Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME...
Irritable Bowel SyndromeIrritable bowel syndrome (IBS) is a frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or con-sistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. The underlying pathophysiology remains obscure, although several pathways have been proposed. Low-grade immune activation, visceral hypersensitivity, alteration in gut microbiome have all been reported (Mearin 2016). As diet exerts an impact on all these pathophysiological mechanisms, the role of dietary intervention receives spe-cial attention, with special interest in the role played by so-called fermentable oligo-, di-, monosac-charides and polyols (FODMAPs). Multiple studies indicated the beneficial effects of the low FODMAP diet in at least part of the patients (Halmos 2014, Eswaran 2016, Staudacher 2017). As a disaccharide, lactose is part of the FODMAPs. Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fat-ty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. In patients suffering from LI, these pathophysiologi-cal mechanisms generate symptoms such as abdominal pain and cramps, flatulence, diarrhea, in-creased bowel sounds, among others, similar to the mechanisms by which FODMAPs induce symp-toms of IBS. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with such symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated to alleviate symptoms. While the earlier-mentioned studies investigated symptomatic improvement by the low FODMAP diet, it remains uncertain whether this restrictive diet remains beneficial in patients without evidence of LM. In a recent study the low FODMAP diet and LFD provided comparable improvement in symptom severity (Krieger-Grübel 2020). This study aims to: Assess the improvement in IBS symptoms and quality of life (QOL) by a low FODMAP di-et when lactose malabsorption has been previously excluded; Compare the improvement in IBS symptoms and QOL obtained by a low FODMAP diet to a lactose free diet (data from the PreVaIL study).
Comparing the Inflammation, Maldigestion and Symptoms Due to Commercial Milk and A2 Milk
Lactose IntoleranceCow's milk contains two types of β-casein: A1 and A2. It is evident from human clinical trials that milk with A1 protein produces more hydrogen and symptoms of lactose intolerance. A pro-inflammatory μ-opioid peptide BCM-7 is released from A1 but not from A2. Milk containing A1 β-casein produced more inflammatory markers than A2 β-casein. This is a double-blinded, randomized, controlled trial conducted to determine if A1 beta-casein containing milk causes acute effects on inflammatory markers following a single milk feeding, as compared to milk containing only A2 beta-casein.
A Bifido Bacteria to Improve Lactose Digestion and Tolerance
Lactose IntoleranceWe want to determine if feeding a bifido bacteria that readily digests lactose and galactooligosacharides improves lactose digestion and tolerance through alteration of the microbiome.
Comparing the Adaptation of Commercial Milk and A2 Milk in Lactose Maldigesters
Lactose IntoleranceCow's milk contains two types of β-casein: A1 and A2. It is evident from human clinical trials that milk with A1 protein produces more hydrogen and symptoms of lactose intolerance. A pro-inflammatory μ-opioid peptide BCM-7 is released from A1 but not from A2. Milk containing A1 β-casein produced more inflammatory markers than A2 β-casein. This is a double-blinded, randomized, controlled trial conducted to determine if there are changes in inflammatory markers following two weeks of milk feeding, due to milk containing A1 and A2 beta-casein as compared to milk containing only A2 beta-casein.
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
Irritable Bowel SyndromeLactose Intolerance1 moreIrritable bowel syndrome (IBS) is a functional gastrointestinal disease. There is no well-defined pharmacological treatment. This clinical trial is a prospective, double-blind, two-armed randomized controlled, single-center trial. It is created to examine the role of IBS in patients with lactose intolerance. IBS patients undergo lactose H2 breath test (LHBT) and lactose tolerance test (LTT). Those with positive LTT and LHBT will be randomized into two groups: alverine-citrate + simethicone and lactase group (1) or alverin-citrate + simethicone with the placebo group (2). The goal of this study is to compare the lactase enzyme with placebo in IBS patients with lactose intolerance.
Comparing the Gastric Transit of Commercial Milk and A2 Milk
Lactose IntoleranceAdult TypeCow's milk contains two types of β-casein: A1 and A2. The μ-opioid peptide BCM-7 is released from A1 but not from A2. BCM-7 is associated with slower gastrointestinal transit and hence increased gastrointestinal transit times. Lactose maldigesters reported an increase in abdominal pain due to consumption of milk containing A1 beta-casein as compared to milk containing only A2 beta-casein. The hypothesis of this study is that the differential abdominal pain is due to the differential gastric transit. This is a double-blinded, randomized, controlled trial conducted to determine if the transit of A1 β-casein milk is modified in the stomach as compared to milk with only A2 β-casein.
Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance
Lactose IntoleranceRP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose...
Lactose IntoleranceThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.
Effect of I31 Probiotic on Lactose Intolerance
Lactose IntoleranceThis randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia...
HypolactasiaThe study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.