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

NCT05100719 | Not Yet Recruiting DMC

• 1 other identifier: IV/4455-3/2021/EKU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Lactose Intolerance; Lactose Malabsorption

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (6)

• improvement in stool consistency

  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 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 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

  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)

  At the time of patient enrollment and after two weeks of treatments this test will be carried out again.

Study Arms (2)

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.

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.

Drug: alverin-citrate + simethicone with placebo

Interventions

alverine-citrate + simethicone and lactase DRUG

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

Also known as: lactase

alverine-citrate + simethicone and lactase

alverin-citrate + simethicone with placebo DRUG

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

Also known as: placebo

alverin-citrate + simethicone with placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

Location

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Related Links

• 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.

MeSH Terms

Conditions

Irritable Bowel Syndrome; Lactose Intolerance

Interventions

mebeverine; Simethicone; Lactase

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Divison of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 29, 2021
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Immediately following publication. No end date
• Access Criteria: With anyone who wishes to access the data. For any purpose of analyses.

Locations

HU (1)