Irritable Bowel SyndromeLIONNCT05100719
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
A study testing alverine-citrate + simethicone and lactase in people with Irritable Bowel Syndrome and Lactose Intolerance, run by University of Pecs at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome, Lactose Intolerance, Lactose Malabsorption
- What is being tested?
- alverine-citrate + simethicone and lactase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Institute for Translational Medicine, University of Pécs
Pécs, 7624
About this study
Official title: The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION Trial): Protocol of a Multicentre Randomized Controlled Clinical 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.
Read the detailed description
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.
- Being tested
- alverine-citrate + simethicone and lactase, alverin-citrate + simethicone with placebo
- Keywords
- irritable bowel syndrome, lactose intolerance, lactose malabsorption, lactase, simethicone, alverine-citrate, placebo
- Medical subject headings
- Irritable Bowel Syndrome, Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alverine-citrate + simethicone and lactaseDrug
Also called lactase
Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
alverin-citrate + simethicone with placeboDrug
Also called placebo
Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
| Study group | Role | What they receive |
|---|---|---|
| alverine-citrate + simethicone and lactase | Active comparator | 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. Receives: Drug: alverine-citrate + simethicone and lactase |
| alverin-citrate + simethicone with placebo | Placebo comparator | 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. Receives: Drug: alverin-citrate + simethicone with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The one- and two-week total symptom score (TSS) change compared to baseline value.
Secondary outcomes (6)
improvement in stool consistency
stool consistency score of <5, according to the Bristol stool chart
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At the time of patient enrollment and after two weeks of treatments LHBT and LTT will be carried out again.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- LION is a two-armed, randomized, double-blind, placebo-controlled, two-phase clinical trial. In the first phase, we will enroll 100 patients, the allocation ratio will be 1:1 (50 patinets in each arm). Then, an interim analysis will be performed to determine the appropriate sample size. During the interim analysis, if there is already significant difference (p\<0.0294) between the arms, the recruitment will be considered completed; otherwise, recruitment will continue until the desired sample size is reached. If there is no hope for ascertaining significance, the study will be stopped.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, József Czimmer, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100719
- Sponsor's protocol ID
- IV/4455-3/2021/EKU
- Acronym
- LION
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
PubMed 16678561Borghini R, Donato G, Alvaro D, Picarelli A. New insights in IBS-like disorders: Pandora's box has been opened; a review. Gastroenterol Hepatol Bed Bench. 2017 Spring;10(2):79-89.
PubMed 28702130Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
PubMed 22426087Muller-Lissner SA, Bollani S, Brummer RJ, Coremans G, Dapoigny M, Marshall JK, Muris JW, Oberndorff-Klein Wolthuis A, Pace F, Rodrigo L, Stockbrugger R, Vatn MH. Epidemiological aspects of irritable bowel syndrome in Europe and North America. Digestion. 2001;64(3):200-4. doi: 10.1159/000048862.
PubMed 11786669Drossman DA, Morris CB, Schneck S, Hu YJ, Norton NJ, Norton WF, Weinland SR, Dalton C, Leserman J, Bangdiwala SI. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol. 2009 Jul;43(6):541-50. doi: 10.1097/MCG.0b013e318189a7f9.
PubMed 19384249Agarwal N, Spiegel BM. The effect of irritable bowel syndrome on health-related quality of life and health care expenditures. Gastroenterol Clin North Am. 2011 Mar;40(1):11-9. doi: 10.1016/j.gtc.2010.12.013.
PubMed 21333898Dean BB, Aguilar D, Barghout V, Kahler KH, Frech F, Groves D, Ofman JJ. Impairment in work productivity and health-related quality of life in patients with IBS. Am J Manag Care. 2005 Apr;11(1 Suppl):S17-26.
PubMed 15926760Simren M, Svedlund J, Posserud I, Bjornsson ES, Abrahamsson H. Health-related quality of life in patients attending a gastroenterology outpatient clinic: functional disorders versus organic diseases. Clin Gastroenterol Hepatol. 2006 Feb;4(2):187-95. doi: 10.1016/s1542-3565(05)00981-x.
PubMed 16469679Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
PubMed 26255043Hillila MT, Farkkila NJ, Farkkila MA. Societal costs for irritable bowel syndrome--a population based study. Scand J Gastroenterol. 2010 May;45(5):582-91. doi: 10.3109/00365521003637211.
PubMed 20166844Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
PubMed 22730468Miller V, Hopkins L, Whorwell PJ. Suicidal ideation in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2004 Dec;2(12):1064-8. doi: 10.1016/s1542-3565(04)00545-2.
PubMed 15625650Yang J, Fox M, Cong Y, Chu H, Zheng X, Long Y, Fried M, Dai N. Lactose intolerance in irritable bowel syndrome patients with diarrhoea: the roles of anxiety, activation of the innate mucosal immune system and visceral sensitivity. Aliment Pharmacol Ther. 2014 Feb;39(3):302-11. doi: 10.1111/apt.12582. Epub 2013 Dec 5.
PubMed 24308871Lomer MC, Parkes GC, Sanderson JD. Review article: lactose intolerance in clinical practice--myths and realities. Aliment Pharmacol Ther. 2008 Jan 15;27(2):93-103. doi: 10.1111/j.1365-2036.2007.03557.x. Epub 2007 Oct 23.
