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

NCT05367453 | Completed DMC

• 1 other identifier: HULP 5758
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal symptoms

  The questionnaire developed by Casellas et al. 2009 on the specific symptoms of lactose intolerance. The patient will indicate on a scale of 1 to 10 the intensity of the following gastrointestinal symptoms: abdominal pain, bloating, flatulence, diarrhea and cramps. The scale indicates the total absence of symptoms (0) or their severe presence (10).

  3 months

Secondary Outcomes (6)

• Sensory perception

  3 months

• Physical activity

  3 months

• Waist circumference

  3 months

• Body weight

  3 months

• Digestive Symptoms Questionnaire (GSRS)

  3 months

Study Arms (2)

Lactase

ACTIVE COMPARATOR

Volunteers will consume once a day for 1 month a tropical juice (orange, mango, pineapple and turmeric) and a lactase tablet

Other: a Tropical juice with no probiotics; Other: lactase tablet

Probiotic

EXPERIMENTAL

Volunteers will consume once a day for 1 month the probiotic added to a liquid matrix (tropical juice) and and a placebo tablet (cornstarch)

Dietary Supplement: Tropical juice with probiotics (B.coagulans); Other: placebo tablet (cornstarch)

Interventions

Tropical juice with probiotics (B.coagulans) DIETARY_SUPPLEMENT

Once a day during all the intervention phase, volunteers with lactose intolerance should allow the spore-forming ability of B. coagulans in order to digest lactase from dairy products through regular consumption of Tropical juice with probiotics (B.coagulans)

Probiotic

a Tropical juice with no probiotics OTHER

Once a day during all the intervention phase, volunteers with lactose intolerance should consume a Tropical juice with no probiotics

Lactase

lactase tablet OTHER

lactase tablet

Lactase

placebo tablet (cornstarch) OTHER

placebo tablet (cornstarch)

Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women at 18-65 years of age
• Body Mass Index (BMI) ≥18,5 and \<35 kg/m2
• Patients with lactose intolerance
• Patients with a social environment that do not prevent the clinical trial fulfillment
• Patients with proper cultural level and good understanding level about the clinical trial
• Patients that have voluntarily agreed to participate in the clinical trial, giving the written informed consent.

You may not qualify if:

• Patients with Body Mass Index (BMI) \<18,5 or ≥35 kg/m2
• Patients with Diabetes Mellitus type 1 (DMI) or Diabetes Mellitus type 2 (DMII) with no treatment
• Patients diagnosed with metabolic syndrome
• Patients diagnosed with hyperthyroidism/hypothyroidism with no treatment
• Patients with eating disorders
• Patients with diagnosed mental disorder (dementia, any cognitive function decline)
• Patients with celiac disease
• Patients with uncontrolled high blood pressure (last 2 months)
• Patients with serious disease (ascites, cirrhosis, kidney failure, heart failure, pseudomembranous colitis, lung failure, cancer, etc.)
• Patients with chronic inflammatory bowel disease (gastritis, ulcerative colitis, irritable bowel syndrome, Crohn disease, bowel perforation, etc.)
• Patients with glomerular filtration rate \<90 ml/min/1,73 m2
• Patients with auto-immune diseases
• Patients undergoing corticosteroids or immunosuppressive treatment (last 12 months)
• Patients with recent episodes of nausea, vomits or diarrhoea (last 2 weeks)
• Patients with major surgery (last 3 months)

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Go Fruselva, S.L.: collaborator

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Probiotics; Lactase; Starch

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 10, 2022
• Study Start: February 22, 2021
• Primary Completion: November 30, 2021
• Study Completion: February 9, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)