The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pecs
About this trial
Irritable bowel syndrome (IBS) is a functional gastrointestinal disease. There is no well-defined pharmacological treatment. This clinical trial is a prospective, double-blind, two-armed randomized controlled, single-center trial. It is created to examine the role of IBS in patients with lactose intolerance. IBS patients undergo lactose H2 breath test (LHBT) and lactose tolerance test (LTT). Those with positive LTT and LHBT will be randomized into two groups: alverine-citrate + simethicone and lactase group (1) or alverin-citrate + simethicone with the placebo group (2). The goal of this study is to compare the lactase enzyme with placebo in IBS patients with lactose intolerance.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- alverine-citrate + simethicone and lactase
- alverin-citrate + simethicone with placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov