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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
alverine-citrate + simethicone and lactase
DrugPatients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
alverin-citrate + simethicone with placebo
DrugPatients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: alverine-citrate + simethicone and lactaseActive comparator 1 intervention
Group B: alverin-citrate + simethicone with placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
change of the symptoms measured by TSS (total symptom score)
The primary outcome is the number of enrolled patients with significant improvement in each treatment arm. Significant improvement is considered if there is \>50% reduction in the TSS, compared to the baseline symptoms.
Time frame
The one- and two-week total symptom score (TSS) change compared to baseline value.Secondary outcomes
1
improvement in stool consistency
stool consistency score of \<5, according to the Bristol stool chart
Time frame
The two time points at which the measurement is assessed are the time of enrollment and after 2 weeks.2
the absence of a bowel movement
The absence of a bowel movement is accompanied by an improvement of ≥30 mm in the VAS (visual analogue scale) for the worst abdominal pain.
Time frame
The three time points at which the measurement is assessed are the time of enrollment, after 1 and 2 weeks.3
relief of IBS-related bloating
The number of patients with acceptable relief of IBS-related bloating determined by a questionnaire, from the response (yes or no) compare to the baseline IBS-related bloating.
Time frame
The three time points at which the measurement is assessed are the time of enrollment, after 1 and 2 weeks.4
Onset and duration of relief of bloating
Onset and duration of relief of bloating is measured by a questionnaire.
Time frame
The three time points at which the measurement is assessed are the time of enrollment, after 1 and 2 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
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