, since these symptoms are not specific and may differ from one patient to another. Breath hydrogen test have been advocated as the best diagnostic tool for the assessment of LI (15-16). During the test, subjects are sampled for hydrogen levels of breath samples at base line and every 30 minutes after the administration of 50 grams of oral lactose, for a total period of 180 minutes. A breath sample with > 20 ppm above baseline is considered positive for LI (15-16). There are no established treatments for LI, other than almost complete avoidance of lactose rich dairy products. Avoidance of dairy products is a major concern since its outcome may result in a dietary calcium intake that is well below recommended dose of 1,000 mg per day for men and women and 1,300 mg for adolescents (8-10). For this reason different course of action needs to be considered instead of a complete exclusion of dairy products by LI patients. Two possible interventions in the case of LI are the supplement of commercially available lactase (tablets) or the addition of probiotics. The consumption of lactase enzyme as a food supplement may assist in restoring adequate levels of the enzyme needed for hydrolysis of lactose, especially for patients with low, or non existent levels of lactase. On the other hand, lactase products are problematic since not all lactase preparations are of the same concentration. Moreover, it is difficult to asses the amount of lactase tablets needed in order do fully hydrolyze lactose in each dairy mill (14). Probiotics are live microorganisms that are commonly used in order to prevent or treat a disease. The current definition by the Food and Drug Administration and the World Health Organization is "Live microorganisms which, when administered in adequate amounts, confer a health benefit on the host." These microorganisms are a heterogeneous group, they are nonpathogenic and produce beta- galactosidase or lactase intracellularly that may assist in the digestion of lactose (11). Studies have shown that people with lactose intolerance tolerated the lactose in yogurt better than the same amount of lactose in milk. The assumption was that the presence of lactase producing bacteria in the yogurt, especially Lactobacillus acidophilus, contributed to the digestion and absorption of lactose (5-6, 13). It was also found that the presence of Lactobacillus bulgaricus and Streptococcus thermophilus alleviate lactose intolerance through their ability to produce lactase enzyme (7). Finally, in another study it was found that consumption of milk containing Bifidobacterium longum resulted in significantly less hydrogen production and flatulence as compared to the consumption of control pasteurized milk (12). Based on the mentioned data, the investigators speculate that the administration of probiotics may assist with the consumption of dairy products containing lactose. Therefore, the aim of this study is to evaluate the effect of probiotics on patients with LI.

Study objectives: Primary: Difference in breath hydrogen concentration (BHC, ppm) in lactase and probiotic groups compared to placebo, measured by the incremental area under curve (iAUC) analysis Non-inferiority in breath hydrogen concentration (BHC, ppm) of probiotic group compared to lactase group, measured by the incremental area under curve (iAUC) analysis Secondary: Breath test Breath hydrogen peak value (ppm) in lactase and probiotic groups compared to placebo Cumulative breath hydrogen (ppm) in lactase and probiotic groups compared to placebo Acute gastrointestinal symptoms (severity or presence/absence to be defined on a Likert scale) in lactase and probiotic groups compared to placebo Abdominal pain Flatulence Bloating Nausea and vomiting Bowel movements and diarrhea (if present, stool consistency to be defined on Bristol stool scale and number of bowel movements to be recorded) Ancillary: Baseline fasting BHC (ppm) Breath methane CH4 (ppm) Breath carbon dioxide CO2 (ppm) Probiotic identification in feces before each lactose challenge by molecular methods Gene test to determine lactase deficiency status at screening (following SNP variants to be screened: 13910*C (Europe, Central Asia, commonly used) -22018*G (Europe), -13915*T (Saudi-Arabia, Africa), -14010*G (Africa), -13907*C (Africa))

Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease. However, milk contains disaccharide lactose, which may cause gastrointestinal problems in those adults with poor digestion. Recent studies have shown that subjects with intolerance to lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption to it. Lactose maldigestion would not be a restricting factor in milk intake. In general, the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal flora profile. But there are few studies evaluating effect of milk intake on health of people with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.