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

Primary Purpose

Irritable Bowel Syndrome, Lactose Intolerance, Lactose Malabsorption

Status

Not yet recruiting

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

alverine-citrate + simethicone and lactase

alverin-citrate + simethicone with placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, lactose intolerance, lactose malabsorption, lactase, simethicone, alverine-citrate, placebo

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Institute for Translational Medicine, University of Pécs

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

alverine-citrate + simethicone and lactase

alverin-citrate + simethicone with placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

improvement in stool consistency

stool consistency score of <5, according to the Bristol stool chart

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.

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.

Onset and duration of relief of bloating

Onset and duration of relief of bloating is measured by a questionnaire.

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.

results of LHBT and LTT

Results of LHBT (lactose H2 breath test) and LTT (lactose tolerance test).

Full Information

NCT ID

NCT05100719

First Posted

September 29, 2021

Last Updated

October 19, 2021

Sponsor

University of Pecs

1. Study Identification

Unique Protocol Identification Number

NCT05100719

Brief Title

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

Acronym

LION

Official Title

The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION Trial): Protocol of a Multicentre Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pecs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Lactose Intolerance, Lactose Malabsorption

Keywords

irritable bowel syndrome, lactose intolerance, lactose malabsorption, lactase, simethicone, alverine-citrate, placebo

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

alverine-citrate + simethicone and lactase

Arm Type

Active Comparator

Arm Description

Arm Title

alverin-citrate + simethicone with placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

alverine-citrate + simethicone and lactase

Other Intervention Name(s)

lactase

Intervention Description

Patients who randomized in the first arm are treated with alverine-citrate + simethicone and lactase.

Intervention Type

Drug

Intervention Name(s)

alverin-citrate + simethicone with placebo

Other Intervention Name(s)

placebo

Intervention Description

Patients in the second arm receive alverin-citrate + simethicone with placebo without lactase.

Primary Outcome Measure Information:

Title

change of the symptoms measured by TSS (total symptom score)

Description

Time Frame

The one- and two-week total symptom score (TSS) change compared to baseline value.

Secondary Outcome Measure Information:

Title

improvement in stool consistency

Description

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.

Title

the absence of a bowel movement

Description

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.

Title

relief of IBS-related bloating

Description

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.

Title

Onset and duration of relief of bloating

Description

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.

Title

incidence of Small intestinal bacterial overgrowth (SIBO)

Description

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.

Title

results of LHBT and LTT

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Institute for Translational Medicine, University of Pécs

City

Pécs

ZIP/Postal Code

7624

Country

Hungary

12. IPD Sharing Statement

Plan to Share 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.

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Links:

URL

http://tm-centre.org/

Description

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.

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

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