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Lactose Intolerance clinical trials

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NCT ID: NCT04754724 Completed - Lactose Intolerance Clinical Trials

Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

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

NCT ID: NCT04531033 Completed - Lactose Intolerance Clinical Trials

Does Daily Supplementation of Lactobacillus Acidophilus MPH734, for One Week, Affect Acute (Immediate), Subacute (7 Days), and Post-treatment Discontinuation Lactose Metabolism, Gastrointestinal Symptoms, and Clinical Markers of Inflammation and Safety Compared to a Placebo

LF
Start date: August 25, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if twice or three times daily supplementation of Lactobacillus acidophilus MPH734 (Lacto-FreedomTM, or LF), for one week, affects acute (immediate), subacute (7 days), and post-treatment discontinuation (30-, 60-, and 90- day) lactose metabolism, gastrointestinal symptoms, and clinical markers of inflammation and safety compared to a placebo.

NCT ID: NCT04164394 Completed - Lactose Intolerance Clinical Trials

Effect of I31 Probiotic on Lactose Intolerance

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.

NCT ID: NCT03952988 Not yet recruiting - Lactose Intolerance Clinical Trials

Effect of B.Bifidum 900791 Intake in Adult With Hypolactasia and Lactose Intolerance

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. This situation occurs in 75% of the world population and is known as "adult primary hypolactasia" while the remaining 25% is "lactase persistent" i.e. maintains in adulthood lactase values similar to these of newborns. In subjects with hypolactasia, the intake of milk products can produce digestive symptoms, making that the affected individuals spontaneously reduce the consumption of these products and, therefore, their intake of calcium and proteins. In addition to lactose-free milk and exogenous lactase, a strategy for the intolerant subjects to continue consuming dairy products is, for example, to consume yogurt, due to the fact that the lactase of the yogurt bacteria continues to function in the intestine of the consumer, hydrolyzing lactose and decreasing the development of digestive symptoms. Similarly, many probiotic strains, such as L. acidophilus NCFM, L. casei CRL431, B. longum 401 and B. bifidum Orla Jensen 1424, express β-galactosidases that hydrolyze lactose, preventing its fermentation and the production of gases. The acute administration of these strains improves lactose tolerance. In addition, a recent study reported that dietary supplementation of intolerant subjects for 4 weeks with L. casei Shirota and B. breve Yakult reduced digestive symptoms and breath hydrogen excretion not only at the end of the period of administration of the probiotics but also 3 months after having discontinued the use of probiotics. Based on this background, the aim of this study is to determine whether the regular consumption of an ice cream with the strain B. bifidum 900791 improves lactose intolerance in hypolactasic subjects, even after the suspension of the consumption of the product. To determine if this effect is due to the adaptation of the microbiota, the investigators will also evaluate changes in the composition of the microbiota and the generation of volatile fatty acids.

NCT ID: NCT03860051 Completed - Lactose Intolerance Clinical Trials

Association Between Lactase Deficiency, and the Small Intestinal Microbiome in Adults.

Start date: November 21, 2018
Phase:
Study type: Observational

The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance.

NCT ID: NCT03814668 Completed - Lactose Intolerance Clinical Trials

Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

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))

NCT ID: NCT03597516 Completed - Lactose Intolerance Clinical Trials

Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

This 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.

NCT ID: NCT03563859 Not yet recruiting - Lactose Intolerance Clinical Trials

Evaluation of Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

Start date: June 2018
Phase: Phase 3
Study type: Interventional

Ritter Pharmaceuticals, Inc. is developing RP G28 as a treatment for Lactose Intolerance. Lactose intolerance is a syndrome of gastrointestinal symptoms resulting from a deficiency in intestinal lactase relative to the amount of lactose consumed. Efficacy of RP-G28 will be evaluated by the reduction of lactose intolerance-associated symptoms. The primary objective of this study is to assess the efficacy of RP G28 compared to placebo on symptom reduction related to lactose intolerance.

NCT ID: NCT03563846 Completed - Lactose Intolerance Clinical Trials

Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects

RP
Start date: March 9, 2018
Phase: Phase 1
Study type: Interventional

Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.

NCT ID: NCT03261856 Completed - Glucose Intolerance Clinical Trials

Clinical Utility of Breath Tests in GI

Start date: August 31, 2011
Phase:
Study type: Observational

Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative; these patients are labeled as IBS. In these patients, whether testing for carbohydrate malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear. Investigators aim to assess the prevalence of SIBO, fructose and lactose intolerance, the usefulness of breath tests, and predictive value of pre-test symptoms.