An interventional study of alverine-citrate + simethicone and lactase and alverin-citrate + simethicone with placebo in Irritable Bowel Syndrome, Lactose Intolerance and Lactose Malabsorption, sponsored by University of Pecs. Not yet recruiting at 1 site in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by University of Pecs · Not applicable, Interventional, and Treatment
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.
Irritable bowel syndrome (IBS) is one of the most frequently diagnosed gastroenterological disorders and can lead to significant deterioration of quality of life and an increase in health care and societal costs. Patients with lactose intolerance are unable to fully digest lactose caused by lactose malabsorption. The undigested lactose moves into the large intestine, fermented by bacteria, and causes bloating, gas, and diarrhea symptoms. The two, most frequently used diagnostic methods are the lactose H2 breath test (LHBT) and the lactose tolerance test (LTT). The restriction of lactose input or the replacement of the lactase enzyme can lead to the relief of the symptoms. Lactose intolerance is a common disorder among patients with IBS, it is more frequent than in the general population.
There are no studies that assess the link between lactose intolerance and IBS. Our primary objective is the examination of the relationship between lactose intolerance and IBS with or without the replacement of lactase enzyme. Our secondary objectives are to compare the lactase/beta-galactosidase enzyme replacement with placebo with the evaluation of a TSS (Total symptom score), VAS (Visual Analog Scale), QoL (Quality of life) questionnaires. The other secondary outcomes are to compare the severity of baseline symptoms during and after lactose administration.
Patients diagnosed with IBS according to the Rome IV criteria will test with LTT and LHBT.
Who has positive LTT and LHBT will randomize into two groups: (1) alverine-citrate + simethicone and lactase; (2) alverin-citrate + simethicone with placebo.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University of Pecs is the lead sponsor of 106 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with irritable bowel syndrome based on the ROME IV criteria will go through a lactase intolerance test (LTT) and (lactose H2 breath test) LHBT. Those who have positive LTT and LHBT will receive alverine-citrate + simethicone and lactase.
Drug: alverine-citrate + simethicone and lactase
Patients diagnosed with irritable bowel syndrome based on the ROME IV criteria will go through a lactase intolerance test (LTT) and (lactose H2 breath test) LHBT. Those who have positive LTT and LHBT will receive alverine-citrate + simethicone with placebo.
Drug: alverin-citrate + simethicone with placebo
Drug pages: Alverine · Simethicone · Lactase
Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
Also known as: lactase
Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
Also known as: placebo
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.
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.
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.
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.
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.
incidence of Small intestinal bacterial overgrowth (SIBO)
Early (within 90 minutes), significant (≥20 ppm) H2 rise during LHBT or lactulose breath test compared to the baseline value.
Time frame: At the time of patient enrollment and after two weeks of treatments this test will be carried out again.
results of LHBT and LTT
Results of LHBT (lactose H2 breath test) and LTT (lactose tolerance test).
Time frame: At the time of patient enrollment and after two weeks of treatments LHBT and LTT will be carried out again.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Immediately following publication. No end date
Access criteria: With anyone who wishes to access the data. For any purpose of analyses.
This study is not yet recruiting, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Alverine · Simethicone · Lactase