Effect of I31 Probiotic on Lactose Intolerance

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

People with lactose intolerance are unable to fully digest the sugar (lactose) in milk. As a result, they may have diarrhea, abdominal pain, gas and bloating after eating or drinking dairy products. A deficiency of lactase — an enzyme produced in your small intestine — is usually responsible for lactose intolerance. Many people have low levels of lactase but are able to digest milk products without problems. In lactose intolerance, though, lactase deficiency leads to symptoms after eating dairy foods.

I31 is a probiotic formula composed of Pediococcus acidilactici strain CECT7483 and Lactobacillus plantarum strains CECT7484 and CECT7485, previously shown to improve intestinal sensitivity in patients with Irritable Bowel Syndrome (IBS). IBS is a functional intestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits, often accompanied by bloating. Given the overlap in symptoms between IBS and lactose intolerance, it is hypothesized that I31 formula could be beneficial for individuals with lactose intolerance. ;

Study Design

Related Conditions & MeSH terms

Lactose Intolerance

Clinical Trial Details

NCT number	NCT04164394
Study type	Interventional
Source	Hospital Juarez de Mexico
Contact
Status	Completed
Phase	N/A
Start date	May 13, 2019
Completion date	December 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05100719` - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)	N/A
Completed	`NCT02518295` - β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion	N/A
Completed	`NCT00599859` - Effects of Lactose on Fecal Microflora	N/A
Completed	`NCT02636413` - Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance	Phase 4
Completed	`NCT02406469` - Effects Comparison of A1 and A2 Milk on Gastrointestinal Physiology, Symptoms and Cognitive Behavior	Phase 4
Terminated	`NCT00247806` - Prevalence of Lactose Intolerance Following Stem Cell Transplantation	Phase 1
Completed	`NCT03814668` - Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution	N/A
Completed	`NCT03860051` - Association Between Lactase Deficiency, and the Small Intestinal Microbiome in Adults.
Not yet recruiting	`NCT06107088` - Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance	N/A
Completed	`NCT02703987` - HYBRID: Hydrogen Breath Test in Lactose Digestion	N/A
Completed	`NCT00395954` - Amount of Lactose Causing Symptoms in Lactose Intolerant People	Phase 0
Completed	`NCT01593800` - The Effect of Probiotics on Lactose Intolerance	N/A
Recruiting	`NCT05668468` - A Bifido Bacteria to Improve Lactose Digestion and Tolerance	N/A
Completed	`NCT03563846` - Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects	Phase 1
Recruiting	`NCT02085889` - Fructose and Lactose Intolerance and Malabsorption in Functional Gastrointestinal Disorders
Completed	`NCT03597516` - Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance	Phase 3
Not yet recruiting	`NCT03563859` - Evaluation of Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance	Phase 3
Completed	`NCT02171403` - Comparison of the Colonic Metabolism in Patients With Lactose Intolerance and Healthy Controls	N/A
Completed	`NCT01145586` - A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia	Phase 3
Completed	`NCT02902016` - Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies	N/A