Status:
COMPLETED
Effect of a Probiotic With High Beta-galactosidase Activity on Patients With Lactose Intolerance
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Go Fruselva, S.L.
Conditions:
Lactose Intolerance
Eligibility:
All Genders
18-65 years
Phase:
NA
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 differen...
Detailed Description
Probiotics are defined by Food and Agriculture Organization of the United Nations and World Health Organization (FAO/WHO) as "living microorganisms that, properly administrated, confers a benefit on i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- Patients with gastrointestinal surgery (last 6 months)
- Patients with surgery for weight loss (gastric bypass, lap band)
- Patients on anticoagulation therapy
- Patients with diagnosed lactase congenital deficit
- Patients with fructose intolerance
- Patients with allergies to cow's milk protein
- Patients with intolerance to any of the ingredients of the clinical trial products.
- Patients with excessive exercise (\>2h, thrice per week)
- Patients undergoing antibiotic treatment (last month)
- Patients with high consume of supplements (antioxidants, omega-3, vitamins, minerals, prebiotics) (last 2 weeks)
- Patients with regular consumption of fermented foods (≥3 times per week, such as yogurt, kefir, blue cheese) or probiotics.
- Patients with alcoholic consumptions \> 30 g/d (i.e. 300 mL of wine, 3 bottles of beer, a cup of whiskey (75 mL) or similar distilled alcoholic beverages)
- Patients with regular use of laxatives (\>2 per week)
- Patients participating in more clinical trials at the same time.
- Pregnant/breastfeeding women
- Women with regular use of contraception treatment
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05367453
Start Date
February 22 2021
End Date
February 9 2022
Last Update
May 10 2022
Active Locations (1)
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1
Institute for Health Research IdiPAZ
Madrid, Spain, 28046