PubMed 17956597Suchy FJ, Brannon PM, Carpenter TO, Fernandez JR, Gilsanz V, Gould JB, Hall K, Hui SL, Lupton J, Mennella J, Miller NJ, Osganian SK, Sellmeyer DE, Wolf MA. National Institutes of Health Consensus Development Conference: lactose intolerance and health. Ann Intern Med. 2010 Jun 15;152(12):792-6. doi: 10.7326/0003-4819-152-12-201006150-00248. Epub 2010 Apr 19. No abstract available.
PubMed 20404261
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION Trial): Protocol of a Multicentre Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05100719
- Acronym / sponsor ID
- LION / IV/4455-3/2021/EKU
- Keywords
- irritable bowel syndrome, lactose intolerance, lactose malabsorption, lactase, simethicone, alverine-citrate, placebo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- LION is a two-armed, randomized, double-blind, placebo-controlled, two-phase clinical trial. In the first phase, we will enroll 100 patients, the allocation ratio will be 1:1 (50 patinets in each arm). Then, an interim analysis will be performed to determine the appropriate sample size. During the interim analysis, if there is already significant difference (p<0.0294) between the arms, the recruitment will be considered completed; otherwise, recruitment will continue until the desired sample size is reached. If there is no hope for ascertaining significance, the study will be stopped.
| Arm | Type | Receives |
|---|---|---|
| alverine-citrate + simethicone and lactase | Active comparator | Drug: alverine-citrate + simethicone and lactasePatients 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. |
| alverin-citrate + simethicone with placebo | Placebo comparator | Drug: alverin-citrate + simethicone with placeboPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alverine-citrate + simethicone and lactaseAlso: lactasePatients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase. | Drug | alverine-citrate + simethicone and lactase |
| alverin-citrate + simethicone with placeboAlso: placeboPatients in the second arm receive alverin-citrate + simethicone with placebo without lactase. | Drug | alverin-citrate + simethicone with placebo |
Primary outcome
change of the symptoms measured by TSS (total symptom score)
Time frame: The one- and two-week total symptom score (TSS) change compared to baseline value.
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.
6 secondary outcomes
improvement in stool consistency
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
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
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
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)
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
Time frame: At the time of patient enrollment and after two weeks of treatments LHBT and LTT will be carried out again.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 16678561Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
- Background: PubMed 28702130Borghini R, Donato G, Alvaro D, Picarelli A. New insights in IBS-like disorders: Pandora's box has been opened; a review. Gastroenterol Hepatol Bed Bench. 2017 Spring;10(2):79-89.
- Background: PubMed 22426087Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
- Background: PubMed 11786669Muller-Lissner SA, Bollani S, Brummer RJ, Coremans G, Dapoigny M, Marshall JK, Muris JW, Oberndorff-Klein Wolthuis A, Pace F, Rodrigo L, Stockbrugger R, Vatn MH. Epidemiological aspects of irritable bowel syndrome in Europe and North America. Digestion. 2001;64(3):200-4. doi: 10.1159/000048862.
- Background: PubMed 19384249Drossman DA, Morris CB, Schneck S, Hu YJ, Norton NJ, Norton WF, Weinland SR, Dalton C, Leserman J, Bangdiwala SI. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol. 2009 Jul;43(6):541-50. doi: 10.1097/MCG.0b013e318189a7f9.
- Background: PubMed 21333898Agarwal N, Spiegel BM. The effect of irritable bowel syndrome on health-related quality of life and health care expenditures. Gastroenterol Clin North Am. 2011 Mar;40(1):11-9. doi: 10.1016/j.gtc.2010.12.013.
- Background: PubMed 15926760Dean BB, Aguilar D, Barghout V, Kahler KH, Frech F, Groves D, Ofman JJ. Impairment in work productivity and health-related quality of life in patients with IBS. Am J Manag Care. 2005 Apr;11(1 Suppl):S17-26.
- Background: PubMed 16469679Simren M, Svedlund J, Posserud I, Bjornsson ES, Abrahamsson H. Health-related quality of life in patients attending a gastroenterology outpatient clinic: functional disorders versus organic diseases. Clin Gastroenterol Hepatol. 2006 Feb;4(2):187-95. doi: 10.1016/s1542-3565(05)00981-x.
- Background: PubMed 26255043Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
- Background: PubMed 20166844Hillila MT, Farkkila NJ, Farkkila MA. Societal costs for irritable bowel syndrome--a population based study. Scand J Gastroenterol. 2010 May;45(5):582-91. doi: 10.3109/00365521003637211.
- Background: PubMed 22730468Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
- Background: PubMed 15625650Miller V, Hopkins L, Whorwell PJ. Suicidal ideation in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2004 Dec;2(12):1064-8. doi: 10.1016/s1542-3565(04)00545-2.
- LION is designed and coordinated by the Centre for Translational Medicine (Medical School, University of Pécs). This link redirects to the official website of the institute.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alverine-citrate + simethicone and lactase in people with Irritable Bowel Syndrome and Lactose Intolerance, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the symptoms measured by TSS (total symptom score) (time frame: The one- and two-week total symptom score (TSS) change compared to baseline value.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100719, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.