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Lactose Intolerance clinical trials

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NCT ID: NCT06301139 Completed - Clinical trials for Gastrointestinal Diseases

Goat Milk Infant Formula Comfort Study

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

In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.

NCT ID: NCT05658861 Completed - Clinical trials for Lactose Intolerance, Adult Type

Comparing the Gastric Transit of Commercial Milk and A2 Milk

Start date: June 21, 2021
Phase: N/A
Study type: Interventional

Cow'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.

NCT ID: NCT05367453 Completed - Lactose Intolerance Clinical Trials

Effect of a Probiotic With High Beta-galactosidase Activity on Patients With Lactose Intolerance

PROBIOLAC
Start date: February 22, 2021
Phase: N/A
Study type: Interventional

Lactose intolerance is a chronic disease caused by the total/partial lack of lactase production. When lactose is not properly digest, it is consumed by the microbiota. This situation presents different gastrointestinal symptoms such as meteorism, pain, bloating, diarrhoea and nausea. The dietetic treatment for this patients consists of avoiding lactose-rich foods, mainly milk and dairy products. However, nowadays exists a large diversity of lactose-free products specially focused on lactose intolerants. In this context, using B.coagulans as a probiotic in a food matrix could be an alternative for these patients, since its ability of spore forming and the production of beta-galactosidase. Based on the foregoing, the group research has design a randomized, double-blind, placebo-controlled crossover nutritional clinical trial to evaluate the effect of a regular probiotic with high production of beta-galactosidase effect over gastrointestinal syntoms of patients with lactose intolerance.

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: 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: 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.