The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)

Launched by UNIVERSITY OF PECS · Oct 19, 2021

Keywords

ClinConnect Summary

The LION trial is studying how irritable bowel syndrome (IBS) affects people who are lactose intolerant—meaning their bodies struggle to digest lactose, a sugar found in milk and dairy products. The trial will look at whether a special enzyme called lactase, which helps break down lactose, can improve symptoms in IBS patients who also have lactose intolerance. Participants will undergo specific tests to confirm their lactose intolerance and IBS diagnosis. If eligible, they will be randomly assigned to receive either the lactase enzyme combined with two other medications or a placebo (a treatment that looks the same but has no active ingredients).

To be eligible for the trial, participants must be between 18 and 80 years old, have a confirmed diagnosis of IBS based on certain criteria, and show positive results on lactose tests. They also need to be in good overall health, without serious gastrointestinal disorders or other specific health issues. The trial will not begin recruiting participants just yet, but those who join can expect close monitoring and support throughout the study to see how effective the lactase treatment is for their symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age 18-80 years
• • patients diagnosed with irritable bowel syndrome based on the ROME IV. criteria
• • positive LHBT (lactose H2 breath test) and LTT (lactose tolerance test) results
• • negative abdominal ultrasound/CAT scan/MRI results within one year
• • signed the informed consent
• Exclusion Criteria:
• • organic gastroenterological disorders which can explain symptoms (e.g. positive serological screening: anti-gliadin IgG / IgA, anti-tissue transglutaminase IgG / IgA, high level of fecal calprotectin tested by endoscopy or positive colonoscopy for IBD, currently active diverticulitis
• • Alarm symptoms: fever (\> 38 Co), anaemia (Hgb \< 120 g/l), unintended weight loss (\> 4.5 kg / 3 months), gastrointestinal bleeding (hematemesis, hematochesia, melena)
• • cardiac failure (NYHA III-IV)
• • liver cirrhosis (Child-Pugh C)
• • active malignancy
• • major abdominal surgery in the history
• • pregnant or breastfeeding women
• • any circumstances which can lead to false results of LHBT and LTT: cigarette smoking or physical exercise within 2 hours before the test, ingestion of dietary fibers on the evening before the test, recent use of antibiotics, lung disease, baseline H2 concentration in the exhaled air is higher than 20 ppm, not properly treated diabetes mellitus, following lactose restricted or another special diet within 1 week prior to study enrolment (ingestion of less than 12 g lactose - less than 250 ml milk - per day)
• • small intestinal bacterial overgrowth (SIBO): if there is a rapid increase of H2 level in the exhaled air (≥20 ppm above baseline within 90 minutes), SIBO is suspected and antibiotic therapy will be started (peroral rifaximin for 5 days) after negative Helicobacter pylori serology. After this procedure, lactulose H2 breath test will be performed to exclude SIBO (≥20 ppm H2 rise only after 90 min). In case of negative lactulose H2 breath test, another LHBT will be carried out
• • slow oro-cecal transit: clinical signs and typical findings on the tests (the LHBT is normal, but the increase of blood glucose level is less than 1.1 mmol/l and/or no H2 rise during lactulose H2 breath test)
• • milk allergy (positive IgE test)