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Completed

NCT Number: NCT04164394

Effect of I31 Probiotic on Lactose Intolerance

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

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Key information

Conditions

Lactose Intolerance Abdominal Pain Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diarrhea Digestive System Diseases Flatulence Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Juarez de Mexico

Mexico City, 07760, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects attending Hospital Juarez de Mexico with self-reported lactose intolerance, a minimum lactose intolerance symptom score of 6 points, 20ppm during the Lactose Hydrogen Breath Test (LHBT) and providing Informed Consent.

Exclusion criteria

  • More than 10 ppm before ingestion of lactose in the Lactose Hydrogen Breath Test (LHBT). If such value was observed, the LHBT test was repeated on a 2nd day, and if >10ppm persisted, patient was excluded.
  • BMI below 18 or above 40
  • Subjects not accepting to maintain their dietary and physical activity pattern unchanged for the duration of the study
  • Subjects with congenital lactase deficiency
  • Pregnant or lactating women
  • Significant gastrointestinal disease, such as inflammatory bowel disease, coeliac disease, chronic diarrhea or gastroparesis
  • History of gastrointestinal surgery in the 6 months prior to inclusion
  • History of intestinal perforation
  • History of acute gastroenteritis, acute gastroenteritis or hospitalization in the 4 weeks prior to inclusion
  • Substance abuse
  • Untreated thyroid disorder
  • Cancer
  • Other severe diseases that in the doctor's opinion could interfere with the study
  • Known allergy to any of the components in the treatments

Treatment and study plan

Placebo

Other

Placebo treatment (maltodextrin), once daily (u.i.d)

I31 Probiotic

Dietary Supplement

I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)

Primary outcomes

  1. Overall Symptoms Score

    Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

    Total score of the "Symptoms Questionnaire for Lactose Malabsorption Screening" (Casellas et al. Dig Dis Sci 2009; 54:1059-65). Score ranges 0 to 50, where 50 represents maximum symptoms severity

Secondary outcomes

  1. Abdominal Pain subscore

    Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

    Abdominal pain Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum pain severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)

  2. Vomiting subscore

    Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

    Vomiting Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum vomiting severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)

  3. Intestinal Sounds subscore

    Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

    Intestinal Visual Analog Scale (VAS) sounds subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum intestinal sounds severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)

  4. Flatulence subscore

    Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

    Flatulence Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum flatulence severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)

  5. Lactose Hydrogen Breath Test (LHBT)

    Time frame: 3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)

    LHBT test performed with 25 gr of lactose after an overnight fast. Measurements 10 minutes before lactose ingestion and 60, 120 and 180 minutes after lactose ingestion. CO2 (Carbon Dioxide) used as control. If more than 10ppm in the measurement before ingestion of lactose, and LHBT test was rescheduled and recommendations to avoid complex carbohydrates 24h before the test were repeated. Carbon dioxide (CO2) was measured and used to adjust breath sample for non-alveolar dilution of exhaled air.

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study title

Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2019
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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