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

October 19, 2021 updated by: József Czimmer, University of Pecs

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Pécs, Hungary, 7624
        • Institute for Translational Medicine, University of Pécs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 and lactase.
Drug: alverine-citrate + simethicone and lactase
Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.
Other Names:
  • lactase
Placebo Comparator: alverin-citrate + simethicone with placebo
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
Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The one- and two-week total symptom score (TSS) change compared to baseline value.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
stool consistency score of <5, according to the Bristol stool chart
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.
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.
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.
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.
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.
Onset and duration of relief of bloating is measured by a questionnaire.
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.
Early (within 90 minutes), significant (≥20 ppm) H2 rise during LHBT or lactulose breath test compared to the baseline value.
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 of LHBT (lactose H2 breath test) and LTT (lactose tolerance test).
At the time of patient enrollment and after two weeks of treatments LHBT and LTT will be carried out again.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV/4455-3/2021/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

With anyone who wishes to access the data. For any purpose of analyses.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